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| Name | Class |
|---|---|
| Biofortis Mérieux NutriSciences | OTHER |
| StatistiCal BV Wassenarr, The Netherland represented by Dr W.Calame | UNKNOWN |
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The primary objective of the study is to assess the efficacy of STABLOR® consumption on visceral fat mass compared to placebo, in persons with metabolic syndrome during 12 weeks of consumption.
It is expected that the food product STABLOR will reduce visceral fat mass in subjects with metabolic syndrome and therefore will improve cardiometabolic risk factors. The aim of the current study is to assess the impact of a 12-week intake of STABLOR, compared to a placebo, on visceral fat in patients with metabolic syndrome. The primary objective of the study is to assess the efficacy of 12-week STABLOR® consumption on visceral fat mass compared to placebo, in persons with metabolic syndrome. The Secondary outcomes include Anthropometric measurements and body composition, metabolic syndrome status, STABLOR® metabolism, Cardiovascular biomarkers, Systemic inflammation, Quality of life and Behavior.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stablor | Experimental | 2 sachets to be taken twice a day at breakfast and in the afternoon as a snack during 12 weeks |
|
| placebo | Placebo Comparator | 2 sachets to be taken twice a day at breakfast and in the afternoon as a snack during 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stablor | Dietary Supplement | Stablor sachet |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change of visceral fat mass (in cubic millimeter) assessed by Magnetic Resonance Imaging | between week 0, week 9, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of visceral fat mass in percentage assessed by Magnetic Resonance Imaging | between Week 0, Week 9 and Week 12 | |
| Changes of total abdominal fat mass in cubic millimeter assessed by Magnetic Resonance Imaging | between Week 0, Week 9 and Week 12 |
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Inclusion Criteria:
Female or male
Age between 18 and 65 years (limits included),
BMI between 27 and 40 kg/m² (limits included),
With metabolic syndrome: Waist circumference > 94 cm for male (>90 cm for male of South-East Asian, Chinese and Japanese ethnic groups) and > 80 cm for female and at least two of the following criteria :
Good general and mental health with in the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination,
Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form,
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie Déciron, MD | BioFortis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEN Experimental | Dijon | 21000 | France | |||
| Eurofins Optimed |
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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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| Dietary Supplement |
placebo sachet |
|
| Changes of subcutaneous fat mass in cubic millimeter assessed by Magnetic Resonance Imaging | between Week 0, Week 9 and Week 12 |
| Changes of total abdominal fat mass in percentage assessed by Magnetic Resonance Imaging | between Week 0, Week 9 and Week 12 |
| Changes of subcutaneous fat mass in percentage assessed by Magnetic Resonance Imaging | between Week 0, Week 9 and Week 12 |
| Changes of body fat mass measured by Dual-energy X-ray absorptiometry | between Week 0 and Week 12 |
| Changes of body lean mass measured by Dual-energy X-ray absorptiometry | between Week 0 and Week 12 |
| Changes of trunk fat assessed by Dual-energy X-ray absorptiometry | calculated trunk fat | between Week 0 and Week 12 |
| Changes of anthropometrics measurements : weight | Weight | between Week 0 and Week 12 |
| Changes of anthropometrics measurements : BMI | BMI | between Week 0 and Week 12 |
| Changes of anthropometrics measurements: Waist circumference | Waist Circumference | between Week 0 and Week 12 |
| Changes of anthropometrics measurements: Hip Circumference | Hip Circumference | between Week 0 and Week 12 |
| Changes of anthropometrics measurements: Waist to Hip ratio | Waist to Hip ratio | between Week 0 and Week 12 |
| Changes of anthropometrics measurements: Waist to Height ratio | Waist to Height ratio | between Week 0 and Week 12 |
| Gières |
| 38610 |
| France |
| Institut Pasteur de Lille | Lille | 59019 | France |
| CIC Pitié Salpêtrière | Paris | 75651 | France |
| Biofortis | Saint-Herblain | 44800 | France |
| Atlantia Food Clinical Trials | Cork | Ireland |
| D009750 |
| Nutritional and Metabolic Diseases |