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Resistant Starch for Colon Cancer

N/A
Waitlist Available
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Inclusion Criteria: Healthy AN volunteers (from GI standpoint) between 40-70 years (age at which colon cancer screening colonoscopy is recommended in this population) and BMI between 18-40 Kg/m2. It should be noted that in our previous study, we found no difference in the responses of the key parameters (mucosal biomarkers, butyrate and secondary bile acid producers, fecal SCFA and bile acids) to increased fiber diets between those with normal body weight, those overweight, and those who were obese (Nature Comm Supplement). Patients who have, or have had noncancerous polyps removed previously by colonoscopy will be eligible. Alaska Native race will be defined as those eligible to receive health care through the Alaska Tribal Health System.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial will test whether a high-dose soluble fiber supplement, given as a drink, can reduce the Ki67 proliferative colonic mucosal biomarkers of cancer risk in Alaska native people, who have the highest recorded incidence and death rate from colon cancer in the world.

Eligible Conditions
  • Colon Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
colonic mucosal proliferation
Secondary outcome measures
colonic microbiota
colonic secondary bile acids

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Resistant StarchActive Control1 Intervention
70g high-amylose maize starch which contains 42g of type 2 resistant starch
Group II: Digestible StarchPlacebo Group1 Intervention
70g of fully digestible starch comprised of amylopectin corn starch.

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,714 Previous Clinical Trials
16,346,453 Total Patients Enrolled
Alaska Native Tribal Health ConsortiumOTHER
14 Previous Clinical Trials
8,177 Total Patients Enrolled
Gabriela RiscutaStudy DirectorNational Cancer Institute (NCI)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the target demographic of this trial exceeding 25 years?

"The minimum age of admission for this particular medical study is 40 years old, with the maximum set at 70."

Answered by AI

Are there any vacancies in this clinical trial for participants?

"The clinical trial is currently recruiting and was published on December 11th, 2017; the information posted online has been recently updated as of February 8th 2021."

Answered by AI

How many participants are currently being evaluated in this clinical experiment?

"Affirmative. Upon inspection of the information provided on clinicaltrials.gov, it is evident that this medical trial began recruitment in December 2017 and was recently updated in February 2022. The study requires 60 participants between two appointed sites."

Answered by AI

May I partake in this clinical investigation?

"This clinical trial is recruiting 60 colon cancer patients aged between 40 and 70. To be accepted, applicants must be in a healthy gastrointestinal state with body mass index ranging from 18-40 Kg/m2. Previous studies have found no difference in responses to fibre diets amongst those of various weights including the overweight or obese. Those who had noncancerous polyps removed previously are also eligible for this trial, as well as Alaska Native individuals enrolled in their Tribal Health System program."

Answered by AI
Recent research and studies
~7 spots leftby Mar 2025