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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
75
3-month intervention
3-month intervention
3-month intervention
Centre de Recherche en Nutrition Humaine Rhône-Alpes
Pierre-Bénite, France
ACTIVE_NOT_RECRUITINGCentres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition
Pierre-Bénite, France
RECRUITINGTotal plasma apolipoprotein B concentration
Change in fasting total plasma apolipoprotein B concentration after 3-month intervention, measured by ELISA.
Time frame: day 0 and day 90
Changes in weight
Changes in weight after 3-month intervention.
Time frame: day 0 and day 90
Anthropometric measurements 2
Changes in waist and hip circumferences after 3-month intervention.
Time frame: 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
Time frame: day 0 and day 90
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods
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
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 2
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.
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 3
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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.
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 4
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.
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 5
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.
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 6
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
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods 7
Changes in plasma concentrations of apoA1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: day 0 and day 90 for fasting and postprandial measurements.
Inflammation markers 2
Changes in CRP
Time frame: day 0 and day 90 for fasting and postprandial measurements.
Inflammation markers 3
Changes in cytokines
Time frame: day 0 and day 90 for fasting and postprandial measurements.
Inflammation markers 4
Changes in LBP
Time frame: day 0 and day 90 for fasting and postprandial measurements.
Inflammation markers 5
Changes in endotoxins
Time frame: day 0 and day 90 for fasting and postprandial measurements.
Inflammation markers 6
Changes in CD14
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: day 0 and day 90
Markers of immune cells
PBMC
Time frame: day 0 and day 90
Markers of immune cells 2
Complete blood counts
Time frame: day 0 and day 90
Intestinal microbiota after 3-month intervention.
Changes in microbiome composition and diversity (alpha, beta) of feces (16S analysis)
Time frame: 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)
Time frame: 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).)
Time frame: day 0 and day 90
Questionnaires on digestive comfort
Liker scale
Time frame: day 0 and day 90
Questionnaires on digestive comfort
Bristol stool scale
Time frame: day 0 and day 90
Questionnaires on product satiety
Satiety from visual analog scale (VAS)
Time frame: day 0 and day 90
Questionnaires food intake
Three-factor eating questionnaire (TFEQ)
Time frame: day 0 and day 90
Questionnaires on product appreciation
Product appreciation questionnaire
Time frame: day 0 and day 90
Dietary intake questionnaire
Dietary record questionnaire
Time frame: day 0 and day 90