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

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ClinicalTrials.gov Identifier: NCT01755104
Recruitment Status : Completed
First Posted : December 24, 2012
Last Update Posted : March 7, 2014
Sponsor:
Information provided by (Responsible Party):
Laboratoires Nutrition et Cardiometabolisme

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: Stablor Dietary Supplement: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Stablor
dietary supplement Stablor
 Dietary Supplement: Stablor
Placebo Comparator: Placebo
dietary supplement Placebo
 Dietary Supplement: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change in visceral fat area assessed by computerized tomodensitometry [ Time Frame: From baseline to Week 12 ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Laboratoires Nutrition et Cardiometabolisme
ClinicalTrials.gov Identifier: NCT01755104     History of Changes
Other Study ID Numbers: RCM-EFF-1
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: March 7, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
 Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases