Fiber to Reduce Colon Cancer in Alaska Native People
Ключови думи
Резюме
Описание
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.
1. 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[69] 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
2. 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.
Дати
| Последна проверка: | 10/31/2019 |
| Първо изпратено: | 01/17/2017 |
| Очаквано записване подадено: | 01/17/2017 |
| Първо публикувано: | 01/22/2017 |
| Изпратена последна актуализация: | 11/05/2019 |
| Последна актуализация публикувана: | 11/06/2019 |
| Действителна начална дата на проучването: | 12/10/2017 |
| Приблизителна дата на първично завършване: | 12/31/2021 |
| Очаквана дата на завършване на проучването: | 12/31/2021 |
Състояние или заболяване
Интервенция / лечение
Dietary Supplement: Digestible Starch
Dietary Supplement: Resistant Starch
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| 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: Digestible Starch Fully digestible amylopectin corn starch |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 40 Years Да се 40 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: Healthy AN volunteers (from GI standpoint) between 40-65 years (age at which colon cancer screening colonoscopy is recommended in this population) and BMI between 18-35 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. Exclusion criteria: These are detailed under Human Subjects. Participants will be ineligible if they have a history of familial adenomatous polyposis or hereditary non-polyposis colorectal cancer, or have previous colonoscopic evidence of inflammatory bowel disease or colon cancer. Also ineligible will be individuals with known renal, hepatic, or bleeding disorders; previous GI surgery resulting in disturbed gut function due to of loss of bowel or altered anatomy; or any form of chronic GI disease resulting in disturbed gut function, diarrhea, and malabsorption. Individuals with antibiotic use within the past 12 weeks, current steroids use, or on medical treatment for diabetes, will also be excluded. |
Резултат
Първични изходни мерки
1. colonic mucosal proliferation [4 weeks]
Вторични изходни мерки
1. colonic microbiota [4 weeks]
2. colonic secondary bile acids [4 weeks]
