Effect of Stablor on Visceral Fat Loss in Patients With a Metabolic Syndrome
This study has been completed.
Sponsor:
Laboratoires Nutrition et Cardiometabolisme
Information provided by (Responsible Party):
Laboratoires Nutrition et Cardiometabolisme
ClinicalTrials.gov Identifier:
NCT01755104
First received: December 18, 2012
Last updated: March 6, 2014
Last verified: March 2014
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Purpose
The purpose of the study is to evaluate the impact of the intake of a dietary supplement STABLOR™ on the change of the abdominal visceral fat mass in patients with a metabolic syndrome.
| Condition | Intervention |
|---|---|
|
Metabolic Syndrome |
Dietary Supplement: Stablor Dietary Supplement: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized Double-blind Placebo Controlled Trial on the Effect of Stablor™ on the Abdominal Visceral Fat Mass Loss in Patients With a Metabolic Syndrome |
Resource links provided by NLM:
Further study details as provided by Laboratoires Nutrition et Cardiometabolisme:
Primary Outcome Measures:
- Change in visceral fat area assessed by computerized tomodensitometry [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in selected cardiometabolic risk factors : anthropometric and physical measurements, biomarkers [ Time Frame: from baseline to end of study ] [ Designated as safety issue: No ]
- Quality of life, psychological and behavioral changes [ Time Frame: From baseline to end of study ] [ Designated as safety issue: No ]
| Enrollment: | 118 |
| Study Start Date: | January 2013 |
| Study Completion Date: | February 2014 |
| Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Stablor
dietary supplement Stablor
|
Dietary Supplement: Stablor |
|
Placebo Comparator: Placebo
dietary supplement Placebo
|
Dietary Supplement: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 :
- Arterial Blood pressure > or = 130 mmHg (systolic) and/or more than or equal to 85 mmHg (diastolic) or stabilized with treatment for at least 6 months,
- Fasting glycemia > or = 1 g/L or 5.6 mmol/L or stabilized with treatment for at least 6 months and non-diabetic < 1.26 g/L,
- Triglycerides > or = 1.5 g/L or 1.71 mmol/L or stabilized with treatment for at least 6 months,
- HDL Cholesterol <0.40 g/L or 1.03 mmol/L (males) and <0,5 g/l or 1.29 mmol/L (females) or stabilized with treatment for at least 6 months.
Exclusion Criteria:
- Pregnant (positive pregnancy test at the selection visit or breast-feeding woman,
- Woman of childbearing potential without an efficient contraception method,
The above information is not intended to contain all considerations relevant to a patient's potential participation in the clinical trial
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01755104
Please refer to this study by its ClinicalTrials.gov identifier: NCT01755104
Locations
| Canada, Quebec | |
| Institut des Nutraceutiques et des Aliments Fonctionnels (INAF) | |
| Laval, Quebec, Canada | |
| France | |
| Institut CardioMetabolisme et Nutrition (ICAN) | |
| Paris, France | |
Sponsors and Collaborators
Laboratoires Nutrition et Cardiometabolisme
Investigators
| Principal Investigator: | Karine Clement, MD | Institut CardioMetabolisme et Nutrition (ICAN) |
More Information
No publications provided
| Responsible Party: | Laboratoires Nutrition et Cardiometabolisme |
| ClinicalTrials.gov Identifier: | NCT01755104 History of Changes |
| Other Study ID Numbers: | RCM-EFF-1 |
| Study First Received: | December 18, 2012 |
| Last Updated: | March 6, 2014 |
| Health Authority: | France: Agence Nationale de Sécurité du Médicament et des produits de santé Canada: Health Canada |
Additional relevant MeSH terms:
|
Metabolic Syndrome X Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases |
ClinicalTrials.gov processed this record on March 03, 2015