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NCT03028831 · ClinicalTrials.gov registry record · NA
Fiber to Reduce Colon Cancer in Alaska Native People
A NA study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- NA
- Development phase
- 48
- Enrollment target
NCT03028831 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 48 participants.
The verdict
NCT03028831, a NA study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
Study Summary
Alaska native people (AN) have the highest recorded incidence and death rate from colon cancer in the world (\>90:100,000). We hypothesize that the AN, despite their high consumption of anti-inflammatory and antineoplastic n-3 fish oils, are at increased risk of colon cancer because of colonic butyrate deficiency resulting from their remarkably low consumption of fiber-containing foods. We hypothesize that fiber supplementation of their usual diet will result in a bloom of butyrate producing microbes in the colon, resulting in increased butyrate production, which will suppress their high microbial secondary bile acid production, antagonize the actions of other food (smoked fish) and environmental carcinogens (tobacco, alcohol), and interact with the high circulating levels of n-3 fish oils to suppress colonic inflammation and cancer risk. In order to investigate this, we will conduct a randomized double-blinded 4-week clinical trial in up to 100 randomizable healthy, middle-aged AN undergoing screening colonoscopy, with the objective of obtaining 60 completed interventions. The interventions will consist of either a high-dose soluble fiber supplement given as a drink, together with their usual diet which currently contains about 15g total fiber/d, or to a control digestible starch drink plus their usual diet. The primary endpoint will be a clinically significant reduction in Ki67 proliferative colonic mucosal biomarkers of cancer risk. Microbiome and metabolome mechanisms responsible for the anticipated changes in mucosal biomarkers will also be investigated. Our results in extreme risk AN will be further evaluated by comparison to similar measurements previously made in minimal risk rural Africans and intermediate risk African Americans. Our results will be used to provide the scientific basis for a definitive large-scale high-fiber supplementation study (to achieve \>50g total fiber/d) to suppress adenomatous polyp recurrence following colonoscopy.
Interventions
- DIETARY_SUPPLEMENT 70g of fully digestible starch amylopectin corn starch
- DIETARY_SUPPLEMENT Resistant starch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2017-12-11 |
| Est. Completion | 2022-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03028831
The ClinicalTrials.gov registry entry for NCT03028831 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 70g of fully digestible starch amylopectin corn starch is the first listed.
NCT03028831 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03028831 about?
NCT03028831 is a clinical study titled "Fiber to Reduce Colon Cancer in Alaska Native People". Alaska native people (AN) have the highest recorded incidence and death rate from colon cancer in the world (\>90:100,000). We hypothesize that the AN, despite their high consumption of anti-inflammatory and antineoplastic n-3 fish oils, are at increased risk of colon cancer because of colonic butyr...
What is the current status of trial NCT03028831?
This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2017-12-11. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT03028831?
The interventions under investigation include: 70g of fully digestible starch amylopectin corn starch (DIETARY_SUPPLEMENT), Resistant starch (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03028831?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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