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| Name | Class |
|---|---|
| Anderson Advanced Ingredients | INDUSTRY |
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This is a randomized, double-blind, placebo-controlled, parallel-group clinical study. The primary objective is to assess the changes in the small intestinal (SI) metagenomic profile of healthy participants without any known gastrointestinal disorders from baseline to endpoint in response to the prebiotic intervention (FiberSmart). The study population are adults (n=30) who will ingest either the FiberSmart or a matched Placebo daily for 21 days. Both products will be referred to as the Investigational Product (IP) in the study procedures section. While prebiotics are widely used for gut health, their specific impact on the small intestinal ecosystem remains largely uncharacterized compared to the large intestine. Understanding their impact on the upper GI tract can lead to new insights into their mechanisms of action. Given the critical role of the small intestine in metabolism and immunity, the study utilizes the SIMBA capsule to measure novel changes in the small intestine along with traditional measurements from stool samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prebiotic | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FiberSmart | Dietary Supplement | Anderson Global's FiberSmart Formulation, branded as FiberSmart, which is a soluble tapioca fiber powder (resistant dextrin). Natural Product Number 80091222. The product is a prebiotic supplement intended for oral consumption. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary | To evaluate changes in the small intestinal microbiome of healthy participants from baseline to the end of the 21-day FiberSmart intervention, as assessed by differential abundance testing of bacterial taxa across sampling timepoints using the SIMBA capsule. Shotgun metagenomic sequencing will be used to characterize taxonomic and functional shifts in the small intestinal microbiome. | Baseline (day 0) to the end of Intervention (day 21) |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary 1 | Assess the difference in metagenomic profile between the small intestine and stool within participants in response to the FiberSmart intervention from baseline, to the end of intervention using the SIMBA capsule. | Baseline (day 0) to the end of Intervention (day 21) |
| Secondary 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isaac Wong | Contact | 5872472660 | clinical@nimblesci.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Life Science Innovation Hub | Calgary | Alberta | T2L1Y8 | Canada |
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| Placebo | Other | Placebo: Microcrystalline Cellulose, matches for appearance and taste, and is inert without prebiotic effects. |
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Assess the microbial composition (superimposability of PLS-DA mapping) of the SI from samples collected by the SIMBA capsule |
| Baseline (day 0) to the end of Intervention (day 21) |
| Secondary 3 | Explore the potential impact FiberSmart has on bowel movement frequency and texture correlation using daily questionnaires | Baseline (day 0) to the end of Intervention (day 21) |