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Evaluation of Milk Polar Lipids in Dyslipidemic Adults With Abdominal Obesity
The major objective of this project is to examine whether daily consumption of milk polar lipids (MPLs) influences cardiometabolic risk factors.
Conditions:
🦠 Dyslipidemias 🦠 Obesity
🗓️ Study Start (Actual) 20 October 2023
🗓️ Primary Completion (Estimated) December 2025
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 130
🔬 Study Type INTERVENTIONAL
📊 Phase EARLY_PHASE1
Locations:
📍 Storrs, Connecticut, United States

📋 Eligibility Criteria

Description

    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).
Ages Eligible for Study: 18 Years to 70 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 January 2023
  • First Submitted that Met QC Criteria 18 January 2023
  • First Posted 26 January 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 7 June 2024
  • Last Update Posted 10 June 2024
  • Last Verified June 2024
I'm interested ...!!