title: Double-blind study of the addition of high-protein soya milk v. cows' milk to the diet of patients with severe hypercholesterolaemia and resistance to or intolerance of statins.
abstract: Total substitution of soyabean protein for animal protein in the diet has been repeatedly shown to lower plasma cholesterol levels in hypercholesterolaemic individuals. A new, highly palatable, high-protein soya drink may allow replacement of a significant percentage of animal protein in the diet. The soya drink was given, within a crossover design v. a cows' milk preparation of similar composition and taste, to twenty-one severely hypercholesterolaemic patients (mean baseline plasma cholesterol 8.74 mmol/l) with a history of resistance to or intolerance of statin treatment. Each dietary supplement was given for 4 weeks, with a 4-week interval between treatments, Plasma lipid levels were monitored every 2 weeks during each dietary sequence. The concomitant dietary treatment, which had been followed for a long time by all patients, was carefully monitored throughout the study. The soya supplementation reduced plasma total cholesterol level by 6.5%, when given first, and by 7.4% when given after cows' milk. When given first, cows' milk resulted in a small, non-significant reduction of plasma cholesterol level (-3.9%), and when given after soya, it changed total plasma cholesterol to a minimal extent (-1.6%). Changes in total and LDL-cholesterol levels after 2 and 4 weeks of soya v. cows' milk treatment were, thus, respectively -6.1, -7.0 and -6.2, -7.8% (both P < 0.05). These first data from a double-blind study confirm a significant cholesterol-lowering effect of soyabean protein, even when only partly replacing animal protein in the diet, in individuals with extreme plasma cholesterol elevations.
authors.affiliation: Center E. Grossi Paoletti, Institute of Pharmacological Sciences, University of Milan, Italy. cesare.sirtori@unimi.it
authors.forename: C R
authors.initials: CR
authors.lastname: Sirtori
authors.forename: F
authors.initials: F
authors.lastname: Pazzucconi
authors.forename: L
authors.initials: L
authors.lastname: Colombo
authors.forename: P
authors.initials: P
authors.lastname: Battistin
authors.forename: A
authors.initials: A
authors.lastname: Bondioli
authors.forename: K
authors.initials: K
authors.lastname: Descheemaeker
mesh_terms: D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000818:Animals; D002784:Cholesterol / Q000097:blood*; D008078:Cholesterol, LDL / Q000097:blood; D000075202:Contraindications; D018592:Cross-Over Studies; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D006937:Hypercholesterolemia / Q000097:blood / Q000178:diet therapy*; D008297:Male; D008875:Middle Aged; D008892:Milk; D030262:Soybean Proteins / Q000627:therapeutic use*
chemical_list: D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D030262:Soybean Proteins; D002784:Cholesterol