Dairy Lipids and Cardiometabolic Risk (DAILICATE)

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.

Study Overview

• Status: Recruiting
• Conditions: Morbid Obesity
• Intervention / Treatment: Other: Low-fat dairy products; Other: Whole-fat dairy products; Other: Milk polar lipid enriched whole-fat dairy products

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emmanuel DISSE, Pr; Phone Number: +33 4 78 86 14 89; Email: emmanuel.disse@chu-lyon.fr
• Study Contact Backup: Name: MArie-Caroline MICHALSKI, Dr; Phone Number: +33 4 26 23 61 71; Email: marie-caroline.michalski@inrae.fr

Study Locations

• France
  • Pierre-Bénite, France, 69310
    • Active, not recruiting
    • Centre de recherche en nutrition humaine Rhone-Alpes
  • Pierre-Bénite, France, 69310
    • Recruiting
    • Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition
    • Contact: Emmanuel DISSE, Pr; Phone Number: +33 4 78 86 14 89; Email: emmanuel.disse@chu-lyon.fr
    • Sub-Investigator: SEGRESTIN Bérénice, Dr
    • Sub-Investigator: RAJOT Amélie, Dr
    • Sub-Investigator: CAUSSY Cyrielle, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Low-fat dairy products within a dietary handling for weight loss; 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.	Other: Low-fat dairy products; 3-month intervention
Experimental: Whole-fat dairy products within a dietary handling for weight loss; 3 servings/day of whole-fat dairy products: 1 serving of whole cheese, 1 serving of whole yogurt and 1 serving of whole milk.	Other: Whole-fat dairy products; 3-month intervention
Experimental: Whole-fat dairy products enriched with milk polar lipids within a dietary handling for weight loss; 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.	Other: Milk polar lipid enriched whole-fat dairy products; 3-month intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in weight	Changes in weight after 3-month intervention.	day 0 and day 90
Anthropometric measurements 2	Changes in waist and hip circumferences after 3-month intervention.	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	day 0 and day 90
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods	Changes in plasma concentrations of triglycerides	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	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	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	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	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	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	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	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	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	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	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)	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	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	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	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	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	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	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	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	day 0 and day 90 for fasting and postprandial measurements.
Inflammation markers 2	Changes in CRP	day 0 and day 90 for fasting and postprandial measurements.
Inflammation markers 3	Changes in cytokines	day 0 and day 90 for fasting and postprandial measurements.
Inflammation markers 4	Changes in LBP	day 0 and day 90 for fasting and postprandial measurements.
Inflammation markers 5	Changes in endotoxins	day 0 and day 90 for fasting and postprandial measurements.
Inflammation markers 6	Changes in CD14	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	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.	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	day 0 and day 90
Markers of immune cells	PBMC	day 0 and day 90
Markers of immune cells 2	Complete blood counts	day 0 and day 90
Intestinal microbiota after 3-month intervention.	Changes in microbiome composition and diversity (alpha, beta) of feces (16S analysis)	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)	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).)	day 0 and day 90
Questionnaires on digestive comfort	Liker scale	day 0 and day 90
Questionnaires on digestive comfort	Bristol stool scale	day 0 and day 90
Questionnaires on product satiety	Satiety from visual analog scale (VAS)	day 0 and day 90
Questionnaires food intake	Three-factor eating questionnaire (TFEQ)	day 0 and day 90
Questionnaires on product appreciation	Product appreciation questionnaire	day 0 and day 90
Dietary intake questionnaire	Dietary record questionnaire	day 0 and day 90

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• 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

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Nutrition; Weight loss; Dairy; Fat; Metabolism; Dietary intervention; Milk polar lipids
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 69HCL22_0461; 2022-A02415-38 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No