Fiber to Reduce Colon Cancer in Alaska Native People
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|ClinicalTrials.gov Identifier: NCT03028831|
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : November 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Dietary Supplement: 70g of fully digestible starch amylopectin corn starch Dietary Supplement: Resistant starch||Not Applicable|
Randomization for the double blind, placebo controlled, clinical trial: Recruitment will continue until 60 volunteers have completed the intervention study. Based on previous experience with similar studies, we anticipate 20% of screened patients to be ineligible or drop out, which means, so we plan on consenting and screening approximately 100 potential participants. Baseline data from these participants will be retained. Individuals will be randomized via minimisation (based on age, sex, polypectomy, high fish consumption, and BMI - factors that might influence microbiota composition and function)) to either the resistant starch (RS) group or the control digestible starch (DS) group upon completion of the Stabilization Period.
- RS Group: Participants will continue with their usual diet plus fiber supplement given as a daily dose of 70g high-amylose maize starch (HAM-RS, HI-MAIZE®260: Ingredion Incorporated, Bridgewater, NJ), which contains 42g of type 2 resistant starch, for 4 weeks. Data from previous studies suggests that their usual diet will contain approximately 13g dietary fiber/day, chiefly insoluble, indicating that total fiber intake would be approx. 55g/d. Supplements will be pre-weighed out in batches from the same source and kept in airtight containers. The supplement may be taken as a single or divided dose dissolved in 250ml water, low fat milk, or orange juice
- DS (Control) Group participants will continue on their usual diet, plus 70g of fully digestible starch (waxy corn starch comprised of amylopectin, AMIOCA® corn starch, Ingredion Incorporated, Bridgewater, NJ ) weighed out, analyzed, and prepared as previously. The RS and control supplements will appear and taste similar, allowing for coding and distribution in a double-blind fashion. The supplements will be equicaloric.
Interventions will include fecal and colonic content sampling for measurement of the microbiome and metabolome, and flexible sigmoidoscopy to obtain mucosal biopsies before and after the dietary supplementation.
Monitoring During the Clinical Trial: This will follow the scheme laid out on Figure 7. On day 0, participants will visit the clinic and will be asked to save their first fecal sample using our standard operating procedure developed and proven to be effective in our last study. They will then be given their first supplement drink made up in their vehicle of choice, and taken with a standard meal provided by the diet kitchen. During the trial, they will be instructed on the use of a simple diary to be completed at home. This will record the major food items consumed each day, the timing and completion of drink supplements, as well as the bowel function questionnaire to assess daily GI tolerance, i.e. abdominal discomfort, distension, gas, bowel frequency, nausea, vomiting. They will be asked to return to the clinic for a follow-up appointment on day 7, 14 and 21 in order to repeat the fecal and breath tests described above. At the same time, body weight will be monitored using one scale. At the end of 4 weeks, participants will be asked to return to the clinic for repeat of the colonic sampling performed at baseline.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized Controlled Trial of Resistant Starch to Reduce Colon Cancer Risk in Alaska Native People.|
|Actual Study Start Date :||December 11, 2017|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
Active Comparator: Resistant Starch
70g high-amylose maize starch which contains 42g of type 2 resistant starch
Dietary Supplement: Resistant starch
70g high-amylose maize starch
Placebo Comparator: Digestible Starch
70g of fully digestible starch comprised of amylopectin corn starch.
Dietary Supplement: 70g of fully digestible starch amylopectin corn starch
Fully digestible amylopectin corn starch
- colonic mucosal proliferation [ Time Frame: 4 weeks ]biomarker of cancer risk
- colonic microbiota [ Time Frame: 4 weeks ]fecal and colonic microbiota analysis
- colonic secondary bile acids [ Time Frame: 4 weeks ]fecal and colonic conjugated bile acid analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028831
|Contact: Stephen J O'Keefefirstname.lastname@example.org|
|Contact: Annette Wilsonemail@example.com|
|United States, Alaska|
|Alaskan Native Tribal Health Consortium||Recruiting|
|Anchorage, Alaska, United States, 99508|
|Contact: Timothy Thomas, MD 907-729-3095 tkthomas@ANTHC.org|
|Contact: Kathy Koller, PhD 907 729 3095 firstname.lastname@example.org|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Stephen J O'Keefe, MD 412-648-7217 email@example.com|
|Contact: Annette Wilson, PhD 4126487402 firstname.lastname@example.org|
|Study Director:||Gabriela Riscuta||National Cancer Institute (NCI)|