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| Name | Class |
|---|---|
| Institute of Cardiometabolism and Nutrition, France | OTHER |
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Clinical intervention on overweight or moderately obeses adults. The objective of this trial is to demonstrate the superior eficacy of Alphagos to placebo on weight loss during a low-calorie diet of 12 weeks. The superiority is judged on body weight. Change in cardiometabolic risk factors through the intervention have been evaluated as secondary endpoints
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alpha-galacto-oliosaccharides | Experimental |
| |
| Placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha-galacto-oligosaccharides | Dietary Supplement | 6g of alpha-galacto-oligosaccharides in a 100 mL flavored drink |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body weight (kg) between day 0 and week 12 | Day 0, Day 7, Month 1, Month 2, Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Feeding behaviour | Changes in feeding behaviour will be studied by :
|
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) | between Day 0 and week 12 | |
| arterial systolic and diastolic pressures | between day 0 and week 12 | |
| Morphological, inflammatory and metabolic characteristics of adipose tissue sampled from the abdominal region |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Investigation Clinique Paris-Est/ Bâtiment Antonin Gosset Hôpital de la Pitié Salpêtrière- 56 Boulevard Vincent Auriol | Paris | 75013 | France |
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| Between day 0 and week 12 |
| Lean body mass | Between day 0 and week 12 |
| Waist circumference | Day 0, day 7, Month1, Month 2, Month 3 |
| Hip circumference | Day 0, Day 7, Month 1, Month 2, Month 3 |
| Waist to hip circumference ratio | Between Day 0 and week 12 |
| Body Fat | Day 7, Month 3 |
Adipocyte size and diameter, secretion profile of subcutaneous adipose tissue, gene expression profile of adipose tissue, lipolytic response and energy metabolism |
| between day 0 and week 12 |
| Components of the intestinal commensal microbiota | between day 0 and week 12 |
| Lipid Profile | Day 0, Week 12 |
| Markers of systemic inflammation | Day 0, Week 12 |
| Glycemic profile | Day 0, Week 12 |
| Circulating adipokines | Day 0, Week 12 |
| Hemostatic factors associated with cardiovascular risks | Day 0, Week 12 |