Probiotics and Weight management

Probiotics and Weight Management

About the Study This studywas a single-centre, randomised, double-blind, placebo-controlled, parallel study in overweight volunteers. The study population was aged between 25 and 65 years old with a body mass index between 25.0 to29.9Kg/m2, awaist-hip ratioof ≥0.91 for males and ≥0.81 for females, having a sedentary lifestyle (exercising less than 2 times per week). The participants should be outside the healthy parameters of visceral adipose tissue, defined as 762 cm3 for males and 256 cm3 for females, assessed by DXA scans. Other exclusion criteria were also considered. Participantswere recruited through Atlantia’s database, social media platforms, General Practitioners offices and advertisements in local media. Participants who met the eligibility criteria wererandomised(ratio1:1) tooneof thetwo treatment groups prior writing informed consent: a capsule containing the optimal dose as per the Sponsors pre-clinical results and placebo. Each eligible participant was assigned a randomisation number in chronological order, which corresponds to one of the two groups. The relationship between the randomisation number and the group assignment was unknown to the

DESIGN

ETHICS

RECRUITMENT

CONDUCT

ANALYSIS

REPORTING

clinical research team, the sponsor, study site staff, or the participants. The study involved visits over a 15-week period, per participant, including a run- in phase and the intervention period. Participants were instructed to consume one capsule per day, before breakfast for the duration of the study, they were retrained if their compliance was not suitable. A fasting blood sample was collected at various visits. Additional plasma and serumwere stored at -80oC at Atlantia’s facilities, for future exploratory analysis of inflammatory and satiety biomarkers. Participants were provided with a stool collection kit and instructions for collecting and storing at home. Participants returned the stool sample and they were stored at -80oC, for future exploratory analysis including sequencing, SCFA analysis and detection of the strain.

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