Lactobacillus gasseri BNR17™ has shown promise in several pre-clinical and randomized controlled clinical trials for weight management outcomes. The current randomized, double-blind, placebo-controlled, parallel-arm trial will further assess L. gasseri BNR17™ on body composition and weight management, and in a study population that is distinct to prior randomized controlled trials on the strain. The study will recruit 126 overweight adult participants who will be randomly assigned to consume L. gasseri BNR17™ or placebo once daily for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
125
Once per day (QD), 12 weeks
Once per day (QD), 12 weeks
Atlantia Food Clinical Trials
Cork, Ireland
Absolute change from baseline to week 12 in visceral adipose tissue (VAT)
VAT will be assessed using dual energy x-ray absorptiometry
Time frame: 12 weeks
Absolute change from baseline to week 12 in total fat mass
Time frame: 12 weeks
Absolute change from baseline to week 12 in total lean mass
Time frame: 12 weeks
Absolute change from baseline to week 12 in body weight
Time frame: 12 weeks
Absolute change from baseline to week 12 in waist circumference
Time frame: 12 weeks
Absolute change from baseline to week 12 in waist-to-hip ratio
Time frame: 12 weeks
Absolute change from baseline to week 12 in blood glucose
Time frame: 12 weeks
Absolute change from baseline to week 12 in HbA1c
Time frame: 12 weeks
Absolute change from baseline to week 12 in blood insulin
Time frame: 12 weeks
Absolute change from baseline to week 12 in hs-CRP
Time frame: 12 weeks
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