Dairy Lipids and Cardiometabolic Risk
ConditionMorbid Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHospices Civils de Lyon
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Low-fat dairy products
- Whole-fat dairy products
- Milk polar lipid enriched whole-fat dairy products
Treatment groups
75 Participants
are divided into 3 treatment groupsSponsors and collaborators
Hospices Civils de Lyon
Lead sponsor
Laboratoire de Recherche en Cardiovasculaire, Métabolisme, Diabétologie et Nutrition
Collaborator
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Collaborator
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Collaborator
Source ClinicalTrials.gov