Hostname: page-component-8448b6f56d-m8qmq Total loading time: 0 Render date: 2024-04-24T00:28:27.826Z Has data issue: false hasContentIssue false
  • English
  • Français

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

Published online by Cambridge University Press:  09 March 2007

Pekka Puska ,
Vesa Korpelainen ,
Lars H. Høie ,
Eva Skovlund  and
Knut T. Smerud
Pekka Puska*
Affiliation:
National Public Health Institute, Mannerheimintie 166, FIN-00300, Helsinki, Finland
Vesa Korpelainen
Affiliation:
North Karelia Project, Joensuu, Finland
Lars H. Høie
Affiliation:
Nutri Pharma A/S, Copenhagen, Denmark
Eva Skovlund
Affiliation:
Section of Medical Statistics, University of Oslo, Oslo, Norway
Knut T. Smerud
Affiliation:
Smerud Medical Research International AS, Oslo, Norway
*
*Corresponding author: Professor Pekka Puska, fax +358 9 474 48408, email pekka.puska@ktl.fi
Rights & Permissions [Opens in a new window]

Abstract

Core share and HTML view are not available for this content. However, as you have access to this content, a full PDF is available via the ‘Save PDF’ action button.

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 5·1mmol/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 0·40mmol/l; P<0·001), LDL-cholesterol (0·39mmol/l; P<0·001), non-HDL-cholesterol (0·40mmol/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.

Keywords

Soya proteinFibreIsoflavonesPhospholipidsHypercholesterolaemia
Type
Research Article
Information
British Journal of Nutrition , Volume 91 , Issue 3 , March 2004 , pp. 393 - 401
Copyright
Copyright © The Nutrition Society 2004

