Effects of dairy lipids on weight loss and heart health in obese adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized intervention focusing on adults with severe obesity, aiming to compare the effects of whole dairy products enriched with milk polar lipids against low-fat dairy products on fasting plasma apolipoprotein B concentrations over a 3-month period. Participants will consume specified dairy products daily while metabolic parameters will be assessed before and after the intervention. The study seeks to determine if whole dairy products can lead to greater improvements in cardiometabolic risk factors compared to low-fat options.

Why it matters

Who can join: the full rules

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's running

• Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition
  Pierre-Bénite, France Recruiting
• Centre de Recherche en Nutrition Humaine Rhône-Alpes
  Pierre-Bénite, France Active not recruiting

Study contacts

• Study coordinator: Emmanuel DISSE, Pr
• Email: emmanuel.disse@chu-lyon.fr
• Phone: +33 4 78 86 14 89

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.