Weight ManagementNCT04260997
Effect of a Probiotic, Lactobacillus Gasseri BNR17, on Body Composition and Weight Management in Overweight Adults
A study testing Lactobacillus gasseri BNR17™ capsule in people with Weight Management, run by UAS Labs LLC at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Management
- What is being tested?
- Lactobacillus gasseri BNR17™ capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jul 2020to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- Lactobacillus gasseri BNR17™ capsule, Placebo capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus gasseri BNR17™ capsuleDietary supplement
Once per day (QD), 12 weeks
Placebo capsuleOther
Once per day (QD), 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Oral Probiotic Product | Experimental | Not described Receives: Dietary Supplement: Lactobacillus gasseri BNR17™ capsule |
| Placebo product | Placebo comparator | Not described Receives: Other: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from baseline to week 12 in visceral adipose tissue (VAT)
VAT will be assessed using dual energy x-ray absorptiometry
Measured: 12 weeks
Secondary outcomes (9)
Absolute change from baseline to week 12 in total fat mass
Measured: 12 weeks
Absolute change from baseline to week 12 in total lean mass
Measured: 12 weeks
Absolute change from baseline to week 12 in body weight
Measured: 12 weeks
Absolute change from baseline to week 12 in waist circumference
Measured: 12 weeks
Absolute change from baseline to week 12 in waist-to-hip ratio
Measured: 12 weeks
Absolute change from baseline to week 12 in blood glucose
Measured: 12 weeks
Absolute change from baseline to week 12 in HbA1c
Measured: 12 weeks
Absolute change from baseline to week 12 in blood insulin
Measured: 12 weeks
Absolute change from baseline to week 12 in hs-CRP
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start1 Jul 2020
- Primary completion1 May 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- UAS Labs LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260997
- Sponsor's protocol ID
- AFCRO-112
- Status last verified
- Sep 2021
- First submitted
- 5 Feb 2020
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04260997
- Acronym / sponsor ID
- AFCRO-112
- Conditions
- Weight Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- UAS Labs LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Probiotic Product | Experimental | Dietary Supplement: Lactobacillus gasseri BNR17™ capsule |
| Placebo product | Placebo comparator | Other: Placebo capsule |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus gasseri BNR17™ capsuleOnce per day (QD), 12 weeks | Dietary supplement | Oral Probiotic Product |
| Placebo capsuleOnce per day (QD), 12 weeks | Other | Placebo product |
Primary outcome
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
9 secondary outcomes
Absolute change from baseline to week 12 in total fat mass
Time frame: 12 weeks
Absolute change from baseline to week 12 in total lean mass
Time frame: 12 weeks
Absolute change from baseline to week 12 in body weight
Time frame: 12 weeks
Absolute change from baseline to week 12 in waist circumference
Time frame: 12 weeks
Absolute change from baseline to week 12 in waist-to-hip ratio
Time frame: 12 weeks
Absolute change from baseline to week 12 in blood glucose
Time frame: 12 weeks
Absolute change from baseline to week 12 in HbA1c
Time frame: 12 weeks
Absolute change from baseline to week 12 in blood insulin
Time frame: 12 weeks
Absolute change from baseline to week 12 in hs-CRP
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus gasseri BNR17™ capsule in people with Weight Management, run by UAS Labs LLC at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change from baseline to week 12 in visceral adipose tissue (VAT) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.