Evaluation of Milk Polar Lipids in Dyslipidemic Adults With Abdominal Obesity

Early Phase 1RecruitingNCT05700916

University of Connecticut130 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

130

Conditions

Dyslipidemias Obesity

Interventions

Milk Polar Lipid-Rich Dairy PowderDRUG

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

Dairy PowderDIETARY_SUPPLEMENT

Effects of dairy control powder

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

University of Connecticut

Storrs, Connecticut, United States

RECRUITING

Outcomes

Primary Outcomes

Change from Baseline Serum LDL Cholesterol at 8 weeks

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

Time frame: 8 weeks

Central Contacts

Christopher N Blesso, Ph.D.

CONTACT

860-486-9049 christopher.blesso@uconn.edu

Data from ClinicalTrials.gov

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