Dairy Lipids and Cardiometabolic Risk
Recruiting · NCT05783466 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Low-fat dairy productsMilk polar lipid enriched whole-fat dairy productsWhole-fat dairy products
What this trial 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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
2 locations listed.
- Centre de Recherche en Nutrition Humaine Rhône-Alpes - Pierre-Bénite, France
- Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition - Pierre-Bénite, France