Evaluation of Milk Polar Lipids in Dyslipidemic Adults With Abdominal Obesity

University of Connecticut

Status and phase: Enrolling; Early Phase 1

Conditions: Dyslipidemias; Obesity

Treatments: Dietary Supplement: Dairy Powder; Drug: Milk Polar Lipid-Rich Dairy Powder

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05700916

H22-0161

Details and patient eligibility

About

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

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

130 participants in 2 patient groups, including a placebo group

MPL-rich dairy powder

Experimental group

Description:

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

Treatment:

Drug: Milk Polar Lipid-Rich Dairy Powder

Control dairy powder

Placebo Comparator group

Description:

Daily consumption of 50 g of dairy powder containing \<0.1 g MPL for 8 weeks

Treatment:

Dietary Supplement: Dairy Powder