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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01755104

Enrollment

118

Registered

2012-12-24

Start date

2013-01-31

Completion date

2014-02-28

Last updated

2014-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DIETARY_SUPPLEMENTStablor

DIETARY_SUPPLEMENTPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Change in visceral fat area assessed by computerized tomodensitometry	From baseline to Week 12

Secondary

Measure	Time frame
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

Countries

Canada, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026