- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01547585
A Human Trial to Assess the Low Density Lipoprotein Cholesterol (LDL-C) Lowering Effect of Soy (SOY-LDL)
March 10, 2015 updated by: Dan Ramdath, Guelph Food Research Centre
A Randomized Controlled Trial to Determine the Low Density Lipoprotein Cholesterol (LDL-C) Lowering Effect of Whole Soy: a Dose Response Study
This study is being conducted to test the hypothesis that daily consumption of a baked food product containing whole soy for 6 weeks will significantly reduce plasma Low Density Lipoprotein Cholesterol (LDL-C) in individuals with hypercholesterolemia.
As such the overall goals of this study are to determine whether daily consumption of muffins made from whole soy flour for 6 weeks can lower plasma LDL-Cholesterol, and if so, establish whether the effect is dose-dependent.
To do this, study collaborators will: (1) conduct a detailed chemical and physical characterization of certified defatted whole soy flour that will be incorporated into a muffin; (2) formulate and produce a palatable whole soy flour muffin along with a control muffin containing wheat flour; (3) conduct a parallel controlled trial in which soy muffins will be fed randomly to persons with elevated LDL-cholesterol in a human clinical trial.
All participants will be randomized into one of three groups and asked to eat two muffins daily for 6 weeks in the following combination: high dose soy; control group or low dose soy.
Before, after, and mid-way during the feeding period, blood samples will be obtained for measurements of lipids, glucose, insulin, inflammation, and soy phytochemicals.
The effect of soy consumption on waist circumference, body mass index (BMI) and blood pressure will also be examined.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
243
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Manitoba
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Winnipeg, Manitoba, Canada, R2H 2A6
- Canadian Centre for Agri-food Research in Health and Medicine
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Ontario
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Guelph, Ontario, Canada, N1G 2W1
- Human Nutraceutical Research Unit. University of Guelph
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Toronto, Ontario, Canada, M5C 2N8
- Glycemic Index Laboratories, Inc
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and females (not pregnant or lactating) aged 30-70 year
- 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:
- Fasting plasma triglycerides ≥4.0 mmol/L
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Control
- Isocaloric control muffins
|
Standardized muffin containing two levels of soy
Other Names:
|
EXPERIMENTAL: Low Dose Soy
- Isocaloric muffins containing low dose of soy
|
Standardized muffin containing two levels of soy
Other Names:
|
EXPERIMENTAL: High Dose Soy
- Isocaloric muffins containing high dose soy
|
Standardized muffin containing two levels of soy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Low Density Lipoprotein Cholesterol (LDL-Cholesterol)
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
high sensitivity c-reactive protein (hsCRP)
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alison Duncan, PhD, RD, University of Guelph
- Principal Investigator: Heather Blewett, PhD, Canadian Centre for Agri-food Research in Health and Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (ACTUAL)
September 1, 2013
Study Completion (ACTUAL)
October 1, 2013
Study Registration Dates
First Submitted
March 5, 2012
First Submitted That Met QC Criteria
March 7, 2012
First Posted (ESTIMATE)
March 8, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
March 17, 2015
Last Update Submitted That Met QC Criteria
March 10, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOY-CVD-2012
- RBPI#1746 (OTHER_GRANT: Adriculture and Agri-Food Canada)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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