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

NCT ID: NCT01755104

Last Updated: 2014-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-02-28

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Stablor

dietary supplement Stablor

Group Type: EXPERIMENTAL

Stablor

Intervention Type: DIETARY_SUPPLEMENT

Placebo

dietary supplement Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Stablor

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratoires Nutrition et Cardiometabolisme

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karine Clement, MD

Role: PRINCIPAL_INVESTIGATOR

Institut CardioMetabolisme et Nutrition (ICAN)

Locations

Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)

Laval, Quebec, Canada

Institut CardioMetabolisme et Nutrition (ICAN)

Paris, , France

Countries

Canada; France

References

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.

Reference Type: DERIVED

PMID: 34341379 (View on PubMed)

Other Identifiers

RCM-EFF-1

Identifier Type: -

Identifier Source: org_study_id