Evaluation of Dietary Milk Polar Lipids on Serum Cholesterol and Gut Microbiota in Healthy Adults
January 11, 2022 updated by: Christopher Blesso, University of Connecticut
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
Storrs, Connecticut, United States, 06269
- University of Connecticut
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: MPL-rich dairy beverage
Daily consumption of 100 g of dairy powder containing 5.3 g MPL for 4 weeks
|
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.
|
|
PLACEBO_COMPARATOR: Control dairy beverage
Daily consumption of 100 g of dairy powder containing 0.3 g MPL for 4 weeks
|
Effects of the addition of 20 g milk fat.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2020
Primary Completion (ACTUAL)
October 31, 2021
Study Completion (ACTUAL)
October 31, 2021
Study Registration Dates
First Submitted
December 18, 2019
First Submitted That Met QC Criteria
December 19, 2019
First Posted (ACTUAL)
December 23, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 13, 2022
Last Update Submitted That Met QC Criteria
January 11, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- H19-122
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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