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Completed

NCT Number: NCT04260997

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.

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Key information

Conditions

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlantia Food Clinical Trials

Cork, Ireland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus gasseri BNR17™ capsule

Dietary Supplement

Once per day (QD), 12 weeks

Placebo capsule

Other

Once per day (QD), 12 weeks

Primary outcomes

  1. Absolute change from baseline to week 12 in visceral adipose tissue (VAT)

    Time frame: 12 weeks

    VAT will be assessed using dual energy x-ray absorptiometry

Secondary outcomes

  1. Absolute change from baseline to week 12 in total fat mass

    Time frame: 12 weeks

  2. Absolute change from baseline to week 12 in total lean mass

    Time frame: 12 weeks

  3. Absolute change from baseline to week 12 in body weight

    Time frame: 12 weeks

  4. Absolute change from baseline to week 12 in waist circumference

    Time frame: 12 weeks

  5. Absolute change from baseline to week 12 in waist-to-hip ratio

    Time frame: 12 weeks

  6. Absolute change from baseline to week 12 in blood glucose

    Time frame: 12 weeks

  7. Absolute change from baseline to week 12 in HbA1c

    Time frame: 12 weeks

  8. Absolute change from baseline to week 12 in blood insulin

    Time frame: 12 weeks

  9. Absolute change from baseline to week 12 in hs-CRP

    Time frame: 12 weeks

Other outcomes

  1. Gastrointestinal symptom rating scale

    Time frame: 12 weeks

  2. Safety blood profile (clinical chemistry and full blood count)

    Time frame: 12 weeks

  3. Vitals (systolic blood pressure, diastolic blood pressure, heart rate and temperature)

    Time frame: 12 weeks

  4. Adverse events (frequency, severity and relatedness)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

UAS Labs LLC

Industry

Registry information

Official study title

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.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 7, 2020
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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