References

Adlercreutz, H (1998) Epidemiology of phytoestrogens. Ballières Clin Endocrinol Metab 12, 605–623.Google Scholar
Anderson, JW (2003) Diet first, then medication for hypercholesterolemia. J Am Med Assoc 290, 531–533.Google Scholar
Anderson, JW, Johnstone, BM & Cook-Newell, ME (1995) Meta-analysis of the effects of soy protein intake on serum lipids. N Engl J Med 333, 276–282.CrossRefGoogle ScholarPubMed
Anderson, JW, Smith, BM & Washnock, CS (1999) Cardiovascular and renal benefits of dry bean and soybean intake. Am J Clin Nutr 70, Suppl., 464S–474S.Google Scholar
Anonymous (1998) Joint British recommendations on prevention of coronary heart disease in clinical practice. British Cardiac Society, British Hyperlipidaemia Association, British Hypertension Society, endorsed by the British Diabetic Association. Heart 80, Suppl. 2, 1S–29S.Google Scholar
Anonymous (2002) Third Report of the National Cholesterol Education Program (NCEP). Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III final report). Circulation 106, 3143–3421.Google Scholar
Avorn, J, Monette, J, Lacour, A, Bohn, RL, Mogun, H & LeLorier, J (1998) Persistence of use of lipid-lowering medications: a cross-national study. J Am Med Assoc 279, 1458–1462.CrossRefGoogle ScholarPubMed
Baum, JA, Teng, H, Erdman, JW Jr, et al. (1998) Long-term intake of soy protein improves blood lipid profiles and increases mononuclear cell low-density-lipoprotein receptor messenger RNA in hypercholesterolemic, postmenopausal women. Am J Clin Nutr 68, 545–551.CrossRefGoogle ScholarPubMed
Boushey, CJ, Beresford, SA, Omenn, GS & Motulsky, AG (1995) A quantitative assessment of plasma homocysteine as a risk factor for vascular disease. Probable benefits of increasing folic acid intakes. JAMA 274, 1049–1057.CrossRefGoogle ScholarPubMed
Crouse, JR III, Morgan, T, Terry, JG, Ellis, J, Vitolins, M & Burke, GL (1999) A randomized trial comparing the effect of casein with that of soy protein containing varying amounts of isoflavones of plasma concentrations of lipids and lipoproteins. Arch Intern Med 159, 2070–2076.Google Scholar
European Agency for the Evaluation of Medicinal Products (1996) ICH Topic E6: Note for Guidance on Good Clinical Practice, CPMP/ICH/135/95. London: European Agency for the Evaluation of Medicinal Products.Google Scholar
European Agency for the Evaluation of Medicinal Products (1997) ICH Topic E8: Note for Guidance on General Considerations for Clinical Trials, CPMP/ICH/291/95. London: European Agency for the Evaluation of Medicinal Products.Google Scholar
European Agency for the Evaluation of Medicinal Products (1998) ICH Topic E9: Note for Guidance on Statistical Principles for Clinical Trials, CPMP/ICH/363/96. London: European Agency for the Evaluation of Medicinal Products.Google Scholar
European Agency for the Evaluation of Medicinal Products (2000) ICH Topic E10: Note for Guidance on Choice of Control Groups in Clinical Trials, CPMP/ICH/364/96. London: European Agency for the Evaluation of Medicinal Products.Google Scholar
European Agency for the Evaluation of Medicinal Products (2001) Concept Paper on the Development of a Committee for Proprietary Medicinal Products (CPMP) Note for Guidance on the Evaluation of Medicinal Products for the Treatment of Dyslipoproteinaemia, CPMP/EWP/512/01. London: European Agency for the Evaluation of Medicinal Products.Google Scholar
Friedewald, WT, Levy, RI & Fredrickson, DS (1972) Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem 18, 499–502.Google Scholar
Gerhard, GT & Duell, PB (1999) Homocysteine and atherosclerosis. Curr Opin Lipidol 10, 417–428.Google Scholar
Grundy, SM (2000) Early detection of high cholesterol levels in young adults. J Am Med Assoc 284, 865–867.Google Scholar
Heart Protection Study Collaborative Group (2002) MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20 536 high-risk individuals: a randomised placebo-controlled trial. Lancet 360, 7–22.Google Scholar
Hsia, SL, He, JL, Nie, Y, Fong, K & Milikowski, C (1996) The hypocholesterolemic and antiatherogenic effects of topically applied phosphatidylcholine in rabbits with heritable hypercholesterolemia. Artery 22, 1–23.Google Scholar
Ishida, T, Koba, K, Sugano, M, Imaizumi, K, Watanabe, S & Minoshima, RM (1988) Cholesterol levels and eicosanoid production in rats fed phosphatidylinositol or soybean lecithin. J Nutr Sci Vitaminol 34, 237–244.Google Scholar
Law, MR, Wald, NJ & Thompson, SG (1994) By how much and how quickly does reduction in serum cholesterol concentration lower risk of ischaemic heart disease? BMJ 308, 367–372.Google Scholar
LeBlanc, MJ, Gavino, V, Perea, A, Yousef, IM, Lévy, E & Tuchweber, B (1998) The role of dietary choline in the beneficial effects of lecithin on the secretion of biliary lipids in rats. Biochim Biophys Acta 1393, 223–234.CrossRefGoogle ScholarPubMed
Lovati, MR, Manzoni, C, Gianazza, E, Arnoldi, A, Kurowska, E, Carroll, KK & Sirtori, CR (2000) Soy protein peptides regulate cholesterol homeostasis in Hep G2 cells. J Nutr 130, 2543–2549.Google Scholar
Merz-Demlow, BE, Duncan, AM, Wangen, KE, Xu, X, Carr, TP, Phipps, WR & Kurzer, MS (2000) Soy isoflavones improve plasma lipids in normocholesterolemic, premenopausal women. Am J Clin Nutr 71, 1462–1469.Google Scholar
