A Human Trial to Assess the Low Density Lipoprotein Cholesterol (LDL-C) Lowering Effect of Soy
NCT ID: NCT01547585
Last Updated: 2015-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
243 participants
INTERVENTIONAL
2012-05-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Control
\- Isocaloric control muffins
Standardized soy containing muffin
Standardized muffin containing two levels of soy
Low Dose Soy
\- Isocaloric muffins containing low dose of soy
Standardized soy containing muffin
Standardized muffin containing two levels of soy
High Dose Soy
\- Isocaloric muffins containing high dose soy
Standardized soy containing muffin
Standardized muffin containing two levels of soy
Interventions
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Standardized soy containing muffin
Standardized muffin containing two levels of soy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) ≤40kg/m² and ≥18.5kg/m²
* Fasting plasma total cholesterol ≥5.0
* Fasting plasma LDL cholesterol ≥3.0 and \<5.0 mmol/L.
Exclusion Criteria
* Abnormal liver and kidney function
* Unstable body weight(\>3kg change in 3 months) or intention to lose or gain weight;
* Diabetes mellitus (fasting plasma glucose ≥7.0 mmol/L or use of insulin or any hypoglycemic or anti-hyperglycemic medication);
* Use of any prescription or non-prescription drug, prebiotics or probiotics, herbal or nutritional supplement known to affect blood lipids, except for stable doses (no change in 3 months) of thyroxine, oral contraceptive agents, hormone replacement therapy, and medications for controlling blood pressure);
* Major surgical or medical events within the past 3 months;
* Presence of a gastrointestinal disorder or medication that alters the digestion and absorption of nutrients; including antibiotic use within the past 6 weeks.
* Consumption of a diet containing ≥15% of energy from saturated fat;
* Any food allergy or aversion or unwillingness to eat wheat, soy or milk;
* Consumption of ≥5 servings per week of soy based food products;
* Consumption of an average of \>2 alcoholic beverages per day;
* Regular smokers (smoking ≥1 cigarette per day) of cigarettes or cigars
30 Years
70 Years
ALL
Yes
Sponsors
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University of Guelph
OTHER
Glycemic Index Laboratories, Inc
INDUSTRY
Canadian Centre for Agri-Food Research in Health and Medicine
OTHER
Guelph Food Research Centre
OTHER_GOV
Responsible Party
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Dan Ramdath
Principal Investigator
Principal Investigators
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Alison Duncan, PhD, RD
Role: PRINCIPAL_INVESTIGATOR
University of Guelph
Thomas Wolever, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Glycemic Index Laboratories, Inc
Heather Blewett, PhD
Role: PRINCIPAL_INVESTIGATOR
Canadian Centre for Agri-Food Research in Health and Medicine
Locations
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Canadian Centre for Agri-food Research in Health and Medicine
Winnipeg, Manitoba, Canada
Human Nutraceutical Research Unit. University of Guelph
Guelph, Ontario, Canada
Glycemic Index Laboratories, Inc
Toronto, Ontario, Canada
Countries
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References
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Reinwald S, Akabas SR, Weaver CM. Whole versus the piecemeal approach to evaluating soy. J Nutr. 2010 Dec;140(12):2335S-2343S. doi: 10.3945/jn.110.124925. Epub 2010 Oct 27.
Zhang X, Shu XO, Gao YT, Yang G, Li Q, Li H, Jin F, Zheng W. Soy food consumption is associated with lower risk of coronary heart disease in Chinese women. J Nutr. 2003 Sep;133(9):2874-8. doi: 10.1093/jn/133.9.2874.
Kokubo Y, Iso H, Ishihara J, Okada K, Inoue M, Tsugane S; JPHC Study Group. Association of dietary intake of soy, beans, and isoflavones with risk of cerebral and myocardial infarctions in Japanese populations: the Japan Public Health Center-based (JPHC) study cohort I. Circulation. 2007 Nov 27;116(22):2553-62. doi: 10.1161/CIRCULATIONAHA.106.683755. Epub 2007 Nov 19.
Nanri A, Mizoue T, Takahashi Y, Kirii K, Inoue M, Noda M, Tsugane S. Soy product and isoflavone intakes are associated with a lower risk of type 2 diabetes in overweight Japanese women. J Nutr. 2010 Mar;140(3):580-6. doi: 10.3945/jn.109.116020. Epub 2010 Jan 6.
Yang B, Chen Y, Xu T, Yu Y, Huang T, Hu X, Li D. Systematic review and meta-analysis of soy products consumption in patients with type 2 diabetes mellitus. Asia Pac J Clin Nutr. 2011;20(4):593-602.
Anderson JW, Bush HM. Soy protein effects on serum lipoproteins: a quality assessment and meta-analysis of randomized, controlled studies. J Am Coll Nutr. 2011 Apr;30(2):79-91. doi: 10.1080/07315724.2011.10719947.
Anderson JW, Johnstone BM, Cook-Newell ME. Meta-analysis of the effects of soy protein intake on serum lipids. N Engl J Med. 1995 Aug 3;333(5):276-82. doi: 10.1056/NEJM199508033330502.
Zhan S, Ho SC. Meta-analysis of the effects of soy protein containing isoflavones on the lipid profile. Am J Clin Nutr. 2005 Feb;81(2):397-408. doi: 10.1093/ajcn.81.2.397.
Dewell A, Hollenbeck PL, Hollenbeck CB. Clinical review: a critical evaluation of the role of soy protein and isoflavone supplementation in the control of plasma cholesterol concentrations. J Clin Endocrinol Metab. 2006 Mar;91(3):772-80. doi: 10.1210/jc.2004-2350. Epub 2005 Dec 29.
Sirtori CR, Eberini I, Arnoldi A. Hypocholesterolaemic effects of soya proteins: results of recent studies are predictable from the anderson meta-analysis data. Br J Nutr. 2007 May;97(5):816-22. doi: 10.1017/S0007114507670810.
Sacks FM, Lichtenstein A, Van Horn L, Harris W, Kris-Etherton P, Winston M; American Heart Association Nutrition Committee. Soy protein, isoflavones, and cardiovascular health: an American Heart Association Science Advisory for professionals from the Nutrition Committee. Circulation. 2006 Feb 21;113(7):1034-44. doi: 10.1161/CIRCULATIONAHA.106.171052. Epub 2006 Jan 17.
Klein MA, Nahin RL, Messina MJ, Rader JI, Thompson LU, Badger TM, Dwyer JT, Kim YS, Pontzer CH, Starke-Reed PE, Weaver CM. Guidance from an NIH workshop on designing, implementing, and reporting clinical studies of soy interventions. J Nutr. 2010 Jun;140(6):1192S-1204S. doi: 10.3945/jn.110.121830. Epub 2010 Apr 14.
Padhi EM, Blewett HJ, Duncan AM, Guzman RP, Hawke A, Seetharaman K, Tsao R, Wolever TM, Ramdath DD. Whole Soy Flour Incorporated into a Muffin and Consumed at 2 Doses of Soy Protein Does Not Lower LDL Cholesterol in a Randomized, Double-Blind Controlled Trial of Hypercholesterolemic Adults. J Nutr. 2015 Dec;145(12):2665-74. doi: 10.3945/jn.115.219873. Epub 2015 Oct 7.
Other Identifiers
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RBPI#1746
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SOY-CVD-2012
Identifier Type: -
Identifier Source: org_study_id
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