RecruitingNot ApplicableNCT05783466

Dairy Lipids and Cardiometabolic Risk

Bioactive Dairy Lipids to Manage Cardiometabolic Risk in Obesity

Sponsor

Hospices Civils de Lyon

Enrollment

75 participants

Start Date

Jun 28, 2023

Study Type

INTERVENTIONAL

Conditions

Morbid Obesity

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

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 Criteria10

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.