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

Gut Microbiome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04208815
• Other study ID #: H19-122
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: January 2022
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Gut Microbiome
• Serum Cholesterol

Intervention

Other:
• Milk Polar Lipids
Effects of the addition of 5 g of milk polar lipids to 20 g milk fat.
• Milk Fat
Effects of the addition of 20 g milk fat.

Locations

Country	Name	City	State
United States	University of Connecticut	Storrs	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
University of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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