The primary objective of the study is to assess the efficacy of STABLOR® consumption on visceral fat mass compared to placebo, in persons with metabolic syndrome during 12 weeks of consumption.
It is expected that the food product STABLOR will reduce visceral fat mass in subjects with metabolic syndrome and therefore will improve cardiometabolic risk factors. The aim of the current study is to assess the impact of a 12-week intake of STABLOR, compared to a placebo, on visceral fat in patients with metabolic syndrome. The primary objective of the study is to assess the efficacy of 12-week STABLOR® consumption on visceral fat mass compared to placebo, in persons with metabolic syndrome. The Secondary outcomes include Anthropometric measurements and body composition, metabolic syndrome status, STABLOR® metabolism, Cardiovascular biomarkers, Systemic inflammation, Quality of life and Behavior.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
CEN Experimental
Dijon, France
Eurofins Optimed
Gières, France
Institut Pasteur de Lille
Lille, France
CIC Pitié Salpêtrière
Paris, France
Biofortis
Absolute change of visceral fat mass (in cubic millimeter) assessed by Magnetic Resonance Imaging
Time frame: between week 0, week 9, week 12
Change of visceral fat mass in percentage assessed by Magnetic Resonance Imaging
Time frame: between Week 0, Week 9 and Week 12
Changes of total abdominal fat mass in cubic millimeter assessed by Magnetic Resonance Imaging
Time frame: between Week 0, Week 9 and Week 12
Changes of subcutaneous fat mass in cubic millimeter assessed by Magnetic Resonance Imaging
Time frame: between Week 0, Week 9 and Week 12
Changes of total abdominal fat mass in percentage assessed by Magnetic Resonance Imaging
Time frame: between Week 0, Week 9 and Week 12
Changes of subcutaneous fat mass in percentage assessed by Magnetic Resonance Imaging
Time frame: between Week 0, Week 9 and Week 12
Changes of body fat mass measured by Dual-energy X-ray absorptiometry
Time frame: between Week 0 and Week 12
Changes of body lean mass measured by Dual-energy X-ray absorptiometry
Time frame: between Week 0 and Week 12
Changes of trunk fat assessed by Dual-energy X-ray absorptiometry
calculated trunk fat
Time frame: between Week 0 and Week 12
Changes of anthropometrics measurements : weight
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Saint-Herblain, France
Atlantia Food Clinical Trials
Cork, Ireland
Weight
Time frame: between Week 0 and Week 12
Changes of anthropometrics measurements : BMI
BMI
Time frame: between Week 0 and Week 12
Changes of anthropometrics measurements: Waist circumference
Waist Circumference
Time frame: between Week 0 and Week 12
Changes of anthropometrics measurements: Hip Circumference
Hip Circumference
Time frame: between Week 0 and Week 12
Changes of anthropometrics measurements: Waist to Hip ratio
Waist to Hip ratio
Time frame: between Week 0 and Week 12
Changes of anthropometrics measurements: Waist to Height ratio
Waist to Height ratio
Time frame: between Week 0 and Week 12