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Dairy Lipids and Cardiometabolic Risk

Dairy Lipids and Cardiometabolic Risk

Recruiting
18-50 years
All
Phase N/A

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Overview

It is a randomized parallel arm intervention study in adults with severe obesity. The objective is to demonstrate that within a dietary handling for weight loss, the daily ingestion during 3 months of whole dairy products enriched with milk polar lipids or whole dairy products decreases to a greater extent fasting plasma apolipoprotein B concentrations than the daily ingestion of low-fat dairy products (control group).

Metabolic parameters will be assessed before and after the 3-month intervention, both at fasting and in postprandial period after the consumption of standardized meals.

Eligibility

Inclusion Criteria:

  • Men and women between 18-70 years
  • Body Mass Index (BMI) between 40 and 55 kg/m2 inclusive
  • Stable body weight (weight change +/- 5 % for 3 months prior to screening)
  • Consumption of at least 1 serving/day of dairy products made from cow's milk
  • Informed consent

Exclusion Criteria:

  • History of bariatric or digestive surgery or disease interfering with main outcomes
  • Drinking more than 3 glasses of alcohol per day (>30g/day)
  • Pregnancy, parturiency or breastfeeding
  • Food allergies or intolerance to dairy products
  • Dietary restriction (vegetarian or lactovegetarian) or high protein diet
  • Use of dietary supplements
  • Treated with lipid lowering drugs (fibrates, statins, anti-PCSK9, ezetimibe, cholestyramine) within the last 6 weeks before study entry
  • Treated with insulin, GLP-1 analogs, acarbose, corticoids, beta-blockers.
  • Medications interfering with intestinal microbiota (beta-lactamines within 3 months before the study or laxatives)
  • Smoking ≥ 5 cigarettes/day during the past 6 months.

Study details
    Morbid Obesity

NCT05783466

Hospices Civils de Lyon

26 January 2024

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