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
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
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.
Primary outcome measure(s)
Total plasma apolipoprotein B concentration — day 0 and day 90 Change in fasting total plasma apolipoprotein B concentration after 3-month intervention, measured by ELISA.
Trial sites (2)
Facility
City
Region
Status
Centre de Recherche en Nutrition Humaine Rhône-Alpes
Pierre-Bénite
France
Active Not Recruiting
Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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