Clinical trial NCT01755104: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Laboratoires Nutrition et Cardiometabolisme
Sponsor class: INDUSTRY
First posted: 2012-12-24
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in visceral fat area assessed by computerized tomodensitometry
timeFrame: From baseline to Week 12
Secondary outcomes:
measure: Changes in selected cardiometabolic risk factors : anthropometric and physical measurements, biomarkers
timeFrame: from baseline to end of study
measure: Quality of life, psychological and behavioral changes
timeFrame: From baseline to end of study
Other outcomes:
Locations:
city: Laval
country: Canada
facility: Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)
state: Quebec
city: Paris
country: France
facility: Institut CardioMetabolisme et Nutrition (ICAN)
Study officials:
affiliation: Institut CardioMetabolisme et Nutrition (ICAN)
name: Karine Clement, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.