Evaluation of Milk Polar Lipids in Dyslipidemic Adults With Abdominal Obesity

Early Phase 1

Recruiting

• Conditions: Dyslipidemias; Obesity
• Interventions: Drug: Milk Polar Lipid-Rich Dairy Powder; Dietary Supplement: Dairy Powder

• Registration Number: NCT05700916
• Lead Sponsor: University of Connecticut

Brief 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.

Study Timeline

• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-26
• Study Start: 2023-10-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MPL-rich dairy powder	Milk Polar Lipid-Rich Dairy Powder	Daily consumption of 50 g of dairy powder containing 6.5 g MPL for 8 weeks.
Control dairy powder	Dairy Powder	Daily consumption of 50 g of dairy powder containing \<0.1 g MPL for 8 weeks

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Connecticut; 🇺🇸 Storrs, Connecticut, United States