Table 1 Baseline characteristics of study population mean 9 S.D.
Supplementation group Half-dose
Placebo Full-dose
99 Malesfemales n
710 106
53.4 9 8.9 51.6 9 8.1
50.2 9 8.3 Age years
77.8 9 10.2 Weight kg
76.9 9 17.7 76.3 9 12.1
Body mass index 26.9 9 2.8
26.0 9 4.2 25.4 9 3.6
kgm
2
Dietary composition
a
Total energyday 1960 9 490
1840 9 375 2075 9 600
Kcal 26.6 9 8.6
Total fat 26.4 9 7.4
27.0 9 7.5 energy
8.5 9 4.3 Saturated fat
8.4 9 3.1 8.1 9 3.1
energy 11.3 9 6.1
Dietary fiber 11.6 9 3.7
11.9 9 4.4 g1000 Kcal
2.2 9 3.1 4.7 9 4.8
Alcohol 2.6 9 2.9
energy 19.9 9 15.7
25.0 9 23.1 Physical activity
22.2 9 18.2 score
b
Outcome measures Total-C mgdl
230 9 24 231 9 21
235 9 27 151 9 18
158 9 20 163 9 18
LDL-C mgdl 46 9 10
HDL-C mgdl 54 9 18
46 9 12 133 9 48
125 9 63 126 9 56
Triacylglycerol mgdl
Blood pressure mmHg
Systolic 115.0 9 11.0
117.0 9 11.9 118.1 9 14.5
74.9 9 7.8 79.1 9 7.3
75.8 9 7.6 Diastolic
a
Does not include participants with missing baseline or end-study food records placebo n = 3, half-dose n = 1, full-dose n = 1.
b
Includes combined hours per week of light to moderate and intense physical activity, at work or leisure examples provided in
methods. None of the between-group differences were statistically significant
at baseline.
completed nutrition study unpublished to predict the S.D. of pre-post change in LDL-C concentrations 16
mgdl, the study was designed to have a power of 80 1 − b to detect a 10 difference in 12-week LDL-C
change between treatment arms a = 0.05.
3. Results
Table 1 shows the three groups were similar at baseline in age, weight, diet composition, plasma lipids
and blood pressure. Fifty-one participants completed the study. Two participants dropped out in the first
week because of unforeseen scheduling conflicts, one each from the half-dose and full-dose groups.
Minimal side effects were reported. Of the 12 symp- toms enumerated in the questionnaire, participants re-
ported seldom to occasional incidences of belching, body odor, stomach gas, flatulence and constipation.
Eleven, 47 and 24 of the placebo, half-dose and full dose group, respectively, reported at least one of these
gastrointestinal symptoms. However, the symptoms were mild in severity and did not impair participation
or study adherence. The blinding technique proved to be effective. The study tablets were indistinguishable by
sight and smell. Twenty-eight percent of the placebo group, 27 of the half-dose and 0 of the full-dose
group correctly guessed their assigned dose.
Weight, dietary composition, physical activity, and study adherence remained constant throughout the
study. The differences between groups for these poten- tial confounders were modest and not statistically sig-
nificant. The average difference from baseline in weight was less than 1 kg for each group at each clinic visit,
and at end-study the differences from baseline mean 9 S.D. were + 0.4 9 1.6, 0.0 9 1.6 and + 0.8 9 1.6 kg
for placebo, half-dose and full-dose, respectively. The change from baseline in energy from saturated fat
was determined at both mid-study and end-study to be: +
0.1 9 3.0 and + 0.8 9 3.6 respectively, for placebo n = 15 with complete data; + 1.8 9 3.7 and + 2.6 9
3.1 for half-dose n = 16 with complete data; and +
1.8 9 2.4 and + 1.4 9 3.5 for full-dose n = 14 with complete data. The change from baseline in mean
activity scores exercise plus physical activity at mid- study and end-study was: − 2.6 9 14.3 and + 2.3 9 8.4
hweek, respectively, for placebo; − 5.8 9 16.8 and −
5.3 9 12.0 hweek for half-dose; and + 0.5 9 11.0 and + 1.9 9 7.8 hweek for full-dose complete data for
all but placebo with n = 1 missing. Study adherence as assessed separately by tablet count and by a self-admin-
istered questionnaire was ] 92 across all treatment groups.
Plasma lipid changes are presented in Fig. 2 as group averages, and the LDL-C change data from each indi-
vidual participant are presented in Fig. 3. Mean
Fig. 2. Mean 9 S.E.M. 12-week changes in plasma lipids. Analysis of covariance detected no significant between-group differences.
ences in slopes in a GLM using ANOCOVA with adjustment for baseline lipid level as a covariate. All
statistical tests were two-tailed using a significance level a of 0.05. Using empirical data from a previously
Fig. 3. Individual and mean 12-week changes in low density lipo- protein cholesterol LDL-C by treatment group.
statistical approach was used to test for differences in the slopes of the 12-week changes. Again, no statisti-
cally significant differences in lipid changes were de- tected.
For placebo,
half-dose and
full-dose, respectively, the slopes mgdl per day were: total-C,
− 0.04 9 0.39, 0.03 9 0.28 and − 0.11 9 0.32; LDL-C,
− 0.02 9 0.27, 0.03 9 0.25 and − 0.07 9 0.41; HDL-C,
0.02 9 0.07, 0.03 9 0.06 and 0.03 9 0.08; and triacyl- glycerols, − 0.14 9 0.52, 0.03 9 0.44 and − 0.10 9 0.42.
Results of the 0, 2, 4, 6, 8, 10 and 12-week plasma lipid assessments are presented in Table 2. There were no
significant between-group differences in blood pressure during the study in this normotensive population data
not presented.
4. Discussion
