Back to resultsEffect of a Probiotic, Lactobacillus Gasseri BNR17, on Body Composition and Weight Management in Overweight Adults
Primary Purpose
Weight Management
Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Lactobacillus gasseri BNR17™ capsule
Placebo capsule
Sponsored by
About this trial
This is an interventional treatment trial for Weight Management
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.
Sites / Locations
- Atlantia Food Clinical Trials
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Oral Probiotic Product
Placebo product
Arm Description
Outcomes
Primary Outcome Measures
Absolute change from baseline to week 12 in visceral adipose tissue (VAT)
VAT will be assessed using dual energy x-ray absorptiometry
Secondary Outcome Measures
Absolute change from baseline to week 12 in total fat mass
Absolute change from baseline to week 12 in total lean mass
Absolute change from baseline to week 12 in body weight
Absolute change from baseline to week 12 in waist circumference
Absolute change from baseline to week 12 in waist-to-hip ratio
Absolute change from baseline to week 12 in blood glucose
Absolute change from baseline to week 12 in HbA1c
Absolute change from baseline to week 12 in blood insulin
Absolute change from baseline to week 12 in hs-CRP
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04260997
Brief Title
Effect of a Probiotic, Lactobacillus Gasseri BNR17, on Body Composition and Weight Management in Overweight Adults
Official 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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UAS Labs LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral Probiotic Product
Arm Type
Experimental
Arm Title
Placebo product
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus gasseri BNR17™ capsule
Intervention Description
Once per day (QD), 12 weeks
Intervention Type
Other
Intervention Name(s)
Placebo capsule
Intervention Description
Once per day (QD), 12 weeks
Primary Outcome Measure Information:
Title
Absolute change from baseline to week 12 in visceral adipose tissue (VAT)
Description
VAT will be assessed using dual energy x-ray absorptiometry
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Absolute change from baseline to week 12 in total fat mass
Time Frame
12 weeks
Title
Absolute change from baseline to week 12 in total lean mass
Time Frame
12 weeks
Title
Absolute change from baseline to week 12 in body weight
Time Frame
12 weeks
Title
Absolute change from baseline to week 12 in waist circumference
Time Frame
12 weeks
Title
Absolute change from baseline to week 12 in waist-to-hip ratio
Time Frame
12 weeks
Title
Absolute change from baseline to week 12 in blood glucose
Time Frame
12 weeks
Title
Absolute change from baseline to week 12 in HbA1c
Time Frame
12 weeks
Title
Absolute change from baseline to week 12 in blood insulin
Time Frame
12 weeks
Title
Absolute change from baseline to week 12 in hs-CRP
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Gastrointestinal symptom rating scale
Time Frame
12 weeks
Title
Safety blood profile (clinical chemistry and full blood count)
Time Frame
12 weeks
Title
Vitals (systolic blood pressure, diastolic blood pressure, heart rate and temperature)
Time Frame
12 weeks
Title
Adverse events (frequency, severity and relatedness)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Atlantia Food Clinical Trials
City
Cork
Country
Ireland
12. IPD Sharing Statement
Learn more about this trial
Effect of a Probiotic, Lactobacillus Gasseri BNR17, on Body Composition and Weight Management in Overweight Adults
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