Food and Chemical Toxicology 42 (2004) 1531–1542

www.elsevier.com/locate/foodchemtox

A review of the clinical toleration studies of polydextrose in food

M.T. Flood a, M.H. Auerbach b,*
, S.A.S. Craig b

a
Keller & Heckman LLP, 1001 G Street, Washington, DC 20001, USA
b
Danisco USA Inc., 440 Saw Mill River Road, Ardsley, NY 10502, USA
Received 16 February 2004; accepted 25 April 2004

Abstract
Polydextrose is a non-digestible 1 kcal/g polysaccharide used primarily as a sugar replacer and dietary fiber in foods. At typical
use levels, polydextrose provides physiological effects similar to those of other dietary fibers. However, excessive consumption of
non-digestible carbohydrates can lead to gastrointestinal distress. Nine clinical studies were conducted with polydextrose to evaluate
the extent of such symptoms. These studies determined laxation endpoints in adults and children, and showed that polydextrose was
better tolerated than most other low digestible carbohydrates (e.g. polyols). This is because of a higher molecular weight and partial
colonic fermentation, leading to a lower risk of osmotic diarrhea. After evaluating these studies, the Joint FAO/WHO Expert
Committee on Food Additives (JECFA) and the European Commission Scientific Committee for Food (EC/SCF) concluded that
polydextrose has a mean laxative threshold of
90 g/d (1.3 g/kg bw) or 50 g as a single dose.
Ó 2004 Published by Elsevier Ltd.

Keywords: Polydextrose; Toleration; Laxation; Non-digestible carbohydrates; Dietary fiber

1. Introduction to acceptance of polydextrose as a dietary fiber in many

Polydextrose is a low molecular weight randomly
bonded polysaccharide of glucose with energy utiliza-
tion of 1 kcal/g (Achour et al., 1994; Figdor and
Rennhard, 1981; Juhr and Franke, 1992). It is prepared
by the bulk melt polycondensation of glucose and sor-
bitol with small amounts of food grade acid in vacuo.
All possible glycosidic linkages with the anomeric car-
bon of glucose are present: a and b 1-2, 1-3, 1-4 and 1-6;
the 1-6 linkages predominate. It has an average degree
of polymerization (DP) of 12 and an average molecular
weight of 2000.
FDA extensively studied polydextrose for safety prior
to its 1982 approval as a food additive under 21 CFR
§172.841 (Burdock and Flamm, 1999). It has attained
significant use as a low calorie bulking agent to replace
sugar in reduced calorie foods (Mitchell et al., 2001).
The low calorie content of polydextrose is a result of its
poor digestibility in the small intestine and incomplete
fermentation in the large intestine. This property has led
*
Corresponding author.
E-mail address: michael.auerbach@danisco.com (M.H. Auerbach).
0278-6915/$ - see front matter Ó 2004 Published by Elsevier Ltd.
doi:10.1016/j.fct.2004.04.015
countries (Craig et al., 1999).
Partially digestible carbohydrates and related com-
pounds exert overall beneficial effects on gastrointestinal
function when ingested at low to moderate doses
(Cummings, 1983). These effects include improved
bowel function (e.g. prevention of constipation), en-
hanced environment for the growth of such beneficial
bacteria as Lactobacillus and Bifidobacterium species
and thereby decreased formation of harmful bacterial
metabolites, and regeneration of colonic mucosa
(Kripke et al., 1989). Fermentation by colonic flora
yields the short chain fatty acids (SCFA) acetic, propi-
onic and butyric and small amounts of carbon dioxide,
methane and hydrogen gases. The host rapidly and al-
most completely absorbs these products. The SCFA are
utilized via established metabolic pathways and are
energetically fully available. The gaseous products are
largely expired in the breath. This is a normal process
for metabolism of non-absorbed oligosaccharides (e.g.
raffinose), resistant starch, non-digested plant gums and
soluble fibers, secreted glycoproteins and mucopolysac-
charides (Salyers, 1985).
However, excessive consumption of fermentable car-
bohydrates can lead to gastrointestinal distress such as
1532 M.T. Flood et al. / Food and Chemical Toxicology 42 (2004) 1531–1542
bloating, abdominal cramps (colic), flatus/gas, soft
stools, borborygmi, and in extreme cases diarrhea, in
sensitive individuals (Sandler et al., 2000). Ingredients
causing similar effects include, but are not limited to,
polyols (e.g., lactitol, sorbitol, maltitol), lactulose,
fructo-oligosaccharides (FOS), and many ingredients
known collectively as dietary fiber (e.g., cellulose, cereal
bran, xanthan and guar gums, etc.). These gastrointes-
tinal manifestations are transient and cease promptly
upon cessation or reduction of intake of the responsible
food, although subjects often develop improved toler-
ance over time. Therefore, these high dose effects are not
symptoms of toxicity but rather represent a normal
consequence of overloading the GI tract.
Nine clinical studies in adults and children were
conducted with polydextrose to evaluate the extent of
such symptoms. The Joint FAO/WHO Expert Com-
mittee on Food Additives (JECFA) in 1987 and the
European Commission Scientific Committee for Food
(EC/SCF) in 1990 allocated to polydextrose an
Acceptable Daily Intake (ADI) ‘‘not specified’’ after
reviewing these studies. This means that neither agency
found it necessary to stipulate an upper level of safe
intake because excessive consumption is a matter of
tolerance rather than safety. Therefore, polydextrose is
permitted for use in any food at any level without
restriction other than good manufacturing practice
(GMP) in most markets. The US, however, allows
polydextrose use as a food additive in specific foods
only, and requires that ‘‘The label and labeling of food a
single serving of which would be expected to exceed 15 g
of the additive shall bear the statement: ‘Sensitive indi-
viduals may experience a laxative effect from excessive
consumption of this product’.’’ JECFA did conclude
that the threshold for laxation was at an intake of about
90 g polydextrose per person per day, or 50 g as a single
dose (JECFA, 1987). In comparison, a daily dose of 20 g
was found acceptable for sugar alcohols by the EC/SCF
(1985). The SCF rapporteur pointed out, however, that
such estimates are only provided as a guide and should
not be used to establish maximum levels of use (van
Esch, 1987).
