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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

Tracking Information
First Submitted Date  ICMJE December 18, 2012
First Posted Date  ICMJE December 24, 2012
Last Update Posted Date March 7, 2014
Study Start Date  ICMJE January 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
Change in visceral fat area assessed by computerized tomodensitometry [ Time Frame: From baseline to Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2012)
  • Changes in selected cardiometabolic risk factors : anthropometric and physical measurements, biomarkers [ Time Frame: from baseline to end of study ]
  • Quality of life, psychological and behavioral changes [ Time Frame: From baseline to end of study ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Stablor on Visceral Fat Loss in Patients With a Metabolic Syndrome
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE
  • Dietary Supplement: Stablor
  • Dietary Supplement: Placebo
Study Arms  ICMJE
  • Experimental: Stablor
    dietary supplement Stablor
    Intervention: Dietary Supplement: Stablor
  • Placebo Comparator: Placebo
    dietary supplement Placebo
    Intervention: Dietary Supplement: Placebo
Publications * Bel Lassen P, Belda E, Prifti E, Dao MC, Specque F, Henegar C, Rinaldi L, Wang X, Kennedy SP, Zucker JD, Calame W, Lamarche B, Claus SP, Clément K. Protein supplementation during an energy-restricted diet induces visceral fat loss and gut microbiota amino acid metabolism activation: a randomized trial. Sci Rep. 2021 Aug 2;11(1):15620. doi: 10.1038/s41598-021-94916-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2013)
118
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2012)
120
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01755104
Other Study ID Numbers  ICMJE RCM-EFF-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Laboratoires Nutrition et Cardiometabolisme
Study Sponsor  ICMJE Laboratoires Nutrition et Cardiometabolisme
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karine Clement, MD Institut CardioMetabolisme et Nutrition (ICAN)
PRS Account Laboratoires Nutrition et Cardiometabolisme
Verification Date March 2014

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