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

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Stablor

• Registration Number: NCT01755104
• Lead Sponsor: Laboratoires Nutrition et Cardiometabolisme

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2012-12-18
• Study First Posted: 2012-12-24
• Study Start: 2013-01
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-06
• Last Update Posted: 2014-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	dietary supplement Placebo
Stablor	Stablor	dietary supplement Stablor

Primary Outcome Measures

Name	Time	Method
Change in visceral fat area assessed by computerized tomodensitometry	From baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Quality of life, psychological and behavioral changes	From baseline to end of study
Changes in selected cardiometabolic risk factors : anthropometric and physical measurements, biomarkers	from baseline to end of study

Trial Locations

Locations (2)

Institut CardioMetabolisme et Nutrition (ICAN); 🇫🇷 Paris, France

Institut des Nutraceutiques et des Aliments Fonctionnels (INAF); 🇨🇦 Laval, Quebec, Canada