Back to resultsDairy Lipids and Cardiometabolic Risk (DAILICATE)
Primary Purpose
Morbid Obesity
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Low-fat dairy products
Whole-fat dairy products
Milk polar lipid enriched whole-fat dairy products
Sponsored by
About this trial
This is an interventional other trial for Morbid Obesity focused on measuring Obesity, Nutrition, Dietary intervention, Weight loss, Metabolism, Dairy, Fat, Milk polar lipids
Eligibility Criteria
Inclusion Criteria: Men and women between 18-70 years Body Mass Index (BMI) between 40 and 55 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.
Sites / Locations
- Centre de Recherche en Nutrition Humaine Rhône-Alpes
- Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-NutritionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Experimental
Arm Label
Low-fat dairy products within a dietary handling for weight loss
Whole-fat dairy products within a dietary handling for weight loss
Whole-fat dairy products enriched with milk polar lipids within a dietary handling for weight loss
Arm Description
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.
3 servings/day of whole-fat dairy products: 1 serving of whole cheese, 1 serving of whole yogurt and 1 serving of whole milk.
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.
Outcomes
Primary Outcome Measures
Total plasma apolipoprotein B concentration
Change in fasting total plasma apolipoprotein B concentration after 3-month intervention, measured by ELISA.
Secondary Outcome Measures
Changes in weight
Changes in weight after 3-month intervention.
Anthropometric measurements 2
Changes in waist and hip circumferences after 3-month intervention.
Body mass composition measurements
Change in body mass composition (lean mass, fat mass) after 3-month intervention, analyzed by impedancemeter
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods
Changes in plasma concentrations of triglycerides
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 2
Changes in plasma concentrations of total cholesterol
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 3
Changes in plasma concentrations of LDL-cholesterol
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 4
Changes in plasma concentrations of HDL-cholesterol
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 5
Changes in plasma concentrations of apoB100
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 6
Changes in plasma concentrations of apoB48
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 7
Changes in plasma concentrations of apoA1
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 8
Changes in plasma concentrations of unesterified fatty acids
Glucose concentrations after 3-month intervention, measured using standard laboratory methods
Changes in plasma concentrations of glucose
Glucose concentrations after 3-month intervention, measured using standard laboratory methods 2
Changes in plasma concentrations of insulin
Targeted plasma lipidomics after 3-month intervention
Changes in plasma concentrations of phospholipids
Targeted plasma lipidomics after 3-month intervention 2
Changes in plasma concentrations of sphingolipids (sphingomyelins and ceramides)
Targeted plasma lipidomics after 3-month intervention 3
Changes in plasma concentrations of lysophospholipids
Targeted plasma lipidomics after 3-month intervention 4
Changes in plasma concentrations of fatty acids in plasma total lipids
Targeted plasma lipidomics after 3-month intervention 5
Changes in plasma concentrations of phospholipids
Targeted chylomicrons of plasma after 3-month intervention
Changes in concentrations of triglycerides
Targeted chylomicrons of plasma after 3-month intervention 2
Changes in concentrations of cholesterol
Targeted chylomicrons of plasma after 3-month intervention 3
Changes in concentrations of sphingolipids
Targeted chylomicrons of plasma after 3-month intervention 4
Changes in concentrations of fatty acids
Inflammation markers
Changes in adiponectin
Inflammation markers 2
Changes in CRP
Inflammation markers 3
Changes in cytokines
Inflammation markers 4
Changes in LBP
Inflammation markers 5
Changes in endotoxins
Inflammation markers 6
Changes in CD14
Inflammation markers 7
Gene expressions of inflammation markers after 3-month intervention, measured with dedicated kits and PAXgene kit
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.
Oxidative stress marker
Changes in urinary concentrations of 8-iso-PGF2 alpha isoprostane after 3-month intervention, determined with an ELISA kit
Markers of immune cells
PBMC
Markers of immune cells 2
Complete blood counts
Intestinal microbiota after 3-month intervention.
Changes in microbiome composition and diversity (alpha, beta) of feces (16S analysis)
Intestinal microbiota after 3-month intervention 2
Changes in fecal concentrations of microbiota-derived metabolites (coprostanol, short chain fatty acids (SCFA), calprotectin)
Questionnaires on physical activity
International Physical Activity Questionnaire ([i] ëinactive, [ii] ëminimally active, [iii] ëHEPA activeí (health enhancing physical activity; a high active category).)
Questionnaires on digestive comfort
Liker scale
Questionnaires on digestive comfort
Bristol stool scale
Questionnaires on product satiety
Satiety from visual analog scale (VAS)
Questionnaires food intake
Three-factor eating questionnaire (TFEQ)
Questionnaires on product appreciation
Product appreciation questionnaire
Dietary intake questionnaire
Dietary record questionnaire
Full Information
NCT ID
NCT05783466
First Posted
February 16, 2023
Last Updated
October 4, 2023
Sponsor
Hospices Civils de Lyon
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
1. Study Identification
Unique Protocol Identification Number
NCT05783466
Brief Title
Dairy Lipids and Cardiometabolic Risk
Acronym
DAILICATE
Official Title
Bioactive Dairy Lipids to Manage Cardiometabolic Risk in Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2023 (Actual)
Primary Completion Date
September 2, 2025 (Anticipated)
Study Completion Date
September 2, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Obesity, Nutrition, Dietary intervention, Weight loss, Metabolism, Dairy, Fat, Milk polar lipids
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low-fat dairy products within a dietary handling for weight loss
Arm Type
Other
Arm Description
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.
Arm Title
Whole-fat dairy products within a dietary handling for weight loss
Arm Type
Experimental
Arm Description
3 servings/day of whole-fat dairy products: 1 serving of whole cheese, 1 serving of whole yogurt and 1 serving of whole milk.
Arm Title
Whole-fat dairy products enriched with milk polar lipids within a dietary handling for weight loss
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Low-fat dairy products
Intervention Description
3-month intervention
Intervention Type
Other
Intervention Name(s)
Whole-fat dairy products
Intervention Description
3-month intervention
Intervention Type
Other
Intervention Name(s)
Milk polar lipid enriched whole-fat dairy products
Intervention Description
3-month intervention
Primary Outcome Measure Information:
Title
Total plasma apolipoprotein B concentration
Description
Change in fasting total plasma apolipoprotein B concentration after 3-month intervention, measured by ELISA.
Time Frame
day 0 and day 90
Secondary Outcome Measure Information:
Title
Changes in weight
Description
Changes in weight after 3-month intervention.
Time Frame
day 0 and day 90
Title
Anthropometric measurements 2
Description
Changes in waist and hip circumferences after 3-month intervention.
Time Frame
day 0 and day 90
Title
Body mass composition measurements
Description
Change in body mass composition (lean mass, fat mass) after 3-month intervention, analyzed by impedancemeter
Time Frame
day 0 and day 90
Title
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods
Description
Changes in plasma concentrations of triglycerides
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
Title
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 2
Description
Changes in plasma concentrations of total cholesterol
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.
Title
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 3
Description
Changes in plasma concentrations of LDL-cholesterol
Time Frame
day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: time 360 minutes.
Title
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 4
Description
Changes in plasma concentrations of HDL-cholesterol
Time Frame
day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: time 360 minutes.
Title
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 5
Description
Changes in plasma concentrations of apoB100
Time Frame
day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes -300 minutes.
Title
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 6
Description
Changes in plasma concentrations of apoB48
Time Frame
day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes -300 minutes - 360 minutes
Title
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 7
Description
Changes in plasma concentrations of apoA1
Time Frame
day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements:times 360 minutes.
Title
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 8
Description
Changes in plasma concentrations of unesterified fatty acids
Time Frame
day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes
Title
Glucose concentrations after 3-month intervention, measured using standard laboratory methods
Description
Changes in plasma concentrations of glucose
Time Frame
day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes
Title
Glucose concentrations after 3-month intervention, measured using standard laboratory methods 2
Description
Changes in plasma concentrations of insulin
Time Frame
day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes
Title
Targeted plasma lipidomics after 3-month intervention
Description
Changes in plasma concentrations of phospholipids
Time Frame
day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
Title
Targeted plasma lipidomics after 3-month intervention 2
Description
Changes in plasma concentrations of sphingolipids (sphingomyelins and ceramides)
Time Frame
day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
Title
Targeted plasma lipidomics after 3-month intervention 3
Description
Changes in plasma concentrations of lysophospholipids
Time Frame
day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
Title
Targeted plasma lipidomics after 3-month intervention 4
Description
Changes in plasma concentrations of fatty acids in plasma total lipids
Time Frame
day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
Title
Targeted plasma lipidomics after 3-month intervention 5
Description
Changes in plasma concentrations of phospholipids
Time Frame
day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
Title
Targeted chylomicrons of plasma after 3-month intervention
Description
Changes in concentrations of triglycerides
Time Frame
day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
Title
Targeted chylomicrons of plasma after 3-month intervention 2
Description
Changes in concentrations of cholesterol
Time Frame
day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
Title
Targeted chylomicrons of plasma after 3-month intervention 3
Description
Changes in concentrations of sphingolipids
Time Frame
day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
Title
Targeted chylomicrons of plasma after 3-month intervention 4
Description
Changes in concentrations of fatty acids
Time Frame
day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
Title
Inflammation markers
Description
Changes in adiponectin
Time Frame
day 0 and day 90 for fasting and postprandial measurements.
