Dairy Lipids and Cardiometabolic Risk
- Conditions
- Morbid Obesity
- Interventions
- Other: Milk polar lipid enriched whole-fat dairy productsOther: Low-fat dairy productsOther: Whole-fat dairy products
- Registration Number
- NCT05783466
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Whole-fat dairy products enriched with milk polar lipids within a dietary handling for weight loss Milk polar lipid enriched whole-fat dairy products 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. Low-fat dairy products within a dietary handling for weight loss Low-fat dairy products 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. Whole-fat dairy products within a dietary handling for weight loss Whole-fat dairy products 3 servings/day of whole-fat dairy products: 1 serving of whole cheese, 1 serving of whole yogurt and 1 serving of whole milk.
- Primary Outcome Measures
Name Time Method Total plasma apolipoprotein B concentration day 0 and day 90 Change in fasting total plasma apolipoprotein B concentration after 3-month intervention, measured by ELISA.
- Secondary Outcome Measures
Name Time Method Anthropometric measurements 2 day 0 and day 90 Changes in waist and hip circumferences after 3-month intervention.
Changes in weight day 0 and day 90 Changes in weight after 3-month intervention.
Body mass composition measurements day 0 and day 90 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 3 day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: time 360 minutes. Changes in plasma concentrations of LDL-cholesterol
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 4 day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: time 360 minutes. Changes in plasma concentrations of HDL-cholesterol
Glucose concentrations after 3-month intervention, measured using standard laboratory methods day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes Changes in plasma concentrations of glucose
Glucose concentrations after 3-month intervention, measured using standard laboratory methods 2 day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements: times 120 minutes -240 minutes Changes in plasma concentrations of insulin
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 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
Targeted plasma lipidomics after 3-month intervention 4 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
Targeted chylomicrons of plasma after 3-month intervention 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
Targeted chylomicrons of plasma after 3-month intervention 2 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
Targeted chylomicrons of plasma after 3-month intervention 3 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
Targeted chylomicrons of plasma after 3-month intervention 4 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
Inflammation markers day 0 and day 90 for fasting and postprandial measurements. Changes in adiponectin
Inflammation markers 5 day 0 and day 90 for fasting and postprandial measurements. Changes in endotoxins
Inflammation markers 6 day 0 and day 90 for fasting and postprandial measurements. Changes in CD14
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 7 day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements:times 360 minutes. Changes in plasma concentrations of apoA1
Inflammation markers 4 day 0 and day 90 for fasting and postprandial measurements. Changes in LBP
Inflammation markers 7 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
Platelet activation markers 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.Oxidative stress marker day 0 and day 90 Changes in urinary concentrations of 8-iso-PGF2 alpha isoprostane after 3-month intervention, determined with an ELISA kit
Markers of immune cells 2 day 0 and day 90 Complete blood counts
Intestinal microbiota after 3-month intervention. day 0 and day 90 Changes in microbiome composition and diversity (alpha, beta) of feces (16S analysis)
Intestinal microbiota after 3-month intervention 2 day 0 and day 90 Changes in fecal concentrations of microbiota-derived metabolites (coprostanol, short chain fatty acids (SCFA), calprotectin)
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 2 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
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 5 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
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 6 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
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 8 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
Targeted plasma lipidomics after 3-month intervention 2 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)
Targeted plasma lipidomics after 3-month intervention 3 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
Inflammation markers 3 day 0 and day 90 for fasting and postprandial measurements. Changes in cytokines
Markers of immune cells day 0 and day 90 PBMC
Questionnaires on digestive comfort day 0 and day 90 Bristol stool scale
Targeted plasma lipidomics after 3-month intervention 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
Questionnaires on physical activity 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).)
Questionnaires on product satiety day 0 and day 90 Satiety from visual analog scale (VAS)
Targeted plasma lipidomics after 3-month intervention 5 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
Inflammation markers 2 day 0 and day 90 for fasting and postprandial measurements. Changes in CRP
Questionnaires on product appreciation day 0 and day 90 Product appreciation questionnaire
Questionnaires food intake day 0 and day 90 Three-factor eating questionnaire (TFEQ)
Dietary intake questionnaire day 0 and day 90 Dietary record questionnaire
Trial Locations
- Locations (2)
Centre de Recherche en Nutrition Humaine Rhône-Alpes
🇫🇷Pierre-Bénite, France
Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition
🇫🇷Pierre-Bénite, France