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

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.

Conditions

• Hypercholesterolemia
• Cardiovascular Disease
• CRP

Interventions

OTHER

Standardized soy containing muffin

Standardized muffin containing two levels of soy

Sponsors & Collaborators

• University of Guelph

  collaborator OTHER

• Glycemic Index Laboratories, Inc

  collaborator INDUSTRY

• Canadian Centre for Agri-Food Research in Health and Medicine

  collaborator OTHER

• Guelph Food Research Centre

  lead OTHER_GOV

Principal Investigators

• Alison Duncan, PhD, RD · University of Guelph

• Thomas Wolever, MD, PhD · Glycemic Index Laboratories, Inc

• Heather Blewett, PhD · Canadian Centre for Agri-Food Research in Health and Medicine

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-05-31

Primary Completion

2013-09-30

Completion

2013-10-31

Countries

• Canada

Study Locations