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

NCT01755104 | Completed

• 1 other identifier: RCM-EFF-1
• Study Type: interventional
• Target: 118
• Locations: 2 countries
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Change in visceral fat area assessed by computerized tomodensitometry

  From baseline to Week 12

Secondary Outcomes (2)

• Changes in selected cardiometabolic risk factors : anthropometric and physical measurements, biomarkers

  from baseline to end of study

• Quality of life, psychological and behavioral changes

  From baseline to end of study

Study Arms (2)

Stablor

EXPERIMENTAL

dietary supplement Stablor

Dietary Supplement: Stablor

Placebo

PLACEBO COMPARATOR

dietary supplement Placebo

Dietary Supplement: Placebo

Interventions

Stablor DIETARY_SUPPLEMENT

Stablor

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratoires Nutrition et Cardiometabolisme: lead

Study Sites (2)

Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)

Laval, Quebec, Canada

Location

Institut CardioMetabolisme et Nutrition (ICAN)

Paris, France

Location

Related Publications (1)

• 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.

  PMID: 34341379 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Karine Clement, MD

  Institut CardioMetabolisme et Nutrition (ICAN)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 24, 2012
• Study Start: January 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 7, 2014

Record last verified: 2014-03

Locations

CA (1); FR (1)