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

Sponsor

University of Connecticut (Other)

Overall Status

Completed

CT.gov ID

NCT04208815

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Serum Cholesterol Gut Microbiome	Other: Milk Polar Lipids Other: Milk Fat	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Mar 1, 2020

Actual Primary Completion Date :

Oct 31, 2021

Actual Study Completion Date :

Oct 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MPL-rich dairy beverage Daily consumption of 100 g of dairy powder containing 5.3 g MPL for 4 weeks	Other: Milk Polar Lipids Effects of the addition of 5 g of milk polar lipids to 20 g milk fat. Other: 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	Other: Milk Fat Effects of the addition of 20 g milk fat.

Arm

Intervention/Treatment

Experimental: MPL-rich dairy beverage

Daily consumption of 100 g of dairy powder containing 5.3 g MPL for 4 weeks

Other: Milk Polar Lipids

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

Other: 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

Other: Milk Fat

Effects of the addition of 20 g milk fat.

Outcome Measures

Primary Outcome Measures

Change from Baseline Serum Total Cholesterol at 4 weeks [4 weeks]
Measurement of serum cholesterol (mg/dL) at the beginning and end of each 4-week intervention arms.

Secondary Outcome Measures

Change in Fecal Microbiota Shannon Index at 4 weeks [4 weeks]
Measurement of fecal microbiota Shannon Index at the end of each 4-week intervention arms.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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