NCT05700916EARLY_PHASE1RecruitingAccepts Healthy Volunteers

Evaluation of Milk Polar Lipids in Dyslipidemic Adults With Abdominal Obesity

University of Connecticut

Start Date

10/20/2023

Completion Date

6/1/2026

Summary

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

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.

Eligibility Criteria

Age Range: 18 years to 70 years

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).

Interventions

DRUG

Milk Polar Lipid-Rich Dairy Powder

DIETARY_SUPPLEMENT

Dairy Powder

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Conditions

DyslipidemiasObesity

Locations

University of Connecticut

Storrs, Connecticut 06269

United States