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

NCT ID: NCT04260997

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-09-01

Brief Summary

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.

Conditions

Weight Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oral Probiotic Product

Group Type: EXPERIMENTAL

Lactobacillus gasseri BNR17™ capsule

Intervention Type: DIETARY_SUPPLEMENT

Once per day (QD), 12 weeks

Placebo product

Group Type: PLACEBO_COMPARATOR

Placebo capsule

Intervention Type: OTHER

Once per day (QD), 12 weeks

Interventions

Lactobacillus gasseri BNR17™ capsule

Once per day (QD), 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo capsule

Once per day (QD), 12 weeks

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UAS Labs LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Atlantia Food Clinical Trials

Cork, , Ireland

Countries

Ireland

Other Identifiers

AFCRO-112

Identifier Type: -

Identifier Source: org_study_id