Evaluation of Milk Polar Lipids in Dyslipidemic Adults With Abdominal Obesity

November 21, 2023 updated by: Christopher Blesso, University of Connecticut

Evaluation of Milk Polar Lipids on Lipoprotein Metabolism, Inflammation, and Gut Microbiota in Dyslipidemic Adults With Abdominal Obesity

The major objective of this project is to examine whether daily consumption of milk polar lipids (MPLs) influences cardiometabolic risk factors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators will conduct a randomized, double-blind, controlled, parallel, intervention study in dyslipidemic adults with abdominal obesity (n = 130). Participants will consume either a control dairy beverage (n = 65) or an MPL-rich dairy beverage (n = 65) for 8 weeks. The investigators plan to evaluate the following 4 specific objectives:

  1. Determine the effects of MPLs on serum lipid concentrations and other cardiometabolic risk factors.
  2. Evaluate the effects of MPLs on systemic biomarkers of low-grade inflammation.
  3. Examine the effects of MPLs on lipoprotein metabolism and lipoprotein particle characteristics.
  4. Evaluate the effects of MPLs on gut microbiota, gut permeability markers, and fecal lipids.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • Storrs, Connecticut, United States, 06269
        • Recruiting
        • University of Connecticut
        • Contact:
        • Principal Investigator:
          • Christopher Blesso, Ph.D.

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

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • LDL-C ≥ 130 mg/dL
  • Waist circumference ≥ 88 cm for women, ≥ 102 cm for men
  • Aged 40 to 70 years

Exclusion Criteria:

  • Renal disease
  • Liver disease
  • Diabetes
  • Heart disease
  • Stroke
  • Cancer
  • Eating disorders
  • Thyroid disease
  • Gut-associated pathologies
  • Autoimmune diseases
  • Chronic inflammatory diseases
  • Scleroderma
  • Gallbladder disease
  • Blood clotting disorders
  • Intravenous drug use
  • Self-reported pre-menopausal status
  • Fasting plasma/serum triglycerides >500 mg/dL
  • Fasting plasma/serum glucose >126 mg/d
  • Weight changes >10% over last 4 weeks
  • Oral antibiotics use up to 1 month prior to and during study
  • Allergy or intolerance to milk products
  • Taking lipid-lowering medications (e.g., statins, fibrates)
  • Taking anti-inflammatory medications (e.g., corticosteroids)
  • Taking medications which primarily affect blood clotting (e.g., warfarin).

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MPL-rich dairy powder
Daily consumption of 50 g of dairy powder containing 6.5 g MPL for 8 weeks.
Drug: Milk Polar Lipid-Rich Dairy Powder
Effects of the addition of 6.5 g of milk polar lipids to dairy powder.
Placebo Comparator: Control dairy powder
Daily consumption of 50 g of dairy powder containing <0.1 g MPL for 8 weeks
Dietary supplement: Dairy Powder
Effects of dairy control powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Serum LDL Cholesterol at 8 weeks
Time Frame: 8 weeks
Measurement of serum LDL cholesterol (mg/dL) at the beginning and end of 8-week intervention arm.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Connecticut

Collaborators

Dairy Management Inc.

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)

October 20, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 18, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H22-0161

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Milk Polar Lipid-Rich Dairy Powder

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe