Recruiting NCT05783466
Dairy Lipids and Cardiometabolic Risk
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low-fat dairy products, Whole-fat dairy products, Milk polar lipid enriched whole-fat dairy products.
- Who it may be relevant to
- Registry conditions: Morbid Obesity. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Bioactive Dairy Lipids to Manage Cardiometabolic Risk in Obesity
Overview
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.
Interventions
- Other Low-fat dairy products
3-month intervention - Other Whole-fat dairy products
3-month intervention - Other Milk polar lipid enriched whole-fat dairy products
3-month intervention
Primary outcome measures
- Total plasma apolipoprotein B concentration [Time frame: day 0 and day 90]
Secondary outcome measures (12)
- Changes in weight [Time frame: day 0 and day 90]
- Anthropometric measurements 2 [Time frame: day 0 and day 90]
- Body mass composition measurements [Time frame: day 0 and day 90]
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods [Time frame: day 0 and day 90 for fasting and postprandial measurements. • For postprandial measurements: times 60 minutes-120 minutes -180 minutes -240 minutes -270 minutes -300 minutes -360 minutes]
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 2 [Time frame: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -180 minutes -240 minutes -270 minutes -300 minutes.]
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 3 [Time frame: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: time 360 minutes.]
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 4 [Time frame: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: time 360 minutes.]
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 5 [Time frame: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes -300 minutes.]
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 6 [Time frame: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes -300 minutes - 360 minutes]
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 7 [Time frame: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements:times 360 minutes.]
- Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 8 [Time frame: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes]
- Glucose concentrations after 3-month intervention, measured using standard laboratory methods [Time frame: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 2 centers
- Centre de Recherche en Nutrition Humaine Rhône-Alpes — Pierre-Bénite
- Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition — Pierre-Bénite
Identifiers
NCT: NCT05783466 · 69HCL22_0461 · 2022-A02415-38