Clinical trial NCT05783466: Dairy Lipids and Cardiometabolic Risk
Official title: Bioactive Dairy Lipids to Manage Cardiometabolic Risk in Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Morbid Obesity
Keywords: Obesity
Nutrition
Dietary intervention
Weight loss
Metabolism
Dairy
Fat
Milk polar lipids
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: Laboratoire de Recherche en Cardiovasculaire, Métabolisme, Diabétologie et Nutrition
name: Centre de Recherche en Nutrition Humaine Rhone-Alpe
name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
First posted: 2023-03-24
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total plasma apolipoprotein B concentration
timeFrame: day 0 and day 90
Secondary outcomes:
measure: Changes in weight
timeFrame: day 0 and day 90
measure: Anthropometric measurements 2
timeFrame: day 0 and day 90
measure: Body mass composition measurements
timeFrame: day 0 and day 90
measure: Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods
timeFrame: 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
measure: Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 2
timeFrame: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -180 minutes -240 minutes -270 minutes -300 minutes.
measure: Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 3
timeFrame: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: time 360 minutes.
measure: Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 4
timeFrame: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: time 360 minutes.
measure: Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 5
timeFrame: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes -300 minutes.
measure: Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 6
timeFrame: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes -300 minutes - 360 minutes
measure: Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 7
timeFrame: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements:times 360 minutes.
measure: Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 8
timeFrame: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes
measure: Glucose concentrations after 3-month intervention, measured using standard laboratory methods
timeFrame: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes
measure: Glucose concentrations after 3-month intervention, measured using standard laboratory methods 2
timeFrame: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes
measure: Targeted plasma lipidomics after 3-month intervention
timeFrame: day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
measure: Targeted plasma lipidomics after 3-month intervention 2
timeFrame: day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
measure: Targeted plasma lipidomics after 3-month intervention 3
timeFrame: day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
measure: Targeted plasma lipidomics after 3-month intervention 4
timeFrame: day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
measure: Targeted plasma lipidomics after 3-month intervention 5
timeFrame: day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
measure: Targeted chylomicrons of plasma after 3-month intervention
timeFrame: day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
measure: Targeted chylomicrons of plasma after 3-month intervention 2
timeFrame: day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
measure: Targeted chylomicrons of plasma after 3-month intervention 3
timeFrame: day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
measure: Targeted chylomicrons of plasma after 3-month intervention 4
timeFrame: day 0 and day 90 for fasting and postprandial measurements For postprandial measurements :times 120 minutes -240 minutes -300 minutes -360 minutes.
measure: Inflammation markers
timeFrame: day 0 and day 90 for fasting and postprandial measurements.
measure: Inflammation markers 2
timeFrame: day 0 and day 90 for fasting and postprandial measurements.
measure: Inflammation markers 3
timeFrame: day 0 and day 90 for fasting and postprandial measurements.
measure: Inflammation markers 4
timeFrame: day 0 and day 90 for fasting and postprandial measurements.
measure: Inflammation markers 5
timeFrame: day 0 and day 90 for fasting and postprandial measurements.
measure: Inflammation markers 6
timeFrame: day 0 and day 90 for fasting and postprandial measurements.
measure: Inflammation markers 7
timeFrame: day 0 and day 90 for fasting and postprandial measurements.
measure: Platelet activation markers
timeFrame: day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements,times 120 minutes-240 minutes-300 minutes -360 minutes.
measure: Oxidative stress marker
timeFrame: day 0 and day 90
measure: Markers of immune cells
timeFrame: day 0 and day 90
measure: Markers of immune cells 2
timeFrame: day 0 and day 90
measure: Intestinal microbiota after 3-month intervention.
timeFrame: day 0 and day 90
measure: Intestinal microbiota after 3-month intervention 2
timeFrame: day 0 and day 90
measure: Questionnaires on physical activity
timeFrame: day 0 and day 90
measure: Questionnaires on digestive comfort
timeFrame: day 0 and day 90
measure: Questionnaires on digestive comfort
timeFrame: day 0 and day 90
measure: Questionnaires on product satiety
timeFrame: day 0 and day 90
measure: Questionnaires food intake
timeFrame: day 0 and day 90
measure: Questionnaires on product appreciation
timeFrame: day 0 and day 90
measure: Dietary intake questionnaire
timeFrame: day 0 and day 90
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre de Recherche en Nutrition Humaine Rhône-Alpes
city: Pierre-Bénite
country: France
facility: Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition
Study officials:
References: