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Biochemistry Department, Walsall NHS Trust, The Manor Hospital, Walsall WS2 9PS, UK;
and **School of Applied Sciences, University of Wolverhampton, Wolverhampton WV1 1SB, UK
KEY WORDS:
plasma lipids
antioxidants
gender
garlic
ABSTRACT Early trials of garlic preparations on blood lipids mainly supported a lipid-lowering effect, whereas later
well-designed garlic tablet trials were mainly entirely null. However, enteric simulation tests suggest that this discordance may result from ineffective delivery of bioactive agents from the brands of garlic powder (GP) and cyclodextrinbound garlic oil (GO) tablets tested in some recent negative trials. In contrast, enteric simulation tests show that the
preformed bioactive agents present in traditional gelatin capsules of GO are efficiently released, although such
capsules have rarely been investigated in lipid-lowering trials. It was hypothesized that gelatin capsules of GO given to
normal subjects would improve specified coronary heart disease risk factors. Effects of a GP preparation were also
investigated. Subjects (n 51; men and women, mean age 27 y) were randomly assigned to receive either 8.2 mg/d of
GO (allyl sulfides) or placebo for 11 wk. Another 27 subjects received garlic powder (GP) of similar biopotential (7.8 mg
allicin/d). Outcome measures were 95% confidence intervals (CI) between GO and placebo groups for differences
between baseline and subsequent sample times. Men and women combined showed no significant differences save for
an improved total antioxidant capacity at 6 wk (P 0.01). Hence, no benefit from GO after 11 wk is one plausible
conclusion. However, there were significant differences in effect of GO between men and women for HDL cholesterol
(HDL-C) (P 0.004) and total cholesterol (TC)/HDL-C (P 0.003). Women showed favorable effects in terms of CHD
risk factors (i.e., increases in HDL-C and reductions in TC/HDL-C), whereas men had small adverse effects. There was
a significant difference in the GO effect for glucose (P 0.006), with a reduction seen for men and an increase for
women. The gender effects were unexpected and such analyses were not planned in advance. Confirmation of these
findings with larger numbers of subjects would have importance for the use of garlic against CHD and for the design of
future garlic studies. J. Nutr. 131: 14711478, 2001.
1
Presented in part in abstract form at the XXIII Annual Conference, Association
of Clinical Biochemists, 2730 December 1996, Kottayam, India [Maslin, D. J. &
Zhang X.-H. (1996) The effects of garlic oil upon the plasma lipid profile of healthy
humans. Abs. 006, p. 5] and [Zhang X.-H., Maxwell, S.R.J., Thorpe, G.H.G., Thomason, H., Rea, C. A., Connock, M. J. & Maslin, D. J. (1997) The action of garlic oil
upon plasma total antioxidant capacity. Biochem. Soc. Trans. 25: 523s (abs.)].
2
Doses and funding from Seven Seas, Limited (UK) and from BioCare Limited
(UK).
3
See NAPS document No. 05595 for two pages of supplementary material.
This is not a multi-article document. Order from NAPS c/o Microfiche Publications, 248 Hempstead Turnpike, West Hempstead, New York 11552. Remit in
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4
To whom correspondence should be addressed.
E-mail: D.Maslin@wlv.ac.uk.
5
Abbreviations used: AMPK, AMP-dependent kinase; CHD, coronary heart
disease; CI, confidence interval; GO, garlic oil; GP, garlic powder; HDL-C, HDL
cholesterol; HMGR, hydroxy-methyl-CoA-reductase; HRT, hormone-replacement
therapy; LDL-C, LDL cholesterol; TAOC, total antioxidant capacity; TC, total
cholesterol; TG, triglycerides.
1472
ZHANG ET AL.
statistical analysis. The distributions of age and triglyceride measurements were skewed; thus, the median and interquartile range were
used to describe these.
The main outcomes concerned the changes in plasma values from
the beginning to the end of the 11-wk treatment period. Mean
changes in plasma for subjects receiving GO were compared with
those for subjects receiving placebo by the use of 95% confidence
intervals (CI) and by two-sample t tests with probability values
considered significant at P 0.05.
