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

Sponsor

Guelph Food Research Centre (Other)

Overall Status

Completed

CT.gov ID

NCT01547585

Collaborator

University of Guelph (Other), Glycemic Index Laboratories, Inc (Industry), Canadian Centre for Agri-Food Research in Health and Medicine (Other)

243

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia Cardiovascular Disease CRP	Other: Standardized soy containing muffin	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

243 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control - Isocaloric control muffins	Other: Standardized soy containing muffin Standardized muffin containing two levels of soy Other Names: Soy containing muffins
Experimental: Low Dose Soy - Isocaloric muffins containing low dose of soy	Other: Standardized soy containing muffin Standardized muffin containing two levels of soy Other Names: Soy containing muffins
Experimental: High Dose Soy - Isocaloric muffins containing high dose soy	Other: Standardized soy containing muffin Standardized muffin containing two levels of soy Other Names: Soy containing muffins

Arm

Intervention/Treatment

Placebo Comparator: Control

- Isocaloric control muffins

Other: Standardized soy containing muffin

Standardized muffin containing two levels of soy

Other Names:

Soy containing muffins

Experimental: Low Dose Soy

- Isocaloric muffins containing low dose of soy

Other: Standardized soy containing muffin

Standardized muffin containing two levels of soy

Other Names:

Soy containing muffins

Experimental: High Dose Soy

- Isocaloric muffins containing high dose soy

Other: Standardized soy containing muffin

Standardized muffin containing two levels of soy

Other Names:

Soy containing muffins

Outcome Measures

Primary Outcome Measures

Low Density Lipoprotein Cholesterol (LDL-Cholesterol) [6 weeks]

Secondary Outcome Measures

high sensitivity c-reactive protein (hsCRP) [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Canadian Centre for Agri-food Research in Health and Medicine	Winnipeg	Manitoba	Canada	R2H 2A6
2	Human Nutraceutical Research Unit. University of Guelph	Guelph	Ontario	Canada	N1G 2W1
3	Glycemic Index Laboratories, Inc	Toronto	Ontario	Canada	M5C 2N8

Sponsors and Collaborators

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

Investigators

Principal Investigator: Alison Duncan, PhD, RD, University of Guelph
Principal Investigator: Thomas Wolever, MD, PhD, Glycemic Index Laboratories, Inc
Principal Investigator: Heather Blewett, PhD, Canadian Centre for Agri-Food Research in Health and Medicine