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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
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.
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.
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.
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
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
Endogenous cholesterol synthesis; end of each dietary phase
Time frame: 24 weeks
Endogenous triglyceride synthesis; end of each dietary phase
Time frame: 24 weeks
Plasma and Urinary Isoflavone levels; end of each dietary phase
Time frame: 24 weeks
Genotyping of candidate genes involved in the variability observed in response to dietary modification
Time frame: 24 weeks
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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.