Isolated soya protein with standardised levels of isoflavones, cotyledon soya fibres and soya phospholipids improves plasma lipids in hypercholesterolaemia: a double-blind, placebo-controlled trial of a yoghurt formulation.
The objective was to study whether a yoghurt containing isolated soya protein with standardised levels of isoflavones, cotyledon soya fibres and soya phospholipids is more effective in lowering total and LDL-cholesterol than a placebo. One hundred and forty-three subjects were randomised to the soya group (n 69) or to the placebo (n 74). The mean baseline levels were 7.6 and 5.1 mmol/l for total and LDL-cholesterol, respectively. Fasting serum lipoproteins were assessed five times during the 8-week intervention period, and 4 weeks thereafter. The results were analysed by a mixed model for unbalanced repeated measurements. During the intervention, there were highly significant differences in lipid-lowering effect in favour of the active soya intervention group compared with the control group. The significant differences were for total cholesterol (estimated mean difference 0.40 mmol/l; P<0.001), LDL-cholesterol (0.39 mmol/l; P<0.001), non-HDL-cholesterol (0.40 mmol/l; P<0.001) and for the total:HDL-cholesterol ratio (0.23; P=0.005). There was no difference in the effects on HDL-cholesterol, triacylglycerols or homocysteine. The lipid-lowering effect occurred within 1-2 weeks of intervention, and was not due to weight loss. The safety profile for active soya was similar to the placebo group, except for gastrointestinal symptoms, which caused a significantly higher dropout rate (fourteen v. three subjects) among the subjects taking active soya.
National Public Health Institute, Mannerheimintie 166, FIN-00300 Helsinki, Finland. pekka.puska@ktl.fi
Pekka
P
Puska
Vesa
V
Korpelainen
Lars H
LH
Høie
Eva
E
Skovlund
Knut T
KT
Smerud
D000328:Adult; D000368:Aged; D001794:Blood Pressure / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D018548:Cotyledon; D004043:Dietary Fiber / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000178:diet therapy* / Q000503:physiopathology; D007529:Isoflavones / Q000008:administration & dosage; D008055:Lipids / Q000097:blood*; D008297:Male; D008875:Middle Aged; D010743:Phospholipids / Q000008:administration & dosage; D030262:Soybean Proteins / Q000627:therapeutic use*; D015014:Yogurt
D004043:Dietary Fiber; D007529:Isoflavones; D008055:Lipids; D010743:Phospholipids; D030262:Soybean Proteins