Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05783466

Dairy Lipids and Cardiometabolic Risk

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Morbid Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Platelet Glycoprotein IV Deficiency Signs and Symptoms Weight Loss

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Recherche en Nutrition Humaine Rhône-Alpes, Pierre-Bénite, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-fat dairy products

Other

3-month intervention

Whole-fat dairy products

Other

3-month intervention

Milk polar lipid enriched whole-fat dairy products

Other

3-month intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes in weight

    Time frame: day 0 and day 90

    Changes in weight after 3-month intervention.

  2. Anthropometric measurements 2

    Time frame: day 0 and day 90

    Changes in waist and hip circumferences after 3-month intervention.

  3. Body mass composition measurements

    Time frame: day 0 and day 90

    Change in body mass composition (lean mass, fat mass) after 3-month intervention, analyzed by impedancemeter

  4. 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

    Changes in plasma concentrations of triglycerides

  5. 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.

    Changes in plasma concentrations of total cholesterol

  6. 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.

    Changes in plasma concentrations of LDL-cholesterol

  7. 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.

    Changes in plasma concentrations of HDL-cholesterol

  8. 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.

    Changes in plasma concentrations of apoB100

  9. 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

    Changes in plasma concentrations of apoB48

  10. 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.

    Changes in plasma concentrations of apoA1

  11. 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

    Changes in plasma concentrations of unesterified fatty acids

  12. 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

    Changes in plasma concentrations of glucose

  13. 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

    Changes in plasma concentrations of insulin

  14. 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.

    Changes in plasma concentrations of phospholipids

  15. 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.

    Changes in plasma concentrations of sphingolipids (sphingomyelins and ceramides)

  16. 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.

    Changes in plasma concentrations of lysophospholipids

  17. 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.

    Changes in plasma concentrations of fatty acids in plasma total lipids

  18. 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.

    Changes in plasma concentrations of phospholipids

  19. 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.

    Changes in concentrations of triglycerides

  20. 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.

    Changes in concentrations of cholesterol

  21. 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.

    Changes in concentrations of sphingolipids

  22. 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.

    Changes in concentrations of fatty acids

  23. Inflammation markers

    Time frame: day 0 and day 90 for fasting and postprandial measurements.

    Changes in adiponectin

  24. Inflammation markers 2

    Time frame: day 0 and day 90 for fasting and postprandial measurements.

    Changes in CRP

  25. Inflammation markers 3

    Time frame: day 0 and day 90 for fasting and postprandial measurements.

    Changes in cytokines

  26. Inflammation markers 4

    Time frame: day 0 and day 90 for fasting and postprandial measurements.

    Changes in LBP

  27. Inflammation markers 5

    Time frame: day 0 and day 90 for fasting and postprandial measurements.

    Changes in endotoxins

  28. Inflammation markers 6

    Time frame: day 0 and day 90 for fasting and postprandial measurements.

    Changes in CD14

  29. Inflammation markers 7

    Time frame: day 0 and day 90 for fasting and postprandial measurements.

    Gene expressions of inflammation markers after 3-month intervention, measured with dedicated kits and PAXgene kit

  30. 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.

    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.

  31. Oxidative stress marker

    Time frame: day 0 and day 90

    Changes in urinary concentrations of 8-iso-PGF2 alpha isoprostane after 3-month intervention, determined with an ELISA kit

  32. Markers of immune cells

    Time frame: day 0 and day 90

    PBMC

  33. Markers of immune cells 2

    Time frame: day 0 and day 90

    Complete blood counts

  34. Intestinal microbiota after 3-month intervention.

    Time frame: day 0 and day 90

    Changes in microbiome composition and diversity (alpha, beta) of feces (16S analysis)

  35. Intestinal microbiota after 3-month intervention 2

    Time frame: day 0 and day 90

    Changes in fecal concentrations of microbiota-derived metabolites (coprostanol, short chain fatty acids (SCFA), calprotectin)

  36. Questionnaires on physical activity

    Time frame: day 0 and day 90

    International Physical Activity Questionnaire ([i] ëinactive, [ii] ëminimally active, [iii] ëHEPA activeí (health enhancing physical activity; a high active category).)

  37. Questionnaires on digestive comfort

    Time frame: day 0 and day 90

    Liker scale

  38. Questionnaires on digestive comfort

    Time frame: day 0 and day 90

    Bristol stool scale

  39. Questionnaires on product satiety

    Time frame: day 0 and day 90

    Satiety from visual analog scale (VAS)

  40. Questionnaires food intake

    Time frame: day 0 and day 90

    Three-factor eating questionnaire (TFEQ)

  41. Questionnaires on product appreciation

    Time frame: day 0 and day 90

    Product appreciation questionnaire

  42. Dietary intake questionnaire

    Time frame: day 0 and day 90

    Dietary record questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuel DISSE, Pr

CONTACT

[email protected]

+33 4 78 86 14 89

MArie-Caroline MICHALSKI, Dr

CONTACT

[email protected]

+33 4 26 23 61 71

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Collaborators

  • Centre de Recherche en Nutrition Humaine Rhone-Alpe
  • Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
  • Laboratoire de Recherche en Cardiovasculaire, Métabolisme, Diabétologie et Nutrition

Registry information

Official study title

Bioactive Dairy Lipids to Manage Cardiometabolic Risk in Obesity

Acronym: DAILICATE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2023
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.