Soybean Based Diets and CVD Risk Factors
- Conditions
- Hypercholesterolemia
- Registration Number
- NCT00175097
- Lead Sponsor
- Tufts University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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.
Soy allergy, Smokers, Consuming >2 alcoholic drinks per day, Pre-menopausal women.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (2)
Division of Cardiology, Tufts-New England Medical Center Hospitals, Tufts University School of Medicine
🇺🇸Boston, Massachusetts, United States
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
🇺🇸Boston, Massachusetts, United States