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Lactobacillus gasseri BNR17â„¢ 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 BNR17â„¢ 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 BNR17â„¢ or placebo once daily for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Probiotic Product | Experimental |
| |
| Placebo product | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus gasseri BNR17â„¢ capsule | Dietary Supplement | Once per day (QD), 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline to week 12 in visceral adipose tissue (VAT) | VAT will be assessed using dual energy x-ray absorptiometry | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Food Clinical Trials | Cork | Ireland |
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| Placebo capsule | Other | Once per day (QD), 12 weeks |
|
| 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 |
| Absolute change from baseline to week 12 in blood glucose | 12 weeks |
| Absolute change from baseline to week 12 in HbA1c | 12 weeks |
| Absolute change from baseline to week 12 in blood insulin | 12 weeks |
| Absolute change from baseline to week 12 in hs-CRP | 12 weeks |
| 12 weeks |
| Adverse events (frequency, severity and relatedness) | 12 weeks |