Clinical Trials Directory

Trials / Terminated

TerminatedNCT03781778

Pilot Trial of Resistant Starch in Stage I-III Colorectal Cancer Survivors

Randomized, Controlled Trial of Resistant Starch in Stage I-Ill Colorectal Cancer Survivors Pilot Study: The Fiber for Health After Cancer Study

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
10 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERDietary Intervention (resistant starch)Eat foods with resistant starch
OTHERDietary Intervention (regular starch)Eat foods with regular corn starch
OTHERQuestionnaire AdministrationAncillary studies

Timeline

Start date
2019-05-07
Primary completion
2020-10-01
Completion
2020-10-01
First posted
2018-12-20
Last updated
2022-10-06
Results posted
2021-12-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03781778. Inclusion in this directory is not an endorsement.