Probiotic with or without fiber controls body fat mass, associated with serum zonulin, in overweight and obese adults—randomized controlled trial.¹

Study aim 

To investigate the effects of Bifidobacterium animalis ssp. lactis B420™ and the dietary fiber Litesse® Ultra™ polydextrose (LU) on body fat mass and other obesity-related parameters.

Study design

Double-blind, randomized, placebo-controlled, multi-center clinical trial

Study method

• 225 healthy volunteers (healthy, BMI 28–34.9) were randomized to four groups for 6 months of double-blind, parallel treatment: 
  • Placebo (microcrystalline cellulose, 12 g/day)
  • LU (12 g/day)
  • B420™ (10 billion CFU/day) in microcrystalline cellulose (12 g/day) 
  • LU (12 g/day) and B420™ (10 billion CFU/day). 
• Body composition was monitored with dual-energy X-ray absorptiometry, and the primary outcome was relative change in body fat mass, comparing treatment groups to placebo 
• Other outcomes included anthropometric measurements, food intake and blood and fecal biomarkers
• No diet or lifestyle intervention was employed 

Study results

B420™ clinically demonstrated (combination product vs placebo): 

• 4.5% reduction in total body fat mass
• 6.7% reduction in trunk fat 
• 1-inch (2.6-cm) reduction in waist circumference 

Subjects also consumed 11 to 15% fewer Calories in B420™ groups versus placebo. 

Bibliography