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

NCT04260997 | Completed

• 1 other identifier: AFCRO-112
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Other Outcomes (4)

• 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

Study Arms (2)

Oral Probiotic Product

EXPERIMENTAL

Dietary Supplement: Lactobacillus gasseri BNR17™ capsule

Placebo product

PLACEBO COMPARATOR

Other: Placebo capsule

Interventions

Lactobacillus gasseri BNR17™ capsule DIETARY_SUPPLEMENT

Once per day (QD), 12 weeks

Oral Probiotic Product

Placebo capsule OTHER

Once per day (QD), 12 weeks

Placebo product

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UAS Labs LLC: lead

Study Sites (1)

Atlantia Food Clinical Trials

Cork, Ireland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 7, 2020
• Study Start: July 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

IE (1)