This paper discusses the clinical findings for poly-
dextrose that have not heretofore been published in the
open literature, and compares the results with studies on
similar substances.
2. The nature of laxation
The term laxation encompasses a broad spectrum of
gastrointestinal effects, including but not limited to: in-
creased stool weight and water content; decreased GI
transit time; loose stools; bloating and distention; bor-
borygmi; abdominal discomfort; flatus; and, in extreme
cases, diarrhea. Clearly such symptoms are quite com-
mon in the general population and may arise from a
variety of causes. In a recent survey, 40.5% of 1017
individuals reported one or more adverse digestive
symptoms, including abdominal pain or discomfort,
bloating or distension, or diarrhea or loose stools within
the previous month (Sandler et al., 2000). Many of these
symptoms, which fall within the overall term of ‘‘laxa-
tion,’’ are associated with consumption of poorly di-
gested dietary ingredients, including beans, cabbage,
apples, onions and plums, and to excessive consumption
of other foods containing added fiber ingredients. Some
of these effects are considered to be beneficial if they
result from consumption of dietary fiber. In 2002 the US
National Academy of Sciences Dietary Reference Intake
expert panel subcommittee on dietary fiber said:
Consumption of certain Dietary and Functional Fi-
bers is known to improve laxation and ameliorate
constipation (Burkitt et al., 1972; Cummings
et al., 1978; Kelsay et al., 1978; Lupton et al.,
1993). In most reports, there is a strong positive
correlation between intake of Dietary Fiber and
daily fecal weight (Birkett et al., 1997). Also,
Dietary Fiber intake is usually negatively correlated
with transit time (Birkett et al., 1997). . .. At the
same time, a number of studies have shown that
low fiber intake is associated with constipation.
For example, Morais and coworkers (1999) re-
ported that children with chronic constipation had
lower Dietary Fiber intake than the control group.
The authors concluded that a low intake of fiber
is a risk factor for chronic constipation in chil-
dren. . .. Although what constitutes ‘‘constipation’’
is variously defined, diets that increase the number
of bowel movements per day, improve the ease with
which a stool is passed, or increase fecal bulk are
considered to be of benefit. (Panel on DRI, 2002,
pp. 7–23; bold emphasis added.)
Although some effects of laxation may be unpleasant,
only diarrhea, particularly chronic diarrhea, is poten-
tially health threatening. Diarrhea can be caused by
several factors in addition to excessive consumption of
dietary fiber, including ingestion of bacteria-contami-
nated food, intestinal viral or protozoic infections, and
irritable bowel syndrome. Diarrhea may also result from
food intolerances and more serious illnesses, such as
Crohn’s disease or colonic tumors (CDC, 1999). In the
United States, the prevalence of lactose maldigestion,
which also may produce diarrhea, is reportedly 15%
among whites, 53% among Mexican–Americans and
80% among blacks. Internationally, it is estimated that
about two thirds of the world adult population lacks the
enzyme necessary to metabolize lactose, the sugar found
in dairy products (Vesa et al., 2000). Even fructose,
occurring in apple juice, may not be completely meta-
 M.T. Flood et al. / Food and Chemical Toxicology 42 (2004) 1531–1542
bolized in young children, resulting in non-specific
diarrhea (Kneepkens et al., 1989).
Two phenomena––osmotic and fermentation ef-
fects––largely determine intestinal toleration of non-
digestible components. Osmotic diarrhea occurs when
excess ingestion of a non-digestible substance passes
from the small intestine into the colon, where resident
bacteria may ferment it. As the substance passes
through the small intestine, water is absorbed by
osmosis to reduce its concentration. This water is re-
tained in the colon and may be expelled with the indi-
gestible substance as diarrhea. Fermentation of fiber
substances by colonic bacteria may convert significant
portions of otherwise indigestible substances to short
chain fatty acids, of which a large fraction is absorbed
and ultimately converted to energy. Although these bio-
reactions also liberate gases, such as hydrogen, methane
and carbon dioxide, and can produce flatus, occurrence
of osmotic diarrhea is markedly reduced by this fer-
mentation because the concentration of the indigestible
material, and the resulting osmotic pressure, is reduced.
The mitigating effects of bacterial fermentation on
diarrhea were demonstrated by Hammer et al. (1989),
who compared the diarrhea induced by ingestion of
polyethylene glycol, an indigestible compound that is
not fermented by bacteria in the colon, to diarrhea in-
duced by lactulose, an indigestible carbohydrate that is
fermented. Incidences of diarrhea due to increasing
doses of lactulose were significantly lower than corre-
sponding incidences from polyethylene glycol until a
threshold dose of lactulose was attained, at which point
laxation effects were similar. The threshold dose was the
dose at which lactulose exceeded the ability of resident
bacteria to efficiently metabolize the substance.
The role of osmolarity versus colonic fermentation of
low digestible carbohydrates was analyzed by compar-
ing laxative effects induced by lactulose and Idolex, a
fructo-oligosaccharide having an average degree of
polymerization (DP) of about 4 (Clausen et al., 1998).
Based on its higher average molecular weight, Idolex
possessed about 56% of the osmotic force of lactulose.
In preliminary in vitro experiments, it was shown that
the rates of colonic fermentation of the two substances
were virtually identical. Twelve subjects were then given
increasing doses (0, 20, 40, 80, 160 g/day) of each sub-
stance in a crossover design. It was found that in one-
third of the participants, fermentation efficiency was so
high that the laxative effect from both substances was
abolished at doses as high as 80–160 g/day. In subjects
having a lower capacity for fermentative disposal of the
low digestible carbohydrates, laxation, as measured by
fecal volume, increased at lower doses in a ratio pro-
portional to the osmotic force of the carbohydrate.
Twice the weight of Idolex was needed to produce a
laxative effect similar to that from a given weight of
lactulose.
1533
Since osmotic pressure is proportional to the number
of molecules, rather than the weight of the molecules,
minimum laxative doses are found to increase with
increasing molecular weight of the ingested substance.
Low molecular weight monosaccharide polyols, such as
sorbitol or mannitol, generally induce laxation at lower
doses than higher molecular weight disaccharide poly-
ols, such as maltitol or isomalt, or oligosaccharides such
as fructo-oligosaccharide (Hata and Nakajima, 1984).
Polydextrose, having a much higher molecular weight,
would be expected to induce laxation only at much
higher doses than the polyols. It is known from
metabolism studies in rats and humans that less than
half of ingested polydextrose is fermented in the large
intestine, the remainder being excreted in the feces
(Figdor and Rennhard, 1981; Juhr and Franke, 1992;
Achour et al., 1994). Therefore, laxation can be induced
by ingestion of polydextrose, but the threshold dose is
higher than that of lower molecular weight, low digest-
ible carbohydrates that reach the large intestine
(Großklaus, 1990; Livesey, 2001).
Evaluation and comparison of the outcomes of dif-
ferent studies are complicated by the different endpoints
that are measured and the way they are reported. Be-
cause individual sensitivities vary, and the sensitivity of
the same individual may vary from day to day, reports
of mean laxative thresholds, with associated standard
deviations, are preferred because they explicitly account
for variations within a population. In such a study,
participants receive increasing doses of test substance
until a predetermined laxative effect is observed, defined
as the laxative threshold for that individual. The arith-
metic mean of the laxative thresholds of all participants
is the mean laxative threshold (Table 1). Those studies
reporting a ‘‘minimum laxative dose’’ or ‘‘minimum
effective dose’’, the lowest dose at which any subject
reported laxation in a given study, should be treated
with caution, for the results are inevitably dependent on
the number of participants in the study, and an adequate
control population is essential due to the prevalence of
gastrointestinal symptoms in the general population.
Table 1
Definitions used in this article
Borborygmi (singular us)––rumblings in the bowels due to flatulence
Diarrhea––frequent, watery, and difficult to control bowel
movements
Flatus––gas in the intestines
Laxation––defecation. In the context of low digestible carbohydrate
ingestion, laxation is sometimes used interchangeably with
diarrhea
Mean laxative threshold––the mean dose at which participants
in a given study first experienced diarrhea, the arithmetic mean
of the individual laxative thresholds
Maximum no-effect dose, or maximum tolerated dose––the highest
dose at which no participant in a given study experienced diarrhea
1534 M.T. Flood et al. / Food and Chemical Toxicology 42 (2004) 1531–1542
In comparing studies in which laxative effects are
reported, priority is given to those studies in which
diarrhea was a major endpoint and was carefully de-
fined. There is a discrepancy between the clinical defi-
nition and popular understanding. Commonly accepted
criteria for clinical diarrhea are (1) elevated stool output
(>200–250 g/day); (2) watery, difficult to control bowel
movements; and (3) frequency of bowel movements
exceeding 3 per day (McRorie et al., 2000). In the
McRorie et al. study, when placebo, olestra, or sorbitol
was administered to 66 subjects, 38% of the bowel
movements in the study were rated by the subjects as
‘‘diarrhea’’, yet only 2% of treatment days met the
commonly accepted criteria for clinical diarrhea.
Accordingly, since several effects of laxation are known
to be beneficial, and only diarrhea is of potential con-
cern as a safety issue, this paper focuses on quantifiable
reports of the occurrence of diarrhea associated with the
consumption of polydextrose vs other dietary fiber
ingredients.
3. Laxation studies on polydextrose
3.1. Materials and methods
3.1.1. Test substance and study sites
Pfizer Inc, Groton, CT, provided the commercial
polydextrose for these studies. Four of the nine studies
were conducted at Pfizer’s Groton, CT facility. Other
studies were conducted at Miamiville, OH (Bunde), New
Orleans, LA (McMahon), Cambridge, MA (Scrimshaw
and Young), San Antonio, TX (Beer) and Lincoln, NE
(Curtis) (see Tables 2 and 3). The first seven studies
outlined below were reported as Volume 10 of the
Polydextrose Food Additive Petition 9A3441, December
14, 1978.
3.1.2. Study Protocols
1. Alter (1974). In a single-blind study, 20 male volun-
teers, 21–59 years of age, received 75 g polydextrose
daily for 2 weeks and 150 g daily in the third week.
The test substance was administered in the form of
a chocolate milk drink three times a day after meals.
A parallel control group of nine volunteers received
the chocolate milk drink containing maltodextrin. A
2 week baseline period preceded administration of
polydextrose or the placebo.
Feces were analyzed weekly for pH, water retention,
total lipids, nitrogen, calcium and potassium. Gas-
trointestinal transit times were measured during the
week prior to administration of polydextrose and
during the following 2 weeks using an inert dye
marker. Differences between parameters in the pla-
cebo and treated groups were evaluated using the
standard t-test.
2. Knirsch (1974). In a double-blind study to determine
the effects of ingestion of polydextrose in a normal
diet, 57 male volunteers, ages 21–54, received 0, 35
or 75 g polydextrose per day. The volunteers were di-
vided into nine groups of 6, with three groups having
an extra subject. Three groups received a normal diet,
three groups received 35 g polydextrose per day in
their diet, and three groups received 75 g/day in their
diet. Polydextrose (or sucrose/maltodextrin for the
control group) was administered in two portions with
breakfast (in either fruit juice or maple syrup) and
lunch (in either soup, salad dressing, dessert, or coffee
sweetener). The 75 g polydextrose group received a
third portion at coffee break using gumdrops and
cookies. The study was conducted for 2 weeks,
excluding the weekends.
Subjects responded daily to seven questions about the
effects of the diet on eating or bowel habit. One-way
analysis of variance on (0,1) data with Tukey-type
contrasts was used in evaluating the responses.
