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

NCT04208815 | Completed

• 1 other identifier: H19-122
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Serum Cholesterol; Gut Microbiome

Keywords

Milk; Polar Lipids; Phospholipids; Cholesterol; Microbiota; Microbiome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Fecal Microbiota Shannon Index at 4 weeks

  4 weeks

Study Arms (2)

MPL-rich dairy beverage

EXPERIMENTAL

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

Other: Milk Polar Lipids; Other: Milk Fat

Control dairy beverage

PLACEBO COMPARATOR

Daily consumption of 100 g of dairy powder containing 0.3 g MPL for 4 weeks

Other: Milk Fat

Interventions

Milk Polar Lipids OTHER

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

MPL-rich dairy beverage

Milk Fat OTHER

Effects of the addition of 20 g milk fat.

Control dairy beverage; MPL-rich dairy beverage

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Connecticut: lead

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 23, 2019
• Study Start: March 1, 2020
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: January 13, 2022

Record last verified: 2022-01

Locations

US (1)