Hypercholesterolemia Clinical Trial
Official title:
Effect of a Plant Sterol-Fortified Low-fat Milk Product on Plasma Lipid Levels of Humans in Relation to Different Infant Feeding Practices and Later Life Cholesterol Metabolism
The overall goal of this clinical study is to investigate how dietary cholesterol intake influences the plasma Total cholesterol (TC), LDL-Cholesterol levels and cholesterol metabolism between adults who had been breast-fed as infants as a function of the duration of breast feeding and quantity of early cholesterol intake. The study also aims to evaluate the effect of a plant sterol formulation in low fat milk shake in modulating the lipid profile favorably in the study population.
Hypothesis 1: To determine the responsiveness of plasma lipid profile including Total
cholesterol and LDL cholesterol concentrations to high and low cholesterol diets in adults
who been breast-fed as infants for different durations
Hypothesis 2: To determine if differences exist in rates of cholesterol absorption and
synthesis in adults, and whether such differences respond to variations in cholesterol
intake, between individuals who were breast for different durations.
Hypothesis 3: Consumption of a plant sterol formulation in low-fat milk product will
favorably alter lipid profiles compared with control in the study population.
This is a free-living, randomized, crossover trial. This trial is modeled after previously
successful functional food trial at the investigators clinic, consistent with current
recommendations to decrease Cardiovascular diseases (CVD) risk and improve circulating lipid
profiles. The proposed study will include three treatment phases of 4 weeks each, separated
by 4-week washout intervals:
Phase 1: Study diets with placebo (240 ml of 2% milk shake; 50 mg cholesterol).
Phase 2: Study diets with enriched cholesterol (240ml of 2% milk shake; 600 mg cholesterol).
Phase 3: A study diet with plant sterols (240 ml of 2% milk shake;2.0 g/d of plant
sterols/240 ml serving; 50 mg cholesterol).
During each treatment period participants will consume their supper time meal along with
assigned test product. Consumption of the suppertime meals and the test products will be
monitored by a clinical coordinator to ensure compliance. Participants will be asked to fill
out a 3-day food diary at the beginning and end of each experimental period.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
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