3. Raphan (1975a). Twenty-one male and female volun-
teers, 21–47 years of age, received increasing doses of
polydextrose, sorbitol, and placebo (maltodextrin) in
a double-blind, single three-sided Latin Square de-
signed study. Subjects were randomly assigned to
one of three groups. All subjects received each of
the test substances three times daily in a fruit flavored
drink with a meal (AM), in a gelatin dessert with a
meal (noon), and in ice cream (3:30 PM). Each test
segment lasted 10 days. Polydextrose and the placebo
were administered at initial doses of 40 g/day. The ini-
tial dose of sorbitol was 20 g/day. All doses were in-
creased 10 g/day up to a maximum dose of 130 g/
day for polydextrose and placebo and 110 g/day for
sorbitol. Each participant consumed increasing doses
until his or her tolerance had been exceeded, a pre-
determined laxation endpoint was reached, or the
maximum scheduled dose had been received. Adminis-
tration of doses was then discontinued until symptoms
returned to normal, when testing of the next sub-
stance began. The laxation endpoint was determined
by a complex rating system not limited to diarrhea
but also including number and frequency of move-
ments and degree of ‘‘urgency’’.
Mean maximum doses were analyzed using two-way
analysis of variance. To examine the possible effect of
the order in which the substances were tested, Latin
Square analysis of variance was performed on the
group cell means.
4. Raphan (1975b). In a double-blind study designed to
examine possible effects of long-term ingestion of
polydextrose, 51 men and women, ages 12–60, were
randomly assigned to eight groups, of which two were
placebo (confectioners sugar) groups (13 volunteers).
Those in the treatment groups received 30 g polydext-
rose per day in 3 divided doses, with regular meals
 M.T. Flood et al. / Food and Chemical Toxicology 42 (2004) 1531–1542 1535

Table 2
Clinical toleration studies of polydextrose
Investigator Site Year Total subjects Duration Highest dose g Diarrhea episodesa
single/daily
Alter Pfizer 1974 20 male adults 3 weeks 50–150 11 PDX; 5 placebo
Knirsch Pfizer 1974 57 male adults 10 days 24–79 2 at 35 g/day
McMahon Tulane Univ. 1974 10 Type 2 diabetics Single dose 50–50 4 PDX; 2 glucose
Raphan-a Pfizer 1975 21 adults––11M/10F 10 days 43–130 None
Raphan-b Pfizer 1975 51 adults––31M/20F 12 weeks 20–60 1 at 45 + 60 g/day
Bunde Hill Top Res. 1975 11 children ages 2–3 6 weeks 10–15 4 at 15 g/day
’’ 11 children ages 4–6 6 weeks 10–20 1 at 20 g/day
’’ 12 children ages 7–9 6 weeks 15–30 1 at 30 g/day
’’ 12 children ages 10–12 6 weeks 15–40 4 at 20 g/day
’’ 12 children ages 13–16 6 weeks 20–55 1 at 30 + 55 g/day
Scrimshaw MIT 1977 16 adults––11M/5F 8 weeks 20–50 None
and Young
Beer Univ. TX 1989 24 male adults Single dose 58–58 None
Curtis Harris Labs 1990 200 female adults Single dose 40–40b
Tomlin and Sheffield UK 1988 12 male adults 10 days 10–30 None
Read
Nakagawa Hino, Japan 1989 22 adolescent females 4 weeks 10–10 None
et al.
Zhong et al. PR China 1999 120 adults––66M/54F 4 weeks 4–12 None
Endo et al. Saitama, 1991 8 adults––6M/2F 2 weeks 15–15 None
Japan
Saku et al. Fukuoka, 1991 51 adults––25M/26F 2 months 5–15 2 in first month
Japan
Achour et al. Paris, France 1992 7 adult males 3 weeks 10–30 None
a
Individual daily transient episodes; no chronic diarrhea reported.
b
Number of occurrences not reported; relative occurrences comparable in polydextrose vs controls.

and snacks, during the first 5 weeks, 45 g/day during
weeks 6–8, and 60 g/day during weeks 9–12. Doses
were adjusted downward, if necessary, to minimize
gastrointestinal symptoms. At approximately 2 week
intervals, the subjects each took a capsule of green
dye and recorded the appearance and disappearance
of dye in their stools. The mean transit time was
calculated. Fasting blood and urine samples were
collected before treatment, at 2 week intervals
throughout the test period, and on the day following
the last test day. Hematology, clinical chemistry, and
urinalysis were performed.
Differences in blood chemistry parameters between
the treated groups and the placebo groups were
evaluated using the chi-square test statistic. Differ-
ences in mean transit times were evaluated using the
standard t-test.
5. Bunde (1975). In a 4-week study designed to examine
the possible laxation effects of polydextrose on chil-
dren, 108 children and adolescents between the ages
of 2 and 16 years of age were divided into five age
groups: ages 2–3 years, 4–6 years, 7–9 years, 10–12
years, and 13–16 years.
Members of each group received either a placebo
(sucrose and maltodextrin) or polydextrose at doses of
about 500 mg/kg bw during week one, 750 mg/kg bw
during week two, and 1000 mg/kg bw during weeks
three and four. The final doses varied from 15 g/day in
the 2–3 year group to 55 g/day in the 13–16 year group.
Eleven or 12 subjects in each group received poly-
dextrose. The test substance was administered as a
sugar substitute at breakfast; in a beverage mix, rec-
ommended to be consumed at lunch; and in ice cream
consumed in the evening. Blood and urine samples
were collected on days 0, 14, and 28 for ages 2–6 and
on days –7, 0, 14, and 28 for the older children.
Incidences of six side effects were subjected to statis-
tical analysis: frequent bowel movements, loose stools,
flatulence, diarrhea, soft stools, and constipation. For
each age group, the incidence of a given side effect in
the polydextrose subgroup was compared to the cor-
responding incidence in the placebo subgroup using
the Fisher exact test. Differences in blood chemistry
between subjects receiving polydextrose or the placebo
were analyzed using the chi-square test statistic.
