An interventional study of Diet: soybeans and products made thereof and Diet: soybean flour and products made thereof in Hypercholesterolemia, sponsored by Tufts University. Completed at 2 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2014-12-02.
Sponsored by Tufts University · Not applicable, Interventional, and Treatment
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.
1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.
This study's enrollment of 30 is below the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Tufts University is the lead sponsor of 225 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Diet: soybeans and products made thereof (soynuts, soynut butter, soy flakes \& grits)
Other: Diet: soybeans and products made thereof
Diet: soybean flour and products made thereof (textured soybean)
Other: Diet: soybean flour and products made thereof
Diet: soybean milk (tofu, soybean yogurt, cheese, etc.)
Other: Diet: soybean milk
Diet: animal protein based diet
Other: Diet: Animal protein based diet
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.
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.
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
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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