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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03781778
Other study ID # RG1003387
Secondary ID NCI-2018-0280210
Status Terminated
Phase Phase 2
First received
Last updated
Start date May 7, 2019
Est. completion date October 1, 2020

Study information

Verified date September 2022
Source Fred Hutchinson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II, randomized pilot trial studies the effect of the consumption of foods made with resistant starch compared to foods made with corn starch on biomarkers that may be related to colorectal cancer progression in stage I-III colorectal cancer survivors. Foods made with resistant starch may beneficially influence markers of inflammation, insulin resistance, and the composition of gut bacteria in colorectal cancer survivors.


Description:

Participants are randomized to 1 of 2 groups. GROUP I (INTERVENTION GROUP): Participants eat a diet consisting of resistant starch foods daily for 8 weeks. Study provided foods are in addition to their own usual daily diet. GROUP II (CONTROL GROUP): Participants eat a diet consisting of regular corn starch foods daily for 8 weeks. Study provided foods are in addition to their own usual daily diet.


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date October 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - History of diagnosed American Joint Committee on Cancer (AJCC) stage I-III colorectal adenocarcinoma. - Completed all treatment of colorectal adenocarcinoma within past 4-36 months. - Current Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (per physician). - Ability to consent and follow study protocol. Exclusion Criteria: - Active cancer. - Prior diagnosis of diabetes that is currently uncontrolled (defined as hemoglobin [Hgb] A1c > 8.0). - Active inflammatory bowel disease (i.e., patients who are symptomatic despite medical therapy). This includes irritable bowel syndrome, Crohn's disease, or any other inflammatory bowel disorder. - Known food allergy/intolerances to wheat, gluten, dairy or eggs. - Use of antibiotic(s) within the last 3 months prior to enrollment. - Women who are pregnant and/or breastfeeding. - Current body mass index (BMI) < 18.5 kg/m^2. - Uncontrolled constipation. - Inability to speak and fully understand English.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dietary Intervention (resistant starch)
Eat foods with resistant starch
Dietary Intervention (regular starch)
Eat foods with regular corn starch
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States Fred Hutch/University of Washington Cancer Consortium Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Fred Hutchinson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility: Accrual The accrual rate will be estimated with number of participants at full enrollment at 12 months. Up to 12 months
Primary Feasibility: Adherence The adherence endpoint pertains to adherence to the intervention and is defined as consuming 75% or more of study foods on 75% of days from baseline to 8 weeks. From start of intervention to ending intervention: up to 8 weeks
Primary Feasibility: Retention The retention endpoint is defined as at least 80% of enrolled participants providing blood and stool samples at the week 8 timepoint. From start of intervention to the 8-week timepoint
Secondary Variability of Biomarkers of Insulin Resistance and Inflammation (Adiponectin) Adiponectin was measured at baseline and week 8 (follow-up) and reported using descriptive statistics. Baseline to follow-up at week 8
Secondary Variability in Biomarkers of Insulin Resistance and Inflammation (C-reactive Protein, CRP) CRP was measured at baseline and week 8 (follow-up) and reported using descriptive statistics. Baseline to follow-up at week 8
Secondary Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA This measure assesses variability in gut microbial communities from human stool samples collected during the study by changes in alpha diversity and genera in response to the intervention. We will use multivariate and univeriate approaches to assess significant changes int he microbiome in response to the intervention. Baseline to follow-up at weeks 2 and 8
Secondary Variability in Gut Microbial Communities From Human Stool Samples -- BETA DIVERSITY This measure assesses variability in gut microbial communities from human stool samples collected during the study by changes in global microbial community (beta diversity) in response to the intervention. We will use multivariate and univeriate approaches to assess significant changes in the microbiome in response to the intervention. Baseline to followup at weeks 2 and 8
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