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

This study has been completed.
Sponsor:
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
  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

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:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014