Lipid-altering effects of a dietary supplement tablet containing free plant sterols and stanols in men and women with primary hypercholesterolaemia: a randomized, placebo-controlled crossover trial

Figures & data

Figure 1.  Participant flow through the study.

Table I.  Subject characteristics at baseline.^*

Characteristic	Total N = 32
	n (%)
Male	13 (41)
Female	19 (59)
Race/ethnicity
Non-Hispanic White	29 (91)
Asian	2 (6)
Black/African-American	1 (3)
Smoking status
Non-smoker	29 (91)
Current smoker	3 (9)
	Mean ± SEM
Age (years)	57.6 ± 2.1
Weight (kg)	77.4 ± 2.5
Body mass index (kg/m^2)	27.4 ± 0.7
Systolic blood pressure (mm Hg)	119.5 ± 1.9
Diastolic blood pressure (mm Hg)	73.7 ± 1.5
Fasting glucose (mmol/l)^†	5.23 ± 0.11

Note: SEM, standard error of the mean

^* Results for both treatment sequences were pooled

^† To convert glucose from mmol/l to mg/dl, multiply by 18.

Table II.  Fasting lipids at baseline, percent changes from baseline and differences in responses between treatments.^*,†

Parameter	Baseline (mmol/l)^‡	Control (%Δ)	Active (%Δ)	% difference in response	p-Value
	Mean (SEM) or mean
LDL-C	4.02 (0.08)	0.6 (1.4)	− 4.3 (1.9)	− 4.9	0.002
Non-HDL-C	4.71 (0.09)	− 1.4 (1.2)	− 5.0 (1.5)	− 3.6	0.008
TC	5.88 (0.08)	− 0.5 (1.1)	− 3.3 (1.3)	− 2.8	0.024
HDL-C	1.17 (0.06)	3.8 (1.8)	4.1 (2.4)	0.3	0.889
TG	1.51 (0.12)	− 8.4 (4.1)	− 4.2 (4.6)	4.2	0.281

Notes: HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; SEM, standard error of the mean; TC, total cholesterol; TG, triglycerides

^* Results for both treatment sequences were pooled. Adjusting for differences in dietary intake did not significantly alter results

^† Baseline = average of values at weeks − 1 and 0; control and active, %Δ = percentage change from baseline to the average of values at the last 2 weeks of each treatment period (weeks 5 and 6, weeks 11 and 12); difference in response = active % change − control % change

^‡ To convert from mmol/l to mg/dl, for cholesterol multiply by 38.7 and for TG multiply by 88.6.