NCT01547585

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: Guelph Food Research Centre · Other Government
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
OTHER	Standardized soy containing muffin	Standardized muffin containing two levels of soy

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-09-01
• Completion: 2013-10-01
• First posted: 2012-03-08
• Last updated: 2015-03-17

Locations

3 sites across 1 country: Canada