Monkman, D (2000) Treating dyslipidaemia in primary care (editorial comment). BMJ 321, 1299–1300.Google Scholar
Navder, KP, Baraona, E & Lieber, CS (2000) Dilinoleoylphosphatidylcholine protects human low density lipoproteins against oxidation. Atherosclerosis 152, 89–95.Google Scholar
Nishina, PM & Freedland, RA (1990) The effects of dietary fiber feeding on cholesterol metabolism in rats. J Nutr 120, 800–805.Google Scholar
Pietinen, P, Vartiainen, E, Seppänen, R, Aro, A & Puska, P (1996) Changes in diet in Finland from 1972 to 1992: impact on coronary heart disease risk. Prev Med 25, 243–250.CrossRefGoogle ScholarPubMed
Polichetti, E, Diaconescu, N, de la Porte, PL, Malli, L, Portugal, H, Pauli, AM, Lafont, H, Tuchweber, B, Yousef, I & Chanussot, F (1996) Cholesterol-lowering effect of soyabean lecithin in normolipidaemic rats by stimulation of biliary lipid secretion. Br J Nutr 75, 471–481.Google Scholar
Polichetti, E, Janisson, A, de la Porte, PL, Portugal, H, Léonardi, J, Luna, A, La Droitte, P & Chanussot, F (2000) Dietary polyenylphosphatidylcholine decreases cholesterolemia in hypercholesterolemic rabbits: role of the hepato-biliary axis. Life Sci 67, 2563–2576.Google Scholar
Potter, SM (1998) Soy proteins and cardiovascular disease: the impact of bioactive components in soy. Nutr Rev 56, 231–235.Google Scholar
Primatesta, P & Poulter, NR (2000) Lipid concentrations and the use of lipid lowering drugs: evidence from a national cross sectional survey. BMJ 321, 1322–1325.Google Scholar
Puska, P, Korpelainen, V, Høie, LH, Skovlund, E, Lahti, T & Smerud, K (2002) Soy in hypercholesterolemia: a double-blind, placebo-controlled trial. Eur J Clin Nutr 56, 352–357.Google Scholar
Rosseneu, M, Declercq, B, Vandamme, D, Vercaemst, R, Soetewey, F, Peeters, H & Blaton, V (1979) Influence of oral polyunsaturated and saturated phospholipid treatment on the lipid composition and fatty acid profile of chimpanzee lipoproteins. Atherosclerosis 32, 141–153.CrossRefGoogle ScholarPubMed
Rössner, S & Flaten, H (1997) VLCD versus LCD in long-term treatment of obesity. Int J Obes Relat Metab Disord 21, 22–26.Google Scholar
Ryttig, KR, Flaten, H & Rössner, S (1997) Long-term effects of a very low calorie diet (Nutrilett) in obesity treatment. A prospective, randomized, comparison between VLCD and a hypocaloric diet+behaviour modification and their combination. Int J Obes Relat Metab Disord 21, 574–579.Google Scholar
Sandström, B (1995) Quality criteria in human experimental nutrition research. Eur J Clin Nutr 49, 315–322.Google Scholar
Shepherd, J, Cobbe, SM, Ford, I, Isles, CG, Lorimer, AR, MacFarlane, PW, McKillop, JH & Packard, CJ (1995) Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group. N Engl J Med 333, 1301–1307.CrossRefGoogle ScholarPubMed
Stamler, J, Daviglus, ML, Garside, DB, Dyer, AR, Greenland, P & Neaton, JD (2000) Relationship of baseline serum cholesterol levels in 3 large cohorts of younger men to long-term coronary, cardiovascular, and all-cause mortality and to longevity. J Am Med Assoc 284, 311–318.Google Scholar
Teixeira, SR, Potter, SM, Weigel, R, Hannum, S, Erdman, JW Jr & Hasler, CM (2000) Effects of feeding 4 levels of soy protein for 3 and 6 weeks on blood lipids and apolipoproteins in moderately hypercholesterolemic men. Am J Clin Nutr 71, 1077–1084.Google Scholar
The Long Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group (1998) Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med 339, 1349–1357.Google Scholar
The Scandinavian Simvastatin Survival Study Group (1994) Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 344, 1383–1389.Google Scholar
The Swedish Medical Product Agency and the Norwegian Medicines Control Authority (1996) Workshop: Treatment of Hyperlipidaemia. 1996–1992. Stockholm: The Swedish Medical Product Agency and the Norwegian Medicines Control Authority.Google Scholar
Tonstad, S, Smerud, K & Høie, L (2002) A comparison of the effects of 2 doses of soy protein or casein on serum lipids, serum lipoproteins, and plasma total homocysteine in hypercholesterolemic subjects. Am J Clin Nutr 76, 78–84.Google Scholar
US Food and Drug Administration (1999) Food labeling: health claims; soy protein and coronary heart disease. Federal register: October 26, 1999 (Volume 64, Number 206) Rules and regulations: 21 CFR part 101 (Docket no. 98P-0683): 57699–731. http://www.wais.access.gpo.gov.htmGoogle Scholar
Vartiainen, E, Puska, P, Pekkanen, J, Tuomilehto, & Jousilahti, P (1994) Changes in risk factors explain changes in mortality from ischaemic heart disease in Finland.. BMJ 309, 23–27.CrossRefGoogle ScholarPubMed
Wald, DS, Law, M & Morris, JK (2002) Homocysteine and cardiovascular disease: evidence on causality from a meta-analysis. BMJ 325, 1202–1206.Google Scholar
Wang, GJ, Lapcik, O, Hampl, R, Uehara, M, Al-Maharik, N, Stumpf, K, Mikola, H, Wahala, K & Adlercreutz, H (2000) Time-resolved fluoroimmunoassay of plasma daidzein and genistein. Steroids 65, 339–348.Google Scholar
Wong, WW, O'Brian Smith, E, Stuff, JE, Hachey, DL, Heird, WC & Pownell, HJ (1998) Cholesterol-lowering effect of soy protein in normocholesterolemic and hypercholesterolemic men. Am J Clin Nutr 68, Suppl., 1385S–1389S.Google Scholar