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NCT Number: NCT05700916

Evaluation of Milk Polar Lipids 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Dyslipidemias Body Weight Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Connecticut

Storrs, Connecticut, 06269, United States

About this study

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:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • LDL-C ≥ 130 mg/dL
  • Waist circumference ≥ 88 cm for women, ≥ 102 cm for men
  • Aged 18 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
  • 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).

Treatment and study plan

Milk Polar Lipid-Rich Dairy Powder

Drug

Effects of the addition of 6.5 g of milk polar lipids to dairy powder.

Dairy Powder

Dietary Supplement

Effects of dairy control powder

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Collaborators

  • Dairy Management Inc.

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2023
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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