Subgroup analyses by gender, age and body weight were not
specified in advance of analysis. For this reason and because many t
tests for interaction were done, statistical significance was set at P
0.01; accordingly, care should be taken in the interpretation of results
of borderline significance. The t tests of garlic effect by gender
interaction were done according to the method described by Pocock
(55). Gender differences in the effect of garlic were computed with
95% CI. Similar analyses were done for age and body weight groups
defined by the median cut-off points for all subjects in the randomized
trial.
RESULTS
Seventy-eight volunteers were recruited into the study.
Fifty-one of these were entered into the randomized trial to
compare GO and placebo, and 27 were recruited separately to
receive GP.
An overview of recruitment, loss to follow-up and key
stages of data collection and follow-up is given in Figure 1.
Sixty subjects (GO, 19/25; placebo, 21/26; GP, 20/27)
remained in the study to the end of the 11-wk treatment
period. In terms of measured baseline characteristics, those lost
to follow-up were not dissimilar from those who remained
(Table 1).
1473
FIGURE 1 Study profile showing recruitment and losses of subjects, treatment duration and blood sampling times throughout the trial.
ZHANG ET AL.
1474
TABLE 1
Baseline characteristics of subjects completing treatment
and those lost to follow-up at the end of treatment1,2
Lost to follow-up in GO
and placebo groups
No
Yes
Lost to follow-up in GP
group
No
Yes
n
40
11
20
7
Men, %
50
55
35
14
TC, mmol/L
4.9 0.8
5.1 0.7
4.3 0.9
5.4 1.8
HDL-C, mmol/L 1.30 0.26 1.21 0.22 1.18 0.22 1.38 0.24
TC/HDL-C
3.9 1.0
4.4 1.2
3.8 0.9
4.0 1.2
LDL-C, mmol/L
3.1 0.8
3.3 0.7
2.8 0.8
3.5 1.5
TG, mmol/L
1.07 0.50 1.19 0.39 0.86 0.36 1.21 0.45
Glucose, mmol/L 5.0 0.5
5.1 0.3
5.1 0.4
5.1 0.3
1 Data are means SD.
2 Abbreviations used: GO, garlic oil; GP, garlic powder; HDL-C, HDL
TABLE 2
n
Men, %
Age, y
Body weight, kg
TC, mmol/L
HDL-C, mmol/L
TC/HDL-C
LDL-C, mmol/L
TG, mmol/L
Glucose, mmol/L
TAOC, mmol Trolox
equiv/L
GO group
Placebo
group
GP group
19
58
24 7
22 (2023)3
71 16
4.8 0.9
1.28 0.25
3.9 1.1
3.0 0.9
1.19 0.62
1.0 (0.81.4)3
5.1 0.3
21
43
29 9
27 (2133)
70 14
4.9 0.7
1.32 0.28
3.9 0.9
3.1 0.6
0.96 0.34
1.0 (0.61.2)
5.0 0.6
20
35
26 8
23 (2129)
63 10
4.3 0.9
1.18 0.22
3.8 0.9
2.8 0.8
0.86 0.36
0.8 (0.61.1)
5.1 0.4
372 75
413 78
366 92
1475
TABLE 3
Effects of garlic oil (GO) or garlic powder (GP) intake for 11 wk by men and women relative to placebo upon selected
CHD risk factors including plasma lipids, glucose and total antioxidants1
Plasma variable
Change2 in GO group
(n 1819)
TC, mmol/L
HDL-C, mmol/L
TC/HDL-C
LDL-C, mmol/L
TG, mmol/L
Glucose, mmol/L
Change2 in placebo
group (n 1921)
26 (3, 55)
32 (1, 64)
Change2 in GP
group (n 1920)
Garlic powder
effect3
DISCUSSION
The main hypothesis was not supported by statistical tests.
One plausible explanation is that garlic lacks lipid-lowering
efficacy, as was concluded for other recent negative garlic
studies (10,11,13,16,17) and the latest meta-analysis (9). This
conclusion differs from that of earlier meta-analyses (1,6) and
some recent metabolic studies, which indicate a lipid-lowering
action of garlic. For example, inhibition of cholesterol biosynthesis by garlic was observed in rat hepatocytes (56), and garlic
intake by rats produced elevated catecholamine levels associ-
1 Abbreviations used: CHD, coronary heart disease; equiv, equivalent; HDL-C, HDL cholesterol; LDL-C, LDL cholesterol; TAOC, total antioxidant
capacity; TC, total cholesterol; TG, triglycerides.
