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
- Are there results?
- Not yet: the study is under way
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
Show all 10Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioactive Dairy Lipids to Manage Cardiometabolic Risk in Obesity
- ClinicalTrials.gov ID
- NCT05783466
- Acronym / sponsor ID
- DAILICATE / 69HCL22_0461
- Conditions
- Morbid Obesity
- Keywords
- Obesity, Nutrition, Dietary intervention, Weight loss, Metabolism, Dairy, Fat, Milk polar lipids
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, 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
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-fat dairy products within a dietary handling for weight loss | Other | Other: Low-fat dairy products3 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 | Experimental | Other: Whole-fat dairy products3 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 | Experimental | Other: Milk polar lipid enriched whole-fat dairy products3 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-fat dairy products3-month intervention | Other | Low-fat dairy products within a dietary handling for weight loss |
| Whole-fat dairy products3-month intervention | Other | Whole-fat dairy products within a dietary handling for weight loss |
| Milk polar lipid enriched whole-fat dairy products3-month intervention | Other | Whole-fat dairy products enriched with milk polar lipids within a dietary handling for weight loss |
Primary outcome
Total plasma apolipoprotein B concentration
Time frame: day 0 and day 90
Change in fasting total plasma apolipoprotein B concentration after 3-month intervention, measured by ELISA.
42 secondary outcomes
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
Glucose 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 -240 minutes
Targeted plasma lipidomics after 3-month intervention
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
Inflammation markers
Time frame: day 0 and day 90 for fasting and postprandial measurements.
Inflammation markers 2
Time frame: day 0 and day 90 for fasting and postprandial measurements.
Inflammation markers 3
Time frame: day 0 and day 90 for fasting and postprandial measurements.
Inflammation markers 4
Time frame: day 0 and day 90 for fasting and postprandial measurements.
Inflammation markers 5
Time frame: day 0 and day 90 for fasting and postprandial measurements.
Inflammation markers 6
Time frame: day 0 and day 90 for fasting and postprandial measurements.
Inflammation markers 7
Time frame: day 0 and day 90 for fasting and postprandial measurements.
Platelet activation markers
Time frame: 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
Time frame: day 0 and day 90
Markers of immune cells
Time frame: day 0 and day 90
Markers of immune cells 2
Time frame: day 0 and day 90
Intestinal microbiota after 3-month intervention.
Time frame: day 0 and day 90
Intestinal microbiota after 3-month intervention 2
Time frame: day 0 and day 90
Questionnaires on physical activity
Time frame: day 0 and day 90
Questionnaires on digestive comfort
Time frame: day 0 and day 90
Questionnaires on digestive comfort
Time frame: day 0 and day 90
Questionnaires on product satiety
Time frame: day 0 and day 90
Questionnaires food intake
Time frame: day 0 and day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Morbid Obesity
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel DISSE, Pr (+33 4 78 86 14 89, emmanuel.disse@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total plasma apolipoprotein B concentration (time frame: day 0 and day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.