6. McMahon (1974). In a double-blind study in which
the subjects served as their own controls, the effects
of polydextrose on plasma insulin and glucose kinet-
ics were examined using the standard glucose toler-
ance test. Two male and eight female Type 2
diabetics, aged 41–67, having fasted for a minimum
of 12 h prior to each day’s test, received on successive
days single doses of (1) 100 g glucose, (2) 100 g glu-
cose with 50 g polydextrose, (3) 50 g glucose, (4)
50 g glucose with 50 g polydextrose, and (5) 50 g poly-
dextrose. Blood glucose and insulin levels were mea-
sured from samples taken at baseline, 1/2, 1, 11/2, 2,
3, 4, and 5 h after dosage. Blood glucose parameters
 1536
Table 3
Summary of laxation studies on polydextrose (PDX)
Investigator, date, site Protocol Laxation endpoint Comments
Alter, 1974 20 males received 75 g/day PDX in a chocolate milk Over half of treated and control participants Author speculates that chocolate milk vehicle may have
Pfizer Central Res., for 2 weeks, 150 g/day in the third week. 9 controls dropped because of diarrhea. More G.I. contributed to symptoms, due to high incidence of diarrhea
Groton, CT symptoms in PDX group in the controls
Knirsch, 1974 57 males received 0, 35 or 75 g/day PDX for 2 weeks Two cases of mild diarrhea in 35 g/day group. PDX well tolerated in this study
Pfizer Central Res., No diarrhea in 75 g/day group. More G.I.
Groton, CT symptoms at 75 g/day

M.T. Flood et al. / Food and Chemical Toxicology 42 (2004) 1531–1542

Raphan, 1975a 21 males and females received increasing doses of Mean laxation threshold 88 g/person for Supports maximum tolerated dose of 50 g for PDX. Several
Pfizer Central Res., placebo, sorbitol, and PDX. Doses discontinued at PDX, 71 g/person for sorbitol; maximum participants had no laxation at 130 g
Groton, CT pre-established laxation endpoint. PDX doses were tolerated doses for PDX varied from 50 to
40–130 g/day 130 g
Raphan, 1975b 38 males and females received 30 g PDX/day for 5 21 incidences of ‘‘changed stool conditions’’, Not designed to determine tolerance limits. Doses were adjusted
Pfizer Central Res., weeks, 45 g/day for 3 weeks, 60 g/day for 4 weeks. softening to diarrhea vs. 6 incidences in to minimize symptoms
Groton, CT 13 controls controls
Bunde, 1975 4 week study. 108 children and adolescents, ages 2– Some episodes of diarrhea, but isolated and Despite large number of participants in study, only relatively
Hill Top Research, 16, divided into groups according to age, received transient. Overall, 36 episodes out of 1,596 small numbers in given age groups received PDX. Data support
Miamiville, OH placebo or PDX at 500 mg/kg bw during week one, subject days. Diarrhea more frequent in 2–3 conclusion from other studies that on a unit weight basis, children
750 mg/kg bw during week two and 1000 mg/kg bw year age group––16 episodes out of 308 are no more sensitive to low digestible carbohydrates than are
during weeks 3–4. 11 children aged 2–3 received subject days. No episodes of diarrhea in adults. Zero incidence of diarrhea in placebo group is surprising
PDX placebo group
McMahon, 1974 Fasted 10 male and female diabetics received 50 g No diarrhea observed Not designed as laxation study. Supports maximum tolerated
Tulane Univ. School slug dose PDX with varying amounts of glucose dose of 50 g. Single dose administered to fasted subjects
of Medicine, represents worst case ingestion scenario
New Orleans, LA
Scrimshaw and 10 males and females received 30 g/day PDX during No significant increase in diarrhea vs. controls Supports maximum tolerated dose of 50 g. Small number of
Young, 1977; the first week, 40 g/day the second week, and 50 participants. A metabolic balance study
Dept. of Nutrition and g/day for the following 3 weeks. 6 control subjects
Food Science,
Mass. Institute of
Technology,
Cambridge, MA
Beer, 1989 24 fasted adult males received, on different days, 0, No laxation observed Supports maximum tolerated dose of greater than 50 g
Univ. Texas 1, 2, 3 and 4 candy bars containing 14.4 g PDX each
Health Science Center,
San Antonio, TX
Curtis, 1991 160 females received 1, 2, 3 or 4 confections each No significant increase in diarrhea vs. controls Supports maximum tolerated dose of greater than 40 g for
Harris Labs, containing 10.1 g PDX. 40 received placebo females
Lincoln, NE
 M.T. Flood et al. / Food and Chemical Toxicology 42 (2004) 1531–1542
recorded included peak time, peak level, area under
the curve (AUC), and area above baseline level.
Parameters in test groups 1–2 and 3–4 were compared
by t-tests.
7. Scrimshaw and Young (1977). In a double-blind met-
abolic balance study, 16 healthy young adult male
and female subjects, ages 18–23, received either a con-
trol diet containing sucrose and fat or polydextrose
for a total of 8 weeks. The first 2 weeks of the study
served as a baseline period. During the third week, 10
participants received 30 g/day polydextrose in ice
cream, orange juice, and gelatin dessert. The dosage
was raised to 40 g/day during the fourth week and
to 50 g/day during weeks 5–8. The remaining six sub-
jects served as the control group.
Blood measurements included complete blood count
(CBC) with differential and platelet count, and serum
was analyzed for urea nitrogen (BUN), uric acid,
cholesterol, total protein, albumin, transaminase
(SGOT and SGPT), lactic dehydrogenase, alkaline
phosphatase, inorganic phosphorous, calcium, total
bilirubin, triglycerides, chloride, iron, transferrin,
potassium, sodium, zinc, vitamin A, carotene, vitamin
E, vitamin C, folic acid, glucose, and prothrombin
time (the latter at termination). Urine analysis in-
cluded total nitrogen, calcium, sodium, potassium,
zinc, riboflavin, thiamin and creatinine. Fecal deter-
minations included total nitrogen, total fat, calcium,
potassium, sodium, iron, zinc and moisture. Mean
urine and fecal calcium, sodium, potassium, iron,
nitrogen, and zinc were compared to dietary intake to
determine nutrient balance. Data were evaluated
through analysis of variance and covariance.
