A Human Trial to Assess the Low Density Lipoprotein Cholesterol (LDL-C) Lowering Effect of Soy

Cardiovascular Disease Clinical Trial

— SOY-LDL  

Official title:

A Randomized Controlled Trial to Determine the Low Density Lipoprotein Cholesterol (LDL-C) Lowering Effect of Whole Soy: a Dose Response Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01547585
• Other study ID #: SOY-CVD-2012
• Secondary ID: RBPI#1746
• Status: Completed
• Phase: N/A
• First received: March 5, 2012
• Last updated: March 10, 2015
• Start date: May 2012
• Est. completion date: October 2013

Study information

• Verified date: March 2015
• Source: Guelph Food Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• CRP
• Hypercholesterolemia

Intervention

Other:
• Standardized soy containing muffin
Standardized muffin containing two levels of soy

Locations

Country	Name	City	State
Canada	Human Nutraceutical Research Unit. University of Guelph	Guelph	Ontario
Canada	Glycemic Index Laboratories, Inc	Toronto	Ontario
Canada	Canadian Centre for Agri-food Research in Health and Medicine	Winnipeg	Manitoba

Sponsors (4)

Lead Sponsor	Collaborator
Guelph Food Research Centre	Canadian Centre for Agri-Food Research in Health and Medicine, Glycemic Index Laboratories, Inc, University of Guelph

Country where clinical trial is conducted

Canada, 

References & Publications (12)

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. Review. — View Citation

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. — View Citation

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. Epub 2005 Dec 29. Review. — View Citation

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. — View Citation

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. Epub 2007 Nov 19. — View Citation

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. — View Citation

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. Review. — View Citation

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. Epub 2006 Jan 17. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low Density Lipoprotein Cholesterol (LDL-Cholesterol)		6 weeks
Secondary	high sensitivity c-reactive protein (hsCRP)		6 weeks