An interventional study of Milk Polar Lipids and Milk Fat in Serum Cholesterol and Gut Microbiome, sponsored by University of Connecticut. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-13.
Sponsored by University of Connecticut · Not applicable, Interventional, and Basic science
The purpose of this study is to examine whether the daily consumption of 5 g of milk polar lipids influences serum lipids and gut microbiota composition in healthy adults.
Healthy adults will be recruited to participate in a randomized, single-blind, controlled, 13-week crossover trial. Participants will follow a 2-week run-in control period consuming their habitual diets. Participants will then be randomized to consume 20 g of milk fat daily in the form of either a reconstituted milk polar lipid (MPL)-rich dairy beverage (MPL; providing 5.3 g MPL daily) or a control dairy beverage (CTL; providing 0.3 g MPL daily), each for 4- weeks, separated by a 3-week washout period. Participants will be instructed to consume intervention treatment/control beverages at breakfast (50 g) and dinner (50 g) and reconstitute the powders in water immediately prior to consumption. With the exception of the intervention beverages, participants will be asked to maintain their normal diet and exercise habits throughout the study. Venous blood will be collected after a 12-hour overnight fast into EDTA-coated (glucose analysis) and serum (lipid analyses) collection tubes. Passive drool and stool samples will be collected at the end of the run-in period (baseline) and intervention periods (treatment and control). Participants will be asked to complete a 5-day dietary record, food preference/liking/sedentary behavior surveys, and 7-day physical activity diary at the beginning and end of intervention periods.
University of Connecticut is the lead sponsor of 133 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Daily consumption of 100 g of dairy powder containing 5.3 g MPL for 4 weeks
Other: Milk Polar Lipids · Other: Milk Fat
Daily consumption of 100 g of dairy powder containing 0.3 g MPL for 4 weeks
Other: Milk Fat
Effects of the addition of 5 g of milk polar lipids to 20 g milk fat.
Effects of the addition of 20 g milk fat.
Change from Baseline Serum Total Cholesterol at 4 weeks
Measurement of serum cholesterol (mg/dL) at the beginning and end of each 4-week intervention arms.
Time frame: 4 weeks
Change in Fecal Microbiota Shannon Index at 4 weeks
Measurement of fecal microbiota Shannon Index at the end of each 4-week intervention arms.
Time frame: 4 weeks
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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University of Connecticut