8. Beer (1989). In a double-blind, randomized study, 24
fasted adult males, ages 21–32, received 1–4 candy
bars containing 0 or 14.4 g polydextrose per bar.
All subjects received 1, 2, 3 and 4 bars containing
polydextrose or corresponding controls (sucrose +
corn syrup) (eight tests per subject). Breath samples
were analyzed for hydrogen (breath hydrogen re-
sponse, BHR) before, during, and 8 h after ingestion
of the test substance. Lactulose (10 g in 15 ml), which
is completely non-digested in the small intestine, was
ingested as a reference for BHR by all subjects in a
baseline study prior to the candy bar study.
Two-way analysis of variance was used for all breath
hydrogen parameters to determine the effect of time,
dose, and product. Chi-square analysis was per-
formed for all subjective responses of symptoms
occurring at the time of peak BHR.
9. Curtis (1991). In a blind, two-way crossover study,
200 females, ages 19–50, divided into 10 parallel
groups, received confections containing polydextrose
and caprenin (a triglyceride containing caprylic, cap-
ric, and behenic acids), a conventional sweetener and
fat, or a conventional sweetener and caprenin. Partic-
1537
ipants in eight groups received 1, 2, 3, or 4 confec-
tions, at one hour intervals, each containing
caprenin and 10.1 g polydextrose or the conventional
sweetener and fat. Symptoms were noted over a 3-day
period, after which time the study was repeated with
the crossover diet. In the remaining two groups, ca-
prenin and the conventional sweetener were com-
pared to the conventional sweetener and fat.
Each subject was asked to evaluate a series of possible
gastrointestinal symptoms and their intensity at 24,
48, and 72 h after treatment. These included gas/wind,
bloating, heartburn, overall feeling, belching, cramp-
ing/abdominal gas, nausea, urgency, and diarrhea.
Statistical analyses were performed with the SAS
system Version 6.03 or 6.04. Symptoms in those
receiving polydextrose were evaluated relative to those
receiving placebos by crossover analysis of variance.
4. Results
Protocols and results are summarized in Table 2.
1. Alter (1974). Eleven out of 20 participants from the
polydextrose group were dropped because of diar-
rhea, five during the first week, three during the sec-
ond week, and three during the last week. Five out
of nine participants from the placebo group were
dropped because of diarrhea, all at the end of the
third week. Overall, gastrointestinal symptoms in
the polydextrose group were higher than in the pla-
cebo group. Mean lipids and nitrogen in feces did
not differ significantly between the placebo and poly-
dextrose group. Mean percentage hydration, potas-
sium, calcium, and pH declined during the first
week of treatment, but the declines were not signifi-
cant after the second week of treatment. There were
no significant differences in mean transit times, but
individual variability within treatment groups was
very high. Because of the high dropout rate, the sig-
nificance of the results is questionable.
The author concluded that polydextrose was not well
tolerated; but because about the same percentage of
participants receiving the placebo were dropped due
to diarrhea, it is possible that the milk drink may
have contributed to the symptoms.
2. Knirsch (1974). All subjects completed the study and
polydextrose was generally well tolerated. Two cases
of mild diarrhea were observed in the groups receiv-
ing 35 g/day, but no cases were observed at 75 g/
day. In general, softer stools and increased flatus were
observed in the 35 g/day group relative to the con-
trols. More frequent symptoms appeared at 75 g/day.
3. Raphan (1975a). Maximum tolerated daily doses
for polydextrose varied from 50 to 130 g. Maximum
tolerated daily doses for sorbitol varied from 30 to
1538 M.T. Flood et al. / Food and Chemical Toxicology 42 (2004) 1531–1542
110 g. Tolerance to both substances was a function of
body weight. The mean laxative threshold was found
to be 1.3 g/kg bw (90 g/person) for polydextrose and
1.0 kg bw (70 g/person) for sorbitol.
Four of the volunteers on polydextrose and seven on
sorbitol requested dose discontinuance before expe-
riencing a laxative effect. The major reported reasons
were flatulence and cramping. The mean threshold
dose for these effects was 90 g/day for the polydextrose
group and 67 g/day for the sorbitol group. These doses
approximate the mean respective doses for laxative
effects, even though the reasons for intolerance were
different. Two subjects tolerated the maximum dose of
polydextrose (130 g/day), and one of these also tol-
erated the maximum dose of sorbitol (110 g/day).
About 70% of the volunteers reached the laxative ef-
fect endpoint without requesting that the doses be
discontinued, implying that they possibly could have
‘‘tolerated’’ doses at higher doses. No diarrhea was
reported by any of the subjects during this study.
4. Raphan (1975b). A total of 21 instances of ‘‘changed
stool conditions,’’ from softening to diarrhea, were
observed in the polydextrose groups, versus six inci-
dences in the placebo control. Based on the number
of participants, the percentage of ‘‘changed stool con-
ditions’’ was only slightly higher in the treated
groups. Gastrointestinal side effects were described
as ‘‘mild’’. A small decrease in mean body weight in
the polydextrose group of about 0.1 lb/wk was signif-
icant ðp 6 0:05Þ. There was no significant difference in
transit times, hematology, clinical chemistry, or uri-
nalysis parameters between the polydextrose group
and the control group.
5. Bunde (1975). Two subjects (one placebo, one poly-
dextrose) failed to complete the study for reasons
unrelated to gastrointestinal symptoms. Episodes of
diarrhea occurred in the polydextrose groups, but
the occurrences were isolated and transient. Inci-
dences of diarrhea were lower in the higher age
group, and there was no dose dependence. In the 2–
3 year age group, six out of 11 subjects experienced
one or more episodes of diarrhea over the 4-week test
period. In this age group, there were 16 episodes out
of 308 subject days. However, in every age group,
diarrhea was transient (occurred on a single day) in
virtually all cases and disappeared spontaneously
although administration of polydextrose was contin-
ued. Overall, there were 36 episodes out of 1596 sub-
ject days. Flatulence was the only side effect persisting
more than 2 days that was determined to be statisti-
cally significant. There were no abnormalities in
blood or urine chemistries.
