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OpenTrials
Completed

NCT Number: NCT01755104

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

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stablor

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Change in visceral fat area assessed by computerized tomodensitometry

    Time frame: From baseline to Week 12

Secondary outcomes

  1. Changes in selected cardiometabolic risk factors : anthropometric and physical measurements, biomarkers

    Time frame: from baseline to end of study

  2. Quality of life, psychological and behavioral changes

    Time frame: From baseline to end of study

Sponsors and collaborators

Lead sponsor

Laboratoires Nutrition et Cardiometabolisme

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 24, 2012
Registry last updated
Mar 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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