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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A02415-38 | Other Identifier | ID-RCB |
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| Name | Class |
|---|---|
| Laboratoire de Recherche en Cardiovasculaire, Métabolisme, Diabétologie et Nutrition | UNKNOWN |
| Centre de Recherche en Nutrition Humaine Rhone-Alpe | OTHER |
| Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-fat dairy products within a dietary handling for weight loss | Other | 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. |
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| Whole-fat dairy products within a dietary handling for weight loss | Experimental | 3 servings/day of whole-fat dairy products: 1 serving of whole cheese, 1 serving of whole yogurt and 1 serving of whole milk. |
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| Whole-fat dairy products enriched with milk polar lipids within a dietary handling for weight loss | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-fat dairy products | Other | 3-month intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in weight | Changes in weight after 3-month intervention. | day 0 and day 90 |
| Anthropometric measurements 2 | Changes in waist and hip circumferences after 3-month intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emmanuel DISSE, Pr | Contact | +33 4 78 86 14 89 | emmanuel.disse@chu-lyon.fr | |
| MArie-Caroline MICHALSKI, Dr | Contact | +33 4 26 23 61 71 | marie-caroline.michalski@inrae.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherche en Nutrition Humaine Rhône-Alpes | Active, not recruiting | Pierre-Bénite | 69310 | France | ||
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D009765 | Obesity |
| D015431 | Weight Loss |
| C564245 | Platelet Glycoprotein IV Deficiency |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Whole-fat dairy products | Other | 3-month intervention |
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| Milk polar lipid enriched whole-fat dairy products | Other | 3-month intervention |
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| 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 | day 0 and day 90 |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| 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 |
| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Inflammation markers | Changes in adiponectin | day 0 and day 90 for fasting and postprandial measurements. |
| Inflammation markers 2 | Changes in CRP | day 0 and day 90 for fasting and postprandial measurements. |
| Inflammation markers 3 | Changes in cytokines | day 0 and day 90 for fasting and postprandial measurements. |
| Inflammation markers 4 | Changes in LBP | day 0 and day 90 for fasting and postprandial measurements. |
| Inflammation markers 5 | Changes in endotoxins | day 0 and day 90 for fasting and postprandial measurements. |
| Inflammation markers 6 | Changes in CD14 | 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 | 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. | 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 | day 0 and day 90 |
| Markers of immune cells | PBMC | day 0 and day 90 |
| Markers of immune cells 2 | Complete blood counts | day 0 and day 90 |
| Intestinal microbiota after 3-month intervention. | Changes in microbiome composition and diversity (alpha, beta) of feces (16S analysis) | 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) | 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).) | day 0 and day 90 |
| Questionnaires on digestive comfort | Liker scale | day 0 and day 90 |
| Questionnaires on digestive comfort | Bristol stool scale | day 0 and day 90 |
| Questionnaires on product satiety | Satiety from visual analog scale (VAS) | day 0 and day 90 |
| Questionnaires food intake | Three-factor eating questionnaire (TFEQ) | day 0 and day 90 |
| Questionnaires on product appreciation | Product appreciation questionnaire | day 0 and day 90 |
| Dietary intake questionnaire | Dietary record questionnaire | day 0 and day 90 |
| Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition |
| Recruiting |
| Pierre-Bénite |
| 69310 |
| France |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |