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| Name | Class |
|---|---|
| Atlantia Food Clinical Trials | INDUSTRY |
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This study is the first-in human study for the food ingredient BP-CBB and aims aims to build on the excellent safety and tolerability observed in the extensive food safety assessment performed for BP-CBB, as well as the consumer experience with using the product, and to set the scene for future human studies documenting the health-benefits of daily supplementation with BP-CBB for diverse populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test arm | Experimental | Receives Test product containing BP-CBB |
|
| Placebo arm | Placebo Comparator | Receives Placebo product without BP-CBB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BP-CBB | Dietary Supplement | Dietary supplement containing BP-CBB |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of once daily intake of the novel food ingredient BP-CBB in healthy adults | Incidence of all AEs per arm by product causality. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:
Has a history of drug and/or alcohol abuse.
Has known food allergies, history of Type I (IgE-mediated) food allergies, or hypersensitivity or other issues with foods or ingredients that would preclude intake of the Study Product (i.e. soya).
Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include:
Current or recent use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:
Current or recent (in the 4-weeks prior to Visit 1) use of prohibited nutritional or non-nutritional supplements that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited supplements include:
Regular (weekly) consumption of fermented food products (e.g. kefir, kombucha)
Planning to make significant dietary or lifestyle changes during the study period (e.g., travel, exercise, diet, change in body weight).
Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emma Harrington | Contact | +353 (0) 86-218-8787 | eharrington@atlantiatrials.com | |
| Emily Goodbody | Contact | +353 (0) 86-218-8787 | egoodbody@atlantiatrials.com |
| Name | Affiliation | Role |
|---|---|---|
| Martin Buckley, Professor | Atlantia Clinical Trials | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Clinical Trials | Recruiting | Cork | T23 R50R | Ireland |
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The Sponsor Bactolife
| Placebo |
| Dietary Supplement |
Receives dietary supplement without BP-CBB |
|