Effect of Stablor on Visceral Fat Loss in Patients With a Metabolic Syndrome

This study has been completed.
Information provided by (Responsible Party):
Laboratoires Nutrition et Cardiometabolisme
ClinicalTrials.gov Identifier:
First received: December 18, 2012
Last updated: March 6, 2014
Last verified: March 2014
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


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01755104

Canada, Quebec
Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)
Laval, Quebec, Canada
Institut CardioMetabolisme et Nutrition (ICAN)
Paris, France
Sponsors and Collaborators
Laboratoires Nutrition et Cardiometabolisme
Principal Investigator: Karine Clement, MD Institut CardioMetabolisme et Nutrition (ICAN)
  More Information

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
Insulin Resistance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 26, 2016