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The purpose of the study is to evaluate the impact of the intake of a dietary supplement STABLORâ„¢ on the change of the abdominal visceral fat mass in patients with a metabolic syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stablor | Experimental | dietary supplement Stablor |
|
| Placebo | Placebo Comparator | dietary supplement Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stablor | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in visceral fat area assessed by computerized tomodensitometry | From baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in selected cardiometabolic risk factors : anthropometric and physical measurements, biomarkers | from baseline to end of study | |
| Quality of life, psychological and behavioral changes | From baseline to end of study |
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Inclusion Criteria:
With a Body Mass Index (BMI) more than or equal to 25 kg/m² and less than 40 kg/m²,
With a metabolic syndrome characterized by a a waist circumference of more than 94 cm for the males (90 cm for South-Asians, Chinese and Japanese) and more than 80 cm for the females, and at least 2 of the following criteria :
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in the clinical trial
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| Name | Affiliation | Role |
|---|---|---|
| Karine Clement, MD | Institut CardioMetabolisme et Nutrition (ICAN) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut des Nutraceutiques et des Aliments Fonctionnels (INAF) | Laval | Quebec | Canada | |||
| Institut CardioMetabolisme et Nutrition (ICAN) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34341379 | Derived | Bel Lassen P, Belda E, Prifti E, Dao MC, Specque F, Henegar C, Rinaldi L, Wang X, Kennedy SP, Zucker JD, Calame W, Lamarche B, Claus SP, Clement K. Protein supplementation during an energy-restricted diet induces visceral fat loss and gut microbiota amino acid metabolism activation: a randomized trial. Sci Rep. 2021 Aug 2;11(1):15620. doi: 10.1038/s41598-021-94916-9. |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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|
| Paris |
| France |
| D009750 |
| Nutritional and Metabolic Diseases |