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

UAS Labs

Status

Completed

Conditions

Weight Management

Treatments

Other: Placebo capsule

Dietary Supplement: Lactobacillus gasseri BNR17™ capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT04260997

AFCRO-112

Details and patient eligibility

About

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.

Enrollment

125 patients

Sex

All

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.