Dairy Lipids and Cardiometabolic Risk

Recruiting now · Not applicable

Conditions studied: Morbid Obesity

In brief

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.

Key facts

Study ID

NCT05783466

Run by

Hospices Civils de Lyon

People needed

75

Starts

2023-06-28

Expected to finish

2026-10-01

Last updated by the study team

2025-06-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women between 18-70 years
• Body Mass Index (BMI) between 35 and 60 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

You may not qualify if…

• 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.

Where it is running

• Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition — Pierre-Bénite, France (enrolling)
• Centre de Recherche en Nutrition Humaine Rhône-Alpes — Pierre-Bénite, France

Full record on ClinicalTrials.gov

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