Morbid ObesityDAILICATENCT05783466
Dairy Lipids and Cardiometabolic Risk
A study testing Low-fat dairy products, Whole-fat dairy products and Milk polar lipid enriched whole-fat dairy products in people with Morbid Obesity, run by Hospices Civils de Lyon at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Low-fat dairy products, Whole-fat dairy products and Milk polar lipid enriched whole-fat dairy products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesFrance
- Study dates
- 28 Jun 2023to Oct 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 1 recruiting
- Active, not recruiting
Centre de Recherche en Nutrition Humaine Rhône-Alpes
Pierre-Bénite, 69310
- Recruiting
Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition
Pierre-Bénite, 69310
Emmanuel DISSE, Pr, +33 4 78 86 14 89, emmanuel.disse@chu-lyon.fr
SEGRESTIN Bérénice, Dr
About this study
Official title: Bioactive Dairy Lipids to Manage Cardiometabolic Risk in Obesity
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.
- Conditions
- Morbid Obesity
- Being tested
- Low-fat dairy products, Whole-fat dairy products, Milk polar lipid enriched whole-fat dairy products
- Keywords
- Obesity, Nutrition, Dietary intervention, Weight loss, Metabolism, Dairy, Fat, Milk polar lipids
- Medical subject headings
- Obesity, Morbid, Obesity, Weight Loss, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-fat dairy productsOther
3-month intervention
Whole-fat dairy productsOther
3-month intervention
Milk polar lipid enriched whole-fat dairy productsOther
3-month intervention
| Study group | Role | What they receive |
|---|---|---|
| Low-fat dairy products within a dietary handling for weight loss | Other | 3 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. Receives: Other: Low-fat dairy products |
| Whole-fat dairy products within a dietary handling for weight loss | Experimental | 3 servings/day of whole-fat dairy products: 1 serving of whole cheese, 1 serving of whole yogurt and 1 serving of whole milk. Receives: Other: Whole-fat dairy products |
| Whole-fat dairy products enriched with milk polar lipids within a dietary handling for weight loss | Experimental | 3 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. Receives: Other: Milk polar lipid enriched whole-fat dairy products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total plasma apolipoprotein B concentration
Change in fasting total plasma apolipoprotein B concentration after 3-month intervention, measured by ELISA.
Measured: day 0 and day 90
Secondary outcomes (42)
Changes in weight
Changes in weight after 3-month intervention.
Measured: day 0 and day 90
Anthropometric measurements 2
Changes in waist and hip circumferences after 3-month intervention.
Measured: day 0 and day 90
Body mass composition measurements
Change in body mass composition (lean mass, fat mass) after 3-month intervention, analyzed by impedancemeter
Measured: day 0 and day 90
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods
Changes in plasma concentrations of triglycerides
Measured: 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
Changes in plasma concentrations of total cholesterol
Measured: 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
Changes in plasma concentrations of LDL-cholesterol
Measured: 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
Changes in plasma concentrations of HDL-cholesterol
Measured: 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
Changes in plasma concentrations of apoB100
Measured: 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
Changes in plasma concentrations of apoB48
Measured: 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
Changes in plasma concentrations of apoA1
Measured: 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
Changes in plasma concentrations of unesterified fatty acids
Measured: 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
Changes in plasma concentrations of glucose
Measured: 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 2
Changes in plasma concentrations of insulin
Measured: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes
Targeted plasma lipidomics after 3-month intervention
Changes in plasma concentrations of phospholipids
Measured: day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
Targeted plasma lipidomics after 3-month intervention 2
Changes in plasma concentrations of sphingolipids (sphingomyelins and ceramides)
Measured: day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
Targeted plasma lipidomics after 3-month intervention 3
Changes in plasma concentrations of lysophospholipids
Measured: day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
Targeted plasma lipidomics after 3-month intervention 4
Changes in plasma concentrations of fatty acids in plasma total lipids
Measured: day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
Targeted plasma lipidomics after 3-month intervention 5
Changes in plasma concentrations of phospholipids
Measured: day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
Targeted chylomicrons of plasma after 3-month intervention
Changes in concentrations of triglycerides
Measured: day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
Targeted chylomicrons of plasma after 3-month intervention 2
Changes in concentrations of cholesterol
Measured: day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
Targeted chylomicrons of plasma after 3-month intervention 3
Changes in concentrations of sphingolipids
Measured: day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
Targeted chylomicrons of plasma after 3-month intervention 4
Changes in concentrations of fatty acids
Measured: day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
Inflammation markers
Changes in adiponectin
Measured: day 0 and day 90 for fasting and postprandial measurements.