6. McMahon (1974). All participants completed the
study and the greatest reporting of side effects was
with the administration of 100 g glucose. Diarrhea
was noted on six occasions: 100 g glucose (1), 100 g
glucose + 50 g polydextrose (2), 50 g glucose (1), 50
g glucose + 50 g polydextrose (1), and 50 g polydext-
rose (1). Considering the high dose, and the fact that
the subjects consumed the test solution on an empty
stomach, polydextrose was judged to be well toler-
ated.
7. Scrimshaw and Young (1977). During the fourth
week, one subject receiving polydextrose requested
and received medication for watery stools. After 2
days, medication was discontinued and the subject
completed the study. One of the subjects receiving
the control diet had episodes of watery stools on days
3, 14, 15, and 16 of the study. Increased flatulence
and softer stools were generally experienced in the
treated group. Stool weight and moisture increased
in the treated group, as expected. Hematological
and clinical chemistry parameters did not show any
treatment related effects, including electrolytes and
vitamins. Metabolic balance studies revealed no dif-
ferences in utilization of calcium, sodium, potassium,
iron, zinc, or nitrogen between those receiving poly-
dextrose and those receiving the control diet. The ab-
sence of detectible changes in nutrient utilization led
to the conclusion that polydextrose can be ingested
and tolerated without any untoward metabolic and
nutritional consequences in healthy adult subjects.
No diarrhea was reported by any of the subjects dur-
ing this study.
8. Beer (1989). An increase in flatus was observed in the
group receiving the highest polydextrose dose (58 g),
but the increase was not significant. Breath hydrogen
increased to a maximum about 180 min after inges-
tion of 2, 3, or 4 bars containing polydextrose. Breath
hydrogen from those receiving 1 bar was not different
from those receiving the control bars. No diarrhea
was reported.
9. Curtis (1991). All 200 participants completed the
study. A higher level of flatulence was the only statis-
tically significant difference between the polydextrose
groups and the controls when 3 or fewer bars were
consumed. Additional side effects, such as bloating
and urgency, were observed relative to the controls
in groups receiving 4 bars. There were no significant
differences between groups receiving polydextrose
and the control groups in belching, loose stools, or
diarrhea. In the fifth group, there were no significant
differences in side effects between those receiving con-
fections containing caprenin and those receiving the
conventional confections.
5. Published studies on polydextrose relevant to laxation
Three studies have been published in which laxation
was one of the principal endpoints:
 M.T. Flood et al. / Food and Chemical Toxicology 42 (2004) 1531–1542
1. Zhong et al. (2000). In this double-blind study, 120
healthy men and women were randomly assigned to
one of four groups, receiving 0, 4, 8, or 12 g of poly-
dextrose in 100 ml water for 28 days. Physiologic
functions recorded included frequency and ease of
defecation, abdominal distension, abdominal cramps,
diarrhea, and various hypoglycemic symptoms. Each
symptom was numerically rated on a predetermined
scale.
Fecal weights increased, as did frequency and ease of
defecation, but there were no reports of abdominal
cramps, diarrhea, or adverse hypoglycemic symp-
toms. No significant change was observed in blood
lipids, a result that was expected due to the low fat
content of the Chinese diet consumed by the partici-
pants. Similar to effects observed from other dietary
fibers, populations of Bacteroides species decreased in
the feces, whereas Lactobacillus and Bifidobacterium
species increased in all groups receiving polydextrose.
2. Nakagawa et al. (1990). In a Latin Square crossover
designed study, 22 adolescent females received bever-
ages containing 0, 5, 7, or 10 g polydextrose.
Although stools became softer, the frequency and
feeling of defecation were unaffected by polydextrose
intake.
3. Tomlin and Read (1988). Twelve healthy male volun-
teers received 30 g polydextrose daily with or without
an additional 2 g ispaghula husk, or 7 g/day ispaghula
in 3 divided doses for 10 days. In a second experiment
12 males received 10 g polydextrose and 2 g ispaghula
per day for 10 days. During the 10-day test periods,
subjects kept a diary of the time of defecation, the
form and consistency of their stools (by comparison
with a set of standard photographs and descriptions),
the time of any episodes of flatulence (second study
only), and any subjective symptoms.
Stool consistency was softer in the subjects receiving
30 g, but not those receiving 10 g. Transit time and
defecation frequency were not affected in either study.
Diarrhea was not mentioned as a result. In this study,
stools softening was considered a desirable result.
An additional three published studies were designed
to measure endpoints other than laxation:
1. Achour et al. (1994). In a study designed to measure
the energy value of polydextrose, seven healthy male
volunteers received 30 g of polydextrose daily, in 3 di-
vided doses with meals, for 30 days after an initial 8
day control period. Fecal weight tended to increase
when polydextrose was ingested, but none of the vol-
unteers experienced adverse symptoms.
2. Endo et al. (1991). In a crossover design, eight
healthy volunteers received a low cholesterol diet, a
high cholesterol diet, and a high cholesterol diet sup-
plemented with 15 g polydextrose daily at consecutive
1539
2 week intervals. Polydextrose supplementation in-
creased fecal weight and decreased fecal pH. Stool
water content remained unchanged, an indication
that diarrhea did not occur, although this was not
stated explicitly. A significant reduction of Clostrid-
ium species in feces was observed after ingestion of
polydextrose. No significant differences were ob-
served in Lactobacillus or Bifidobacterium species.
3. Saku et al. (1991). In a study designed to measure the
effects of polydextrose on serum lipids, lipoproteins,
and apolipoproteins, 61 healthy volunteers received
15 g/d polydextrose in 3 doses for 2 months. Soft
stools or diarrhea were reported by 56% of the sub-
jects during the first month and by 53% during the
second month. Two subjects stopped taking poly-
dextrose during the first month of treatment because
of diarrhea.
In this paper, diarrhea was not defined. The category
‘‘loose stools and diarrhea’’ is broad and could well
include desirable laxation effects. This is the only
study, other than the study on children by Bunde
(1975), in which diarrhea was reported at such a low
dose. Because the study was not designed as a laxa-
tion study, and a detailed description of the reported
laxative effects is lacking, this study is not considered
useful in establishing a laxative threshold.
