NCT05700916 Evaluation of Milk Polar Lipids in Dyslipidemic Adults With Abdominal Obesity
| NCT ID | NCT05700916 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Connecticut |
| Condition | Dyslipidemias |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2023-10-20 |
| Primary Completion | 2026-05 |
Trial Parameters
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Brief Summary
The major objective of this project is to examine whether daily consumption of milk polar lipids (MPLs) influences cardiometabolic risk factors.
Eligibility 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).