Inflammation markers 2
Changes in CRP
Measured: day 0 and day 90 for fasting and postprandial measurements.
Inflammation markers 3
Changes in cytokines
Measured: day 0 and day 90 for fasting and postprandial measurements.
Inflammation markers 4
Changes in LBP
Measured: day 0 and day 90 for fasting and postprandial measurements.
Inflammation markers 5
Changes in endotoxins
Measured: day 0 and day 90 for fasting and postprandial measurements.
Inflammation markers 6
Changes in CD14
Measured: day 0 and day 90 for fasting and postprandial measurements.
Inflammation markers 7
Gene expressions of inflammation markers after 3-month intervention, measured with dedicated kits and PAXgene kit
Measured: day 0 and day 90 for fasting and postprandial measurements.
Platelet activation markers
Changes in thromboxane B2 concentrations in platelets (from blood donors) stimulated by lipoproteins (chylomicrons and HDL) after 3-month intervention, measured with an ELISA kit.
Differences in the percents of aggregation of platelets incubated with lipoproteins (chylomicrons and HDL) after 3-month intervention, assessed by light transmission aggregometry.
Measured: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements,times 120 minutes-240 minutes-300 minutes -360 minutes.
Oxidative stress marker
Changes in urinary concentrations of 8-iso-PGF2 alpha isoprostane after 3-month intervention, determined with an ELISA kit
Measured: day 0 and day 90
Markers of immune cells
PBMC
Measured: day 0 and day 90
Markers of immune cells 2
Complete blood counts
Measured: day 0 and day 90
Intestinal microbiota after 3-month intervention.
Changes in microbiome composition and diversity (alpha, beta) of feces (16S analysis)
Measured: day 0 and day 90
Intestinal microbiota after 3-month intervention 2
Changes in fecal concentrations of microbiota-derived metabolites (coprostanol, short chain fatty acids (SCFA), calprotectin)
Measured: day 0 and day 90
Questionnaires on physical activity
International Physical Activity Questionnaire ([i] ëinactive, [ii] ëminimally active, [iii] ëHEPA activeí (health enhancing physical activity; a high active category).)
Measured: day 0 and day 90
Questionnaires on digestive comfort
Liker scale
Measured: day 0 and day 90
Questionnaires on digestive comfort
Bristol stool scale
Measured: day 0 and day 90
Questionnaires on product satiety
Satiety from visual analog scale (VAS)
Measured: day 0 and day 90
Questionnaires food intake
Three-factor eating questionnaire (TFEQ)
Measured: day 0 and day 90
Questionnaires on product appreciation
Product appreciation questionnaire
Measured: day 0 and day 90
Dietary intake questionnaire
Dietary record questionnaire
Measured: day 0 and day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start28 Jun 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire de Recherche en Cardiovasculaire, Métabolisme, Diabétologie et Nutrition, Centre de Recherche en Nutrition Humaine Rhone-Alpe, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783466
- Sponsor's protocol ID
- 69HCL22_0461
- Other IDs
- 2022-A02415-38
- Acronym
- DAILICATE
- Status last verified
- Jun 2025
- First submitted
- 16 Feb 2023
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No