6. Discussion
Results from these studies support a mean laxative
threshold of about 90 g/day for adults (1.3 g/kg bw/day)
or 50 g (0.7 g/kg bw) as a single dose, as concluded by
JECFA (1987) and the EC/SCF (1990). Therefore, the
practical no-effect dose for polydextrose is about 50 g/
day (0.7 g/kg bw). These values are probably conserva-
tive because of the study methodologies (discussed
above) and time limitations of the studies.
The mean laxation threshold for sorbitol, found by
Raphan (1975a) to be 70 g/day, agrees very well with the
value of 71 g/day estimated by Patil et al. (1987). Be-
cause of its much higher average molecular weight, it is
not surprising that polydextrose has a higher mean
laxation threshold than sorbitol (affirmed GRAS under
21 CFR 184.1835). Tolerance to polydextrose also
compares favorably to that of fructo-oligosaccharide,
oligofructose, and inulin, for which the minimum laxa-
tive threshold is 20–30 g/day (Carabin and Flamm,
1999; Briet et al., 1995; Coussement, 1999), and D -tag-
atose, for which the minimum laxative threshold is 20–
30 g/day (Storey and Lee, 1999; Buemann et al., 1999).
Fructo-oligosaccharide, D -tagatose, and inulin have
successfully completed FDA’s GRAS notification pro-
cess (GRN 44, 78, and 118, respectively).
A few episodes of diarrhea did occur in the Bunde
study (1975) in children, but the effects were isolated and
1540 M.T. Flood et al. / Food and Chemical Toxicology 42 (2004) 1531–1542
transient, and no subject withdrew because of laxation
symptoms. A weakness of this study is the relatively few
participants in any single dose group. Although 108
children participated in the study, only 11–12 subjects in
a given age group received polydextrose.
There are controlled studies in which children (over 5
€
years of age) received polyols (Akerblom et al., 1981;
Uhari et al., 1996; Paige et al., 1992; Storey et al., 2002;
Carabin and Flamm, 1999). Since the diarrhea induced
by polyols is the same type of diarrhea induced by
polydextrose (i.e., osmotic diarrhea), the results are di-
rectly relevant to polydextrose. Taken in aggregate, the
studies demonstrate that children are no more sensitive
to polyols than are adults when the doses are adminis-
tered on a body weight basis.
There is evidence that children under 5 years of age
are more sensitive to certain carbohydrates. It is known
that ingestion of fruit juices, such as apple or pear juice,
is one cause of chronic non-specific diarrhea (CNSD)
(Ament, 1996; Nobigrot et al., 1997; Kneepkens et al.,
1989). More than 90% of cases of CNSD spontaneously
resolve by the time the patient is 39 months of age
(Ament, 1996). There is some dispute whether the
compound primarily responsible for diarrhea from fruit
juices is fructose or sorbitol, but there is agreement that
both substances may contribute to diarrhea. The in-
creased incidence of diarrhea arising from reduced
absorption of a substance in the small intestine of chil-
dren relative to adults would not be directly relevant
to the gastrointestinal effects of polydextrose because
polydextrose is almost completely unabsorbed in the
small intestine of adults as well as in children. Factors
that might increase diarrhea in susceptible infants from
a substance not digested in the small intestine would be
reduced transit times and incompletely developed co-
lonic flora.
Therefore, the polydextrose data are consistent with
results observed with other low digestible carbohy-
drates. On a body weight basis, children are no more
sensitive to low digestible carbohydrates than are adults.
FDA reached a similar conclusion in its evaluation of
olestra, a non-caloric fat substitute (FDA, 1996).
7. Conclusion
The studies reviewed in this article demonstrate that
polydextrose is not likely to induce diarrhea in adults at
doses less than 50 g per day (a practical no-effect dose),
and most individuals may only experience diarrhea from
much higher doses. The diarrhea induced by polydext-
rose is isolated and transient. Clinical chemistry and
metabolic balance studies have shown no treatment re-
lated effect from ingestion of high doses of polydextrose.
The mean laxative threshold dose for polydextrose (
90
g/d; 1.3 g/kg bw) is higher than corresponding doses of
almost all low caloric carbohydrates in commercial use.
The potential for diarrhea arising from use of poly-
dextrose is low, and there should be no safety concern
over occasional episodes of diarrhea that may arise from
consumption of large amounts of this substance.
Acknowledgements
The authors are grateful for the excellent work of the
eight investigators whose studies are described herein
(see Tables 2 and 3). We also acknowledge the kind
assistance of Dr. Nino Binns of McNeil Specialties
(formerly of Pfizer Central Research) and Dr. Randall
Buddington of Mississippi State University for their
contributions, and Dr. James Heimbach and Dr. George
Burdock for their review of the manuscript.
Names of the principal investigators and and ad-
dresses of the institutions where the work was done:
Study 1: Dr. Sheldon Alter, Pfizer Central Research,
Eastern Point Road, Groton, CT 06340; Study 2: Dr.
Anthony K. Knirsch, Pfizer Central Research, Eastern
Point Road, Groton, CT 06340; Studies 3 and 4: Dr.
Harvey Raphan, Pfizer Central Research, Eastern Point
Road, Groton, CT 06340; Study 5: Dr. Carl A. Bunde,
Hill Top Research, Miamiville, OH 45147; Study 6: Dr.
F. Gilbert McMahon, Tulane University School of
Medicine, 1430 Tulane Avenue, New Orleans, LA
70118; Study 7: Drs. Nevin S. Scrimshaw and Vernon R.
Young, Department of Nutrition and Food Science,
Massachusetts Institute of Technology, 77 Massachu-
setts Avenue, Cambridge, MA 02139; Study 8: Dr.
William H. Beer, University of Texas Health Sciences
Center, San Antonio, TX; Study 9: Dr. Gary L. Curtis,
Harris Laboratories, Inc., 624 Peach Street, Lincoln, NE
68501.
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