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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

December 18, 2012
March 6, 2014
January 2013
February 2014   (final data collection date for primary outcome measure)
Change in visceral fat area assessed by computerized tomodensitometry [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01755104 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Effect of Stablor on Visceral Fat Loss in Patients With a Metabolic Syndrome
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Metabolic Syndrome
  • Dietary Supplement: Stablor
  • Dietary Supplement: Placebo
  • Experimental: Stablor
    dietary supplement Stablor
    Intervention: Dietary Supplement: Stablor
  • Placebo Comparator: Placebo
    dietary supplement Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
February 2014
February 2014   (final data collection date for primary outcome measure)

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

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France
 
NCT01755104
RCM-EFF-1
No
Laboratoires Nutrition et Cardiometabolisme
Laboratoires Nutrition et Cardiometabolisme
Not Provided
Principal Investigator: Karine Clement, MD Institut CardioMetabolisme et Nutrition (ICAN)
Laboratoires Nutrition et Cardiometabolisme
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP