Bioactive Dairy Lipids to Manage Cardiometabolic Risk in Obesity

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Centre de Recherche en Nutrition Humaine Rhône-Alpes
ACTIVE_NOT_RECRUITING
Pierre-bénite
Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition
RECRUITING
Pierre-bénite
Contact Information
Primary
Emmanuel DISSE, Pr
emmanuel.disse@chu-lyon.fr
+33 4 78 86 14 89
Backup
MArie-Caroline MICHALSKI, Dr
marie-caroline.michalski@inrae.fr
+33 4 26 23 61 71
Time Frame
Start Date: 2023-06-28
Estimated Completion Date: 2026-10
Participants
Target number of participants: 75
Treatments
Other: Low-fat dairy products within a dietary handling for weight loss
3 servings/day of low-fat dairy products: 1 serving of low-fat cheese, 1 serving of low-fat yogurt and 1 serving of (semi-)skimmed milk.
Experimental: Whole-fat dairy products within a dietary handling for weight loss
3 servings/day of whole-fat dairy products: 1 serving of whole cheese, 1 serving of whole yogurt and 1 serving of whole milk.
Experimental: Whole-fat dairy products enriched with milk polar lipids within a dietary handling for weight loss
3 servings/day of whole-fat dairy products (1 milk, 1 yogurt, 1 cheese) among which 1 serving/day is enriched with milk polar lipids via butterier.
Related Therapeutic Areas
Sponsors
Collaborators: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Centre de Recherche en Nutrition Humaine Rhone-Alpe, Laboratoire de Recherche en Cardiovasculaire, Métabolisme, Diabétologie et Nutrition
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov