Dairy Lipids and Cardiometabolic Risk

Morbid Obesity Clinical Trial

— DAILICATE  

Official title:

Bioactive Dairy Lipids to Manage Cardiometabolic Risk in Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05783466
• Other study ID #: 69HCL22_0461
• Secondary ID: 2022-A02415-38
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2023
• Est. completion date: September 2, 2025

Study information

• Verified date: October 2023
• Source: Hospices Civils de Lyon
• Contact: Emmanuel DISSE, Pr
• Phone: +33 4 78 86 14 89
• Email: emmanuel.disse[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: September 2, 2025
• Est. primary completion date: September 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

Other:
• Low-fat dairy products
3-month intervention
• Whole-fat dairy products
3-month intervention
• Milk polar lipid enriched whole-fat dairy products
3-month intervention

Locations

Country	Name	City	State
France	Centre de Recherche en Nutrition Humaine Rhône-Alpes	Pierre-Bénite
France	Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition	Pierre-Bénite

Sponsors (4)

Lead Sponsor	Collaborator
Hospices Civils de Lyon	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

Country where clinical trial is conducted

France, 

Outcome

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