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Completed

NCT Number: NCT00175097

Soybean Based Diets and CVD Risk Factors

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.

Completed

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Cardiology, Tufts-New England Medical Center Hospitals, Tufts University School of Medicine, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diet: soybeans and products made thereof

Other

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.

Diet: soybean flour and products made thereof

Other

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.

Diet: soybean milk

Other

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.

Diet: Animal protein based diet

Other

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.

Primary outcomes

  1. Fasting and non-fasting plasma lipids, apolipoproteins; end of each dietary phase

    Time frame: 24 weeks

  2. Vascular endothelial function; end of each dietary phase

    Time frame: 24 weeks

  3. Susceptibility of LDL to oxidation; end of each dietary phase

    Time frame: 24 weeks

  4. C-reactive protein; end of each dietary phase

    Time frame: 24 weeks

Secondary outcomes

  1. Endogenous cholesterol synthesis; end of each dietary phase

    Time frame: 24 weeks

  2. Endogenous triglyceride synthesis; end of each dietary phase

    Time frame: 24 weeks

  3. Plasma and Urinary Isoflavone levels; end of each dietary phase

    Time frame: 24 weeks

  4. Genotyping of candidate genes involved in the variability observed in response to dietary modification

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2005
Study completion
2005
First posted
Sep 15, 2005
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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