Effects of dairy lipids on weight loss and heart health in obese adults
Bioactive Dairy Lipids to Manage Cardiometabolic Risk in Obesity
This study is testing if eating whole dairy products with special fats can help obese adults lose weight and improve their heart health better than low-fat dairy products.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 2 sites (Pierre-Bénite and 1 other locations) |
| Trial ID | NCT05783466 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18-70 with a BMI between 35 and 60 kg/m2 who consume dairy products regularly.
Not a fit: Patients with a history of bariatric surgery, significant alcohol consumption, or dietary restrictions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary interventions that significantly improve weight loss and metabolic health in individuals with severe obesity.
How similar studies have performed: While there is ongoing research into dietary impacts on obesity, this specific approach of using milk polar lipids is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Pierre-Bénite and 1 other locations
- Centre de Recherche en Nutrition Humaine Rhône-Alpes — Pierre-Bénite, France (Active_not_recruiting)
- Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition — Pierre-Bénite, France (Recruiting)
Study contacts
- Study coordinator: Emmanuel DISSE, Pr
- Email: emmanuel.disse@chu-lyon.fr
- Phone: +33 4 78 86 14 89
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.