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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
243
Standardized muffin containing two levels of soy
Canadian Centre for Agri-food Research in Health and Medicine
Winnipeg, Manitoba, Canada
Human Nutraceutical Research Unit. University of Guelph
Guelph, Ontario, Canada
Glycemic Index Laboratories, Inc
Toronto, Ontario, Canada
Low Density Lipoprotein Cholesterol (LDL-Cholesterol)
Time frame: 6 weeks
high sensitivity c-reactive protein (hsCRP)
Time frame: 6 weeks
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