Morbid Obesity
Conditions
Keywords
Obesity, Nutrition, Dietary intervention, Weight loss, Metabolism, Dairy, Fat, Milk polar lipids
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.
Interventions
3-month intervention
OTHERWhole-fat dairy products
3-month intervention
OTHERMilk polar lipid enriched whole-fat dairy products
3-month intervention
Sponsors
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
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Anthropometric measurements 2 | day 0 and day 90 | Changes in waist and hip circumferences 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 | 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 |
| 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 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 |
| 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 7 | day 0 and day 90 for fasting and postprandial measurements. For postprandial measurements:times 360 minutes. | Changes in plasma concentrations of apoA1 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 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 |
| 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 2 | day 0 and day 90 for fasting and postprandial measurements. | Changes in CRP |
| Inflammation markers 3 | day 0 and day 90 for fasting and postprandial measurements. | Changes in cytokines |
| Inflammation markers 4 | day 0 and day 90 for fasting and postprandial measurements. | Changes in LBP |
| 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 |
| 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 | day 0 and day 90 | PBMC |
| 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) |
| 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).) |
| Changes in weight | day 0 and day 90 | Changes in weight after 3-month intervention. |
| Questionnaires on product satiety | day 0 and day 90 | Satiety from visual analog scale (VAS) |
| Questionnaires food intake | day 0 and day 90 | Three-factor eating questionnaire (TFEQ) |
| Questionnaires on product appreciation | day 0 and day 90 | Product appreciation questionnaire |
| Dietary intake questionnaire | day 0 and day 90 | Dietary record questionnaire |
| Questionnaires on digestive comfort | day 0 and day 90 | Liker scale |
Countries
France
Contacts
Primary ContactEmmanuel DISSE, Pr
Backup ContactMArie-Caroline MICHALSKI, Dr
Outcome results
None listed