A randomized, double-blind, placebo-controlled, multi-center, parallel group study on overweight and obese individuals following healthy lifestyle consisting of calorie-reduced diet (20% calorie restriction) and increase in daily activity (1000 steps more per day once compared to the baseline steps)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
418
Daily intake of Bifidobacterium animalis ssp. lactis 420 or placebo for a 6-month period
CEN nutriment
Dijon, France
Eurofins Optimed
Gières, France
Biofortis SAS
Saint-Herblain, France
Cap Vallcarca
Barcelona, Spain
Total body fat mass relative change
Difference in total body fat mass relative change from baseline (Visit 2) to 6 months of product intake (Visit 5) between the active vs. placebo group
Time frame: Change from baseline at 6 months
Trunk fat mass change
Change in trunk fat mass from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative)
Time frame: Change from baseline at 2 months, 4 months and 6 months
Waist circumference change
Change in waist circumference from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative)
Time frame: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)
Android fat mass change
Change in android fat mass from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative)
Time frame: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)
Lean body mass change
Change in lean body mass from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative)
Time frame: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)
Energy intake change
Change in energy intake from baseline (Visit 2) to 6 months (Visit 5)
Time frame: Change from baseline at 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CAP Centelles
Barcelona, Spain
CAP Hostalets
Barcelona, Spain
CAP Muralles
Tarragona, Spain
Fat mass change in individual body regions
Change in fat mass in other individual body regions from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative)
Time frame: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)
Total fat mass absolute change
Change in total body fat mass absolute change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)
Time frame: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)
Body weight change
Change in body weight from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative)
Time frame: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)
BMI change
Change in BMI from baseline (Visit 2) to 6 months (Visit 5) (absolute and relative)
Time frame: Change from baseline at 6 months
Hip circumference change
Change in hip circumference from baseline (Visit 2) to, 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative)
Time frame: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)
Total fat mass relative change
Change in total body fat mass relative change from baseline (Visit 2) to 2 months (Visit 3), and 4 months (Visit 4)
Time frame: Change from baseline (Visit 2) to 2 months (Visit 3), and 4 months (Visit 4)