Evaluation of Milk Polar Lipids in Dyslipidemic Adults With Abdominal Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05700916
• Other study ID #: H22-0161
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 20, 2023
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: University of Connecticut
• Contact: Christopher N Blesso, Ph.D.
• Phone: 860-486-9049
• Email: christopher.blesso[@]uconn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• LDL-C = 130 mg/dL
• Waist circumference = 88 cm for women, = 102 cm for men
• Aged 40 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
• Self-reported pre-menopausal status
• 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).

Related Conditions & MeSH terms

• Dyslipidemias
• Obesity
• Obesity, Abdominal

Intervention

Drug:
• Milk Polar Lipid-Rich Dairy Powder
Effects of the addition of 6.5 g of milk polar lipids to dairy powder.

Dietary Supplement:
• Dairy Powder
Effects of dairy control powder

Locations

Country	Name	City	State
United States	University of Connecticut	Storrs	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut	Dairy Management Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks