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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gut Microbiome, Serum Cholesterol

Intervention / Treatment
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* Other: Milk Polar Lipids
* Other: Milk Fat


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MPL-rich dairy beverage<br>Daily consumption of 100 g of dairy powder containing 5.3 g MPL for 4 weeks | Other: Milk Polar Lipids<br>* Effects of the addition of 5 g of milk polar lipids to 20 g milk fat.<br>Other: Milk Fat<br>* Effects of the addition of 20 g milk fat.<br>|
| Placebo Comparator: Control dairy beverage<br>Daily consumption of 100 g of dairy powder containing 0.3 g MPL for 4 weeks | Other: Milk Fat<br>* Effects of the addition of 20 g milk fat.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fecal Microbiota Shannon Index at 4 weeks | Measurement of fecal microbiota Shannon Index at the end of each 4-week intervention arms. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Milk, Polar Lipids, Phospholipids, Cholesterol, Microbiota, Microbiome