Clinical trial

Dairy Lipids and Cardiometabolic Risk

Recruiting now · Not applicable · 1 countries · Registry ID NCT05783466

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years
SexAll
Healthy volunteersNot accepted
ConditionMorbid Obesity

Full registry criteria

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.

Treatments and study arms

Low-fat dairy products

Other

3-month intervention

Whole-fat dairy products

Other

3-month intervention

Milk polar lipid enriched whole-fat dairy products

Other

3-month intervention

Primary outcomes

Total plasma apolipoprotein B concentrationday 0 and day 90

Change in fasting total plasma apolipoprotein B concentration after 3-month intervention, measured by ELISA.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Centre de Recherche en Nutrition Humaine Rhône-Alpes🇫🇷 Pierre-Bénite, France
Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition🇫🇷 Pierre-Bénite, France
Emmanuel DISSE, PrContact
SEGRESTIN Bérénice, DrSub Investigator
RAJOT Amélie, DrSub Investigator