NCT00175097

Soybean Based Diets and CVD Risk Factors

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Tufts University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
OTHER	Diet: 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 soybeans and products made thereof.
OTHER	Diet: 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 flour and products made thereof.
OTHER	Diet: 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 soybean milk.
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 animal protein.

Timeline

• Start date: 2001-06-01
• Primary completion: 2005-05-01
• Completion: 2005-05-01
• First posted: 2005-09-15
• Last updated: 2014-12-02

Locations

2 sites across 1 country: United States