Effect of a Probiotic, Lactobacillus Gasseri BNR17, on Body Composition and Weight Management in Overweight Adults

A Randomised, Double-Blinded, Parallel, Placebo-Controlled Study Investigating the Effect of a Probiotic, Lactobacillus Gasseri BNR17, on Body Composition and Weight Management in Overweight Adults.

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 Overview

• Status: Completed
• Conditions: Weight Management
• Intervention / Treatment: Dietary supplement: Lactobacillus gasseri BNR17™ capsule; Other: Placebo capsule

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland
    • Atlantia Food Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent;
• Aged between 25 and 65 years inclusive;
• Body mass index between 25.0 to 29.9 Kg/m2, inclusive;
• Waist-hip ratio of ≥0.91 for males and ≥0.81 for females;
• Sedentary lifestyle, exercising ≤2 times/week;
• Good general health, as determined by the investigator;
• Willing to consume the investigational product daily for the duration of the study;
• Outside the healthy parameters of visceral adipose tissue, defined as 762 cm3 for males and 256 cm3 for females.

Exclusion Criteria:

• Females who are pregnant, lactating or wish to become pregnant during the study;
• Participant regularly takes probiotic supplements, or has within the 4-weeks prior to randomisation or plans to during the study;
• Participant is hypersensitive to any of the components of the investigational product;
• Participant is severely immuno-compromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or has underwent chemotherapy or radiotherapy within the last year);
• Participant has Type 1 or Type 2 Diabetes Mellitus;
• Participant has a history of bariatric surgery;
• Participant has taken anti-obesity medication or supplements in the 12-weeks prior to randomisation or plans to during the study;
• Participant is actively or has recently (3 months prior to randomisation) participated in a weight loss program or weight change of 3 kg during the past 3 months;
• Participant has a life-threatening illness;
• Participant is on a glucose lowering medication, anti-psychotic drugs or any medication that the investigator determines could impact the results of the study; participant has commenced use, within 3-months of randomisation, anti-hypertensive drugs, anti-depressive drugs, statin or any other medication that the investigator determines could impact the results of the study;
• Participant has a history of co-existing gastrointestinal, and/or gynecological, and/or urologic pathology (e.g. colon cancer, colitis, Crohn's Disease, Celiac, Endometriosis, prostate cancer) or lactose intolerance;
• Participant has a recent history of drug and/or alcohol abuse at the time of enrolment;
• Participant is currently, or planning to participate in another study during the study period;
• Participant has a history of non-compliance;
• Participant has taken antibiotics in the 12-weeks prior to randomisation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo product	Other: Placebo capsule; Once per day (QD), 12 weeks
Experimental: Oral Probiotic Product	Dietary supplement: Lactobacillus gasseri BNR17™ capsule; Once per day (QD), 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change from baseline to week 12 in visceral adipose tissue (VAT)	VAT will be assessed using dual energy x-ray absorptiometry	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Absolute change from baseline to week 12 in total fat mass	12 weeks
Absolute change from baseline to week 12 in total lean mass	12 weeks
Absolute change from baseline to week 12 in body weight	12 weeks
Absolute change from baseline to week 12 in waist circumference	12 weeks
Absolute change from baseline to week 12 in waist-to-hip ratio	12 weeks
Absolute change from baseline to week 12 in blood glucose	12 weeks
Absolute change from baseline to week 12 in HbA1c	12 weeks
Absolute change from baseline to week 12 in blood insulin	12 weeks
Absolute change from baseline to week 12 in hs-CRP	12 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Gastrointestinal symptom rating scale	12 weeks
Safety blood profile (clinical chemistry and full blood count)	12 weeks
Vitals (systolic blood pressure, diastolic blood pressure, heart rate and temperature)	12 weeks
Adverse events (frequency, severity and relatedness)	12 weeks

Collaborators and Investigators

• Sponsor: UAS Labs LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overweight; Body Weight
• Other Study ID Numbers: AFCRO-112

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No