Hypercholesterolemia
Conditions
Keywords
soy protein, lipids, lipoproteins, apolipoproteins, cholesterol, endothelial function
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.
Interventions
OTHERDiet: 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.
OTHERDiet: 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.
OTHERDiet: 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.
OTHERDiet: 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.
Sponsors
Tufts University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C-reactive protein; end of each dietary phase | 24 weeks |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed