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

Study Overview
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Brief Summary
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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.

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

Conditions
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CRP, Hypercholesterolemia, Cardiovascular Disease

Intervention / Treatment
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* Other: Standardized soy containing muffin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>- Isocaloric control muffins | Other: Standardized soy containing muffin<br>* Standardized muffin containing two levels of soy<br>* Other names: Soy containing muffins;|
| Experimental: Low Dose Soy<br>- Isocaloric muffins containing low dose of soy | Other: Standardized soy containing muffin<br>* Standardized muffin containing two levels of soy<br>* Other names: Soy containing muffins;|
| Experimental: High Dose Soy<br>- Isocaloric muffins containing high dose soy | Other: Standardized soy containing muffin<br>* Standardized muffin containing two levels of soy<br>* Other names: Soy containing muffins;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low Density Lipoprotein Cholesterol (LDL-Cholesterol) |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| high sensitivity c-reactive protein (hsCRP) |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholesterol, Cardiovascular disease, Soy, Dose-response