Dairy Lipids and Cardiometabolic Risk
NCT05783466
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
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.
Conditions2
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NCT05783466