Effect of Stablor on Visceral Fat Loss in Patients With a Metabolic Syndrome
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ClinicalTrials.gov Identifier: NCT01755104 |
Recruitment Status
:
Completed
First Posted
: December 24, 2012
Last Update Posted
: March 7, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metabolic Syndrome | Dietary Supplement: Stablor Dietary Supplement: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 118 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, 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 |
Study Start Date : | January 2013 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | February 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Stablor
dietary supplement Stablor
|
Dietary Supplement: Stablor |
Placebo Comparator: Placebo
dietary supplement Placebo
|
Dietary Supplement: Placebo |
- Change in visceral fat area assessed by computerized tomodensitometry [ Time Frame: From baseline to Week 12 ]
- Changes in selected cardiometabolic risk factors : anthropometric and physical measurements, biomarkers [ Time Frame: from baseline to end of study ]
- Quality of life, psychological and behavioral changes [ Time Frame: From baseline to end of study ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755104
Canada, Quebec | |
Institut des Nutraceutiques et des Aliments Fonctionnels (INAF) | |
Laval, Quebec, Canada | |
France | |
Institut CardioMetabolisme et Nutrition (ICAN) | |
Paris, France |
Principal Investigator: | Karine Clement, MD | Institut CardioMetabolisme et Nutrition (ICAN) |
Responsible Party: | Laboratoires Nutrition et Cardiometabolisme |
ClinicalTrials.gov Identifier: | NCT01755104 History of Changes |
Other Study ID Numbers: |
RCM-EFF-1 |
First Posted: | December 24, 2012 Key Record Dates |
Last Update Posted: | March 7, 2014 |
Last Verified: | March 2014 |
Additional relevant MeSH terms:
Syndrome Metabolic Syndrome X Disease Pathologic Processes |
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |