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OpenTrials
Completed

NCT Number: NCT04208815

Evaluation of Dietary Milk Polar Lipids on Serum Cholesterol and Gut Microbiota in Healthy Adults

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut

Storrs, Connecticut, 06269, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 18 to 50 years
  • Body Mass Index < 30 kg/m^2
  • Willing to consume experimental intervention products on a daily basis

Exclusion criteria

  • Outside of age range (<18 or >50 years old)
  • Body Mass Index > 30 kg/m^2
  • Triglycerides are higher than 500 mg/dL, glucose levels higher than 126 mg/dL, or total cholesterol higher than 240 mg/dL
  • Self-reported history of renal or liver disease, diabetes, thyroid disease, gallbladder disease, eating disorders, heart disease, stroke, cancer and gut-associated pathologies
  • Weight loss greater than 10% of body weight over preceding 4 weeks
  • Taking probiotic supplements or oral antibiotics up to 1 month prior to the study and during the study
  • Allergy to dairy or lactose intolerance
  • Taking lipid-lowering medications

Treatment and study plan

Milk Polar Lipids

Other

Effects of the addition of 5 g of milk polar lipids to 20 g milk fat.

Milk Fat

Other

Effects of the addition of 20 g milk fat.

Primary outcomes

  1. Change from Baseline Serum Total Cholesterol at 4 weeks

    Time frame: 4 weeks

    Measurement of serum cholesterol (mg/dL) at the beginning and end of each 4-week intervention arms.

Secondary outcomes

  1. Change in Fecal Microbiota Shannon Index at 4 weeks

    Time frame: 4 weeks

    Measurement of fecal microbiota Shannon Index at the end of each 4-week intervention arms.

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 23, 2019
Registry last updated
Jan 13, 2022

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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