Title
Inflammation markers 2
Description
Changes in CRP
Time Frame
day 0 and day 90 for fasting and postprandial measurements.
Title
Inflammation markers 3
Description
Changes in cytokines
Time Frame
day 0 and day 90 for fasting and postprandial measurements.
Title
Inflammation markers 4
Description
Changes in LBP
Time Frame
day 0 and day 90 for fasting and postprandial measurements.
Title
Inflammation markers 5
Description
Changes in endotoxins
Time Frame
day 0 and day 90 for fasting and postprandial measurements.
Title
Inflammation markers 6
Description
Changes in CD14
Time Frame
day 0 and day 90 for fasting and postprandial measurements.
Title
Inflammation markers 7
Description
Gene expressions of inflammation markers after 3-month intervention, measured with dedicated kits and PAXgene kit
Time Frame
day 0 and day 90 for fasting and postprandial measurements.
Title
Platelet activation markers
Description
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.
Time Frame
day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements,times 120 minutes-240 minutes-300 minutes -360 minutes.
Title
Oxidative stress marker
Description
Changes in urinary concentrations of 8-iso-PGF2 alpha isoprostane after 3-month intervention, determined with an ELISA kit
Time Frame
day 0 and day 90
Title
Markers of immune cells
Description
PBMC
Time Frame
day 0 and day 90
Title
Markers of immune cells 2
Description
Complete blood counts
Time Frame
day 0 and day 90
Title
Intestinal microbiota after 3-month intervention.
Description
Changes in microbiome composition and diversity (alpha, beta) of feces (16S analysis)
Time Frame
day 0 and day 90
Title
Intestinal microbiota after 3-month intervention 2
Description
Changes in fecal concentrations of microbiota-derived metabolites (coprostanol, short chain fatty acids (SCFA), calprotectin)
Time Frame
day 0 and day 90
Title
Questionnaires on physical activity
Description
International Physical Activity Questionnaire ([i] ëinactive, [ii] ëminimally active, [iii] ëHEPA activeí (health enhancing physical activity; a high active category).)
Time Frame
day 0 and day 90
Title
Questionnaires on digestive comfort
Description
Liker scale
Time Frame
day 0 and day 90
Title
Questionnaires on digestive comfort
Description
Bristol stool scale
Time Frame
day 0 and day 90
Title
Questionnaires on product satiety
Description
Satiety from visual analog scale (VAS)
Time Frame
day 0 and day 90
Title
Questionnaires food intake
Description
Three-factor eating questionnaire (TFEQ)
Time Frame
day 0 and day 90
Title
Questionnaires on product appreciation
Description
Product appreciation questionnaire
Time Frame
day 0 and day 90
Title
Dietary intake questionnaire
Description
Dietary record questionnaire
Time Frame
day 0 and day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women between 18-70 years
Body Mass Index (BMI) between 40 and 55 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuel DISSE, Pr
Phone
+33 4 78 86 14 89
Email
emmanuel.disse@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
MArie-Caroline MICHALSKI, Dr
Phone
+33 4 26 23 61 71
Email
marie-caroline.michalski@inrae.fr
Facility Information:
Facility Name
Centre de Recherche en Nutrition Humaine Rhône-Alpes
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel DISSE, Pr
Phone
+33 4 78 86 14 89
Email
emmanuel.disse@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
SEGRESTIN Bérénice, Dr
First Name & Middle Initial & Last Name & Degree
RAJOT Amélie, Dr
First Name & Middle Initial & Last Name & Degree
CAUSSY Cyrielle, Dr
12. IPD Sharing Statement
Learn more about this trial
Dairy Lipids and Cardiometabolic Risk
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