2 Changes from baseline values at the end of the treatment period (wk 11) were calculated by subtracting the measured values of baseline from
those at 11 wk; therefore a positive figure implies a decrease and a negative figure implies an increase in values, on average, during the treatment
period; data are presented as means (95% confidence intervals).
3 Effects of garlic intake were calculated by subtracting changes from baseline in the placebo group from those in the garlic group; therefore any
favorable effects of garlic were indicated by negative figures for TC, TC/HDL-C, LDL-C and glucose and by positive figures for HDL-C and TAOC;
data are presented as means (95% confidence intervals).
TABLE 4
Influence of gender interaction upon effects of garlic oil (GO) or garlic powder (GP) intake for 11 wk by men and women relative
to placebo on selected CHD risk factors including plasma lipids, glucose and total antioxidants1
Garlic oil
Mean effects2
Plasma variable
TC, mmol/L
HDL-C, mmol/L
TC/HDL-C
LDL-C, mmol/L
TG, mmol/L
Glucose, mmol/L
TAOC, mol Trolox equiv/L
All
Women
Men
(19/21)3 (8/12)3 (11/9)3
0.20
0.03
0.16
0.15
0.18
0.16
6
0.50
0.16
0.94
0.63
0.06
0.16
7
0.11
0.08
0.56
0.29
0.23
0.49
4
Garlic powder
Mean effects2
Gender interaction
Mean (95% CI)4
P5
0.13
0.004
0.003
0.02
0.47
0.006
0.95
All
Women
Men
(20/21)3 (7/9)3 (13/12)3
0.05
0.05
0.18
0.10
0.00
0.04
10
0.22
0.05
0.40
0.28
0.00
0.15
5
0.19
0.05
0.08
0.16
0.03
0.31
35
Gender interaction
Mean (95% CI)4
P5
0.24
0.95
0.30
0.21
0.86
0.07
0.48
1 Abbreviations used: CHD, coronary heart disease; 95% CI, 95% confidence intervals; equiv, equivalent; HDL-C, HDL cholesterol; LDL-C, LDL
cholesterol; TAOC, total antioxidant capacity; TC, total cholesterol; TG, triglycerides.
2 Effects of garlic intake were calculated as for Table 3.
3 Number in garlic group/number in placebo group.
4 Gender interactions on garlic effects were calculated as the mean difference (95% CI) between women and men (women men).
5 P probability value of t test for gender interaction; underlined values indicate significant interaction (P 0.01). Null hypothesis: effect of garlic
on response variable is independent of gender.
ZHANG ET AL.
1476
TABLE 5
Influence of gender interaction on the effects of garlic oil (GO) or garlic powder (GP) intake relative to placebo throughout the trial
upon selected CHD risk factors including plasma lipids, glucose and total antioxidants1,2
Gender interaction upon effects of garlic intake
Plasma variable
TC, mmol/L
HDL-C, mmol/L
TC/HDL-C
LDL-C, mmol/L
TG, mmol/L
Glucose, mmol/L
TAOC, mmol Trolox equiv/L
Type of
garlic intake
4 wk
GO
GP
GO
GP
GO
GP
GO
GP
GO
GP
GO
GP
GO
GP
0.26
0.29
0.01
0.06
0.27
0.00
0.33
0.21
0.17
0.06
0.27
0.03
28
43
6 wk
0.23
0.52
0.09
0.14
0.32
0.25
0.46
0.41
0.33
0.07
0.48
0.80
20
105
11 wk
(end of treatment)
14/15 wk
(postdose 1)
17/18 wk
(postdose 2)
0.60
0.41
0.24
0.00
1.51
0.47
0.92
0.43
0.17
0.03
0.66
0.46
3
40
0.58
0.39
0.07
0.07
0.93
0.72
0.83
0.44
0.39
0.10
0.50
0.34
0
42
0.22
0.43
0.30
0.11
1.18
0.59
0.73
0.59
0.45
0.10
0.41
0.20
26
12
1 Gender interaction upon effects of garlic intake were calculated as for Table 4. Values underlined indicate significant interaction (P 0.01). Null
hypothesis: effect of garlic on response variable is independent of gender.
2 Abbreviations used: CHD, coronary heart disease; equiv, equivalent; HDL-C, HDL cholesterol; LDL-C, LDL cholesterol; TAOC, total antioxidant
capacity; TC, total cholesterol; TG, triglycerides.
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