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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Stablor
Placebo
Sponsored by
Laboratoires Nutrition et Cardiometabolisme
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)
  • Institut CardioMetabolisme et Nutrition (ICAN)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Stablor

Placebo

Arm Description

dietary supplement Stablor

dietary supplement Placebo

Outcomes

Primary Outcome Measures

Change in visceral fat area assessed by computerized tomodensitometry

Secondary Outcome Measures

Changes in selected cardiometabolic risk factors : anthropometric and physical measurements, biomarkers
Quality of life, psychological and behavioral changes

Full Information

First Posted
December 18, 2012
Last Updated
March 6, 2014
Sponsor
Laboratoires Nutrition et Cardiometabolisme
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1. Study Identification

Unique Protocol Identification Number
NCT01755104
Brief Title
Effect of Stablor on Visceral Fat Loss in Patients With a Metabolic Syndrome
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 Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Nutrition et Cardiometabolisme

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stablor
Arm Type
Experimental
Arm Description
dietary supplement Stablor
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
dietary supplement Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Stablor
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in visceral fat area assessed by computerized tomodensitometry
Time Frame
From baseline to Week 12
Secondary Outcome Measure Information:
Title
Changes in selected cardiometabolic risk factors : anthropometric and physical measurements, biomarkers
Time Frame
from baseline to end of study
Title
Quality of life, psychological and behavioral changes
Time Frame
From baseline to end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karine Clement, MD
Organizational Affiliation
Institut CardioMetabolisme et Nutrition (ICAN)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
Institut CardioMetabolisme et Nutrition (ICAN)
City
Paris
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34341379
Citation
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, Clement 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.
Results Reference
derived

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

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