Dairy Lipids and Cardiometabolic Risk
DAILICATE
Bioactive Dairy Lipids to Manage Cardiometabolic Risk in Obesity
2 other identifiers
interventional
75
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2023
CompletedFirst Posted
Study publicly available on registry
March 24, 2023
CompletedStudy Start
First participant enrolled
June 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
June 18, 2025
June 1, 2025
3.3 years
February 16, 2023
June 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total plasma apolipoprotein B concentration
Change in fasting total plasma apolipoprotein B concentration after 3-month intervention, measured by ELISA.
day 0 and day 90
Secondary Outcomes (42)
Changes in weight
day 0 and day 90
Anthropometric measurements 2
day 0 and day 90
Body mass composition measurements
day 0 and day 90
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods
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
day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -180 minutes -240 minutes -270 minutes -300 minutes.
- +37 more secondary outcomes
Study Arms (3)
Low-fat dairy products within a dietary handling for weight loss
OTHER3 servings/day of low-fat dairy products: 1 serving of low-fat cheese, 1 serving of low-fat yogurt and 1 serving of (semi-)skimmed milk.
Whole-fat dairy products within a dietary handling for weight loss
EXPERIMENTAL3 servings/day of whole-fat dairy products: 1 serving of whole cheese, 1 serving of whole yogurt and 1 serving of whole milk.
Whole-fat dairy products enriched with milk polar lipids within a dietary handling for weight loss
EXPERIMENTAL3 servings/day of whole-fat dairy products (1 milk, 1 yogurt, 1 cheese) among which 1 serving/day is enriched with milk polar lipids via butterier.
Interventions
3-month intervention
3-month intervention
3-month intervention
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centre de Recherche en Nutrition Humaine Rhône-Alpes
Pierre-Bénite, 69310, France
Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition
Pierre-Bénite, 69310, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2023
First Posted
March 24, 2023
Study Start
June 28, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
June 18, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share