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

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755104
• Other study ID #: RCM-EFF-1
• Status: Completed
• Phase: N/A
• First received: December 18, 2012
• Last updated: March 6, 2014
• Start date: January 2013
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Laboratoires Nutrition et Cardiometabolisme
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Stablor

• Placebo

Locations

Country	Name	City	State
Canada	Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)	Laval	Quebec
France	Institut CardioMetabolisme et Nutrition (ICAN)	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Nutrition et Cardiometabolisme

Countries where clinical trial is conducted

Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in visceral fat area assessed by computerized tomodensitometry		From baseline to Week 12	No
Secondary	Changes in selected cardiometabolic risk factors : anthropometric and physical measurements, biomarkers		from baseline to end of study	No
Secondary	Quality of life, psychological and behavioral changes		From baseline to end of study	No