Soybean Based Diets and CVD Risk Factors

Study Overview
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Brief Summary
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To evaluate the impact of soybean processing as well as the effect of soy relative to animal protein, independent of alterations in the fatty acid profile of the diet on CVD risk factors in hypercholesterolemic subjects.

Detailed Description
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Recent data suggests that the magnitude of the effect of soy protein on lipid and lipoprotein levels is variable and less dramatic than originally reported. This discordance might be attributable to the forms of soy protein used, as well as subtle unrecognized shifts in the fatty acid, cholesterol and fiber content of the diets.The aim of the present investigation is to assess the effects of different forms of soybeans (whole bean and products made thereof), products derived from soy flour (textured soy protein) and products made from a soybean extract (i.e. tofu, yogurt) relative to animal protein, independent of alterations in the fatty acid profile of the diet on CVD risk factors in hypercholesterolemic subjects. The intent is to isolate any potential impact of processing on the plasma lipid lowering efficacy of the soy product or soy protein relative to animal protein.

Official Title
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Impact of Different Forms of Soybean Based Foods on Cardiovascular Disease Risk Factors in Hypercholesterolemic Subjects.

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Other: Diet: soybeans and products made thereof
* Other: Diet: soybean flour and products made thereof
* Other: Diet: soybean milk
* Other: Diet: Animal protein based diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Plasma LDL-C >120mg/dL, Free from chronic illness, Not taking medications known to affect lipid metabolism (lipid lowering drugs, beta-blockers, fish-oil capsules, cis-retinoic acid, ascorbic acid, vitamin E, diuretics or hormones), Post-menopausal women. Exclusion Criteria: Soy allergy, Smokers, Consuming >2 alcoholic drinks per day, Pre-menopausal women.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: soybeans and products made thereof<br>Diet: soybeans and products made thereof (soynuts, soynut butter, soy flakes & grits) | Other: Diet: soybeans and products made thereof<br>* The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate soybeans and products made thereof.<br>|
| Other: soybean flour and products made thereof<br>Diet: soybean flour and products made thereof (textured soybean) | Other: Diet: soybean flour and products made thereof<br>* The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate soybean flour and products made thereof.<br>|
| Other: soybean milk<br>Diet: soybean milk (tofu, soybean yogurt, cheese, etc.) | Other: Diet: soybean milk<br>* The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate soybean milk.<br>|
| Other: animal protein based diet<br>Diet: animal protein based diet | Other: Diet: Animal protein based diet<br>* The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate animal protein.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting and non-fasting plasma lipids, apolipoproteins; end of each dietary phase |  | 24 weeks | 
| Vascular endothelial function; end of each dietary phase |  | 24 weeks | 
| Susceptibility of LDL to oxidation; end of each dietary phase |  | 24 weeks | 
| C-reactive protein; end of each dietary phase |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endogenous cholesterol synthesis; end of each dietary phase |  | 24 weeks | 
| Endogenous triglyceride synthesis; end of each dietary phase |  | 24 weeks | 
| Plasma and Urinary Isoflavone levels; end of each dietary phase |  | 24 weeks | 
| Genotyping of candidate genes involved in the variability observed in response to dietary modification |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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soy protein, lipids, lipoproteins, apolipoproteins, cholesterol, endothelial function