NCT05783466Recruiting
Dairy Lipids and Cardiometabolic Risk
Bioactive Dairy Lipids to Manage Cardiometabolic Risk in Obesity
Source: ClinicalTrials.gov · Last updated 18 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 16 Feb 2023
- Start date
- 28 Jun 2023
- Primary completion date
- Oct 2026
- Lead sponsor
- Hospices Civils de Lyon
- Diseases
- Obesity
- NCT number
- NCT05783466
What you commit to
- Study type: Interventional
- Planned participants: 75
- From 28 Jun 2023 to the primary completion date, Oct 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- History of bariatric or digestive surgery or disease interfering with main outcomes
- Food allergies or intolerance to dairy products
Other
- Drinking more than 3 glasses of alcohol per day (\>30g/day)
- Pregnancy, parturiency or breastfeeding
- Dietary restriction (vegetarian or lactovegetarian) or high protein diet
- Use of dietary supplements
- Smoking ≥ 5 cigarettes/day during the past 6 months.
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre de Recherche en Nutrition Humaine Rhone-Alpes Coordinator of this site? Confirm its status | Pierre-Bénite | France | Active, not recruiting |
| Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.