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

Laboratoires Nutrition et Cardiometabolisme

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: Stablor; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01755104

RCM-EFF-1

Details and patient eligibility

About

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.

Enrollment: 118 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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118 participants in 2 patient groups, including a placebo group

Stablor

Experimental group

Description:

dietary supplement Stablor

Treatment:

Dietary Supplement: Stablor

Placebo

Placebo Comparator group

Description:

dietary supplement Placebo

Treatment:

Dietary Supplement: Placebo