Evaluating the effects of milk polar lipids on heart health in adults with obesity
Evaluation of Milk Polar Lipids on Lipoprotein Metabolism, Inflammation, and Gut Microbiota in Dyslipidemic Adults With Abdominal Obesity
This study is testing whether drinking a special dairy beverage with milk polar lipids can improve heart health in adults with obesity and high cholesterol over 8 weeks.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Connecticut Academic / other |
| Locations | 1 site (Storrs, Connecticut) |
| Trial ID | NCT05700916 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of daily consumption of milk polar lipids (MPLs) on cardiometabolic risk factors in dyslipidemic adults with abdominal obesity. It is a randomized, double-blind, controlled trial involving 130 participants who will consume either an MPL-rich dairy beverage or a control dairy beverage for 8 weeks. The study aims to assess changes in serum lipid concentrations, low-grade inflammation biomarkers, lipoprotein metabolism, and gut microbiota. The findings could provide insights into the potential health benefits of MPLs in managing obesity-related conditions.
Who should consider this trial
Good fit: Ideal candidates are dyslipidemic adults aged 18 to 70 with abdominal obesity and elevated LDL cholesterol levels.
Not a fit: Patients with significant comorbidities such as diabetes, heart disease, or those on lipid-lowering medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new dietary recommendations for improving heart health and managing obesity-related dyslipidemias.
How similar studies have performed: While the specific use of milk polar lipids is novel, similar dietary interventions have shown promise in improving cardiometabolic health.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Storrs, Connecticut
- University of Connecticut — Storrs, Connecticut, United States (Recruiting)
Study contacts
- Study coordinator: Christopher N Blesso, Ph.D.
- Email: christopher.blesso@uconn.edu
- Phone: 860-486-9049
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.