Impact of Different Forms of Soybean Based Foods on Cardiovascular Disease Risk Factors in Hypercholesterolemic Subjects.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tufts University
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Fasting and non-fasting plasma lipids, apolipoproteins; end of each dietary phase
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
soybeans and products made thereof
Diet: soybeans and products made thereof (soynuts, soynut butter, soy flakes & grits)
Intervention: Diet: soybeans and products made thereof (Other)
soybean flour and products made thereof
Diet: soybean flour and products made thereof (textured soybean)
Intervention: Diet: soybean flour and products made thereof (Other)
soybean milk
Diet: soybean milk (tofu, soybean yogurt, cheese, etc.)
Intervention: Diet: soybean milk (Other)
animal protein based diet
Diet: animal protein based diet
Intervention: Diet: Animal protein based diet (Other)
Outcomes
Primary Outcomes
Fasting and non-fasting plasma lipids, apolipoproteins; end of each dietary phase
Time Frame: 24 weeks
Vascular endothelial function; end of each dietary phase
Time Frame: 24 weeks
Susceptibility of LDL to oxidation; end of each dietary phase
Time Frame: 24 weeks
C-reactive protein; end of each dietary phase
Time Frame: 24 weeks
Secondary Outcomes
- 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)