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Evaluation of Milk Polar Lipids in Dyslipidemic Adults With Abdominal Obesity

Sponsor
University of Connecticut (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05700916
Collaborator
Dairy Management Inc. (Industry)
130
Enrollment
1
Location
2
Arms
34
Anticipated Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Milk Polar Lipid-Rich Dairy Powder
  • Other: Dairy Powder
 Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Evaluation of Milk Polar Lipids on Lipoprotein Metabolism, Inflammation, and Gut Microbiota in Dyslipidemic Adults With Abdominal Obesity
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: MPL-rich dairy powder

Daily consumption of 50 g of dairy powder containing 6.5 g MPL for 8 weeks.

Dietary Supplement: 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

Other: Dairy Powder
Effects of dairy control powder

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline Serum LDL Cholesterol at 8 weeks [8 weeks]

    Measurement of serum LDL cholesterol (mg/dL) at the beginning and end of 8-week intervention arm.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Connecticut Storrs Connecticut United States 06269

Sponsors and Collaborators

  • University of Connecticut
  • Dairy Management Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christopher Blesso, Associate Professor, University of Connecticut
ClinicalTrials.gov Identifier:
NCT05700916
Other Study ID Numbers:
  • H22-0161
First Posted:
Jan 26, 2023
Last Update Posted:
Jan 26, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Obesity
Dyslipidemias
Obesity, Abdominal

Study Results

No Results Posted as of Jan 26, 2023