Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02802 | Other Identifier | NCI / CTRP | |
| 10079 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Terminated due to expiration of funding
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (resistant starch foods) | Experimental | Patients eat a diet consisting of resistant starch foods daily for 8 weeks. |
|
| Group II (foods with regular corn starch) | Active Comparator | Patients eat a diet consisting of regular corn starch foods daily for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Intervention (resistant starch) | Other | Eat foods with resistant starch |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Accrual | The accrual rate will be estimated with number of participants at full enrollment at 12 months. | Up to 12 months |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Variability in Biomarkers of Insulin Resistance and Inflammation (C-reactive Protein, CRP) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marian Neuhouser | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 1-Active (Resistant Starch) | Participants receive daily study snack foods prepared with resistant starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days. |
| FG001 | 2-Control (Regular Starch) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 4, 2020 |
Not provided
Blinded, block randomization based on sex and BMI.
Not provided
Not provided
Assignment to the active versus control group will be blinded using a computer program and will be designated as "diet A" and "diet B". Investigators will be unblinded once the study and data analyses have been completed.
| Dietary Intervention (regular starch) | Other | Eat foods with regular corn starch |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
CRP was measured at baseline and week 8 (follow-up) and reported using descriptive statistics. |
| Baseline to follow-up at week 8 |
| 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 |
| 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 |
Participants receive daily study snack foods prepared with regular starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days. |
| Started Intervention |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
at time of enrollment
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 1-Active (Resistant Starch) | Participants receive daily study snack foods prepared with resistant starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days. |
| BG001 | 2-Control (Regular Starch) | Participants receive daily study snack foods prepared with regular starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Height | Median | Full Range | cm |
| |||||||||||||||||
| Weight | Median | Full Range | kg |
| |||||||||||||||||
| Body Mass Index (BMI) | Median | Full Range | kg/m^2 |
| |||||||||||||||||
| BMI Category | Count of Participants | Participants |
| ||||||||||||||||||
| T-stage | Participants were staged clinically by the interdisciplinary clinical oncology team per American Joint Committee on Cancer Staging Criteria for colorectal carcinoma (AJCC 8th edition). AJCC Stage Groupings I-III for colorectal carcinoma were eligible for the trial. Prognostic outcomes are considered better for lower stages and worse for higher stages. | Count of Participants | Participants |
| |||||||||||||||||
| N-stage | Participants were staged clinically by the interdisciplinary clinical oncology team per American Joint Committee on Cancer Staging Criteria for colorectal carcinoma (AJCC 8th edition). AJCC Stage Groupings I-III for colorectal carcinoma were eligible for the trial. Prognostic outcomes are considered better for lower stages and worse for higher stages. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility: Accrual | The accrual rate will be estimated with number of participants at full enrollment at 12 months. | Posted | Count of Participants | Participants | 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. | Overall number of participants analyzed for the adherence measure: 7 (per protocol) | Posted | Count of Participants | Participants | 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. | All participants enrolled, in accordance with protocol and Statistical Analysis Plan | Posted | Count of Participants | Participants | 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. | Of the 10 participants enrolled to the study, blood was collected at the baseline and week 8 follow-up timepoints on just 5 participants. | Posted | Mean | Standard Deviation | ug/mL | 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. | Of the 10 participants enrolled to the study, blood was collected at the baseline and week 8 followup timepoints on just 5 participants. | Posted | Mean | Standard Deviation | mg/L | 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. | Of the 10 participants enrolled to this study, fecal samples were collected at baseline and followup for 7 participants. Of these 7 participants, one participant on Arm 1 dropped out of the study after week 2 hence the week 8 followup fecal was not obtained. For the remaining 6 participants, fecal samples from all three time-points were analyzed. | Posted | Mean | Standard Deviation | Relative abundance | 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. | Analysis limitation: due to low participant recruitment, there was insufficient number of stool samples available to detect and compute beta diversity. | Posted | Baseline to followup at weeks 2 and 8 |
|
|
From start of intervention to ending the intervention: up to 8 weeks.
Method of assessment: weekly participant-completed questionnaire. The number of participants (n=7) analyzed for adverse events ("number at risk" below) is fewer than the number enrolled (n=10) because 3 participants withdrew consent prior to starting the intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1-Active (Resistant Starch) | Participants receive daily study snack foods prepared with resistant starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG001 | 2-Control (Regular Starch) | Participants receive daily study snack foods prepared with regular starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days. | 0 | 4 | 0 | 4 | 4 | 4 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gassiness | Gastrointestinal disorders | Systematic Assessment |
| ||
| Bloating | Gastrointestinal disorders | Systematic Assessment |
| ||
| Increased frequency of bowel movements | Gastrointestinal disorders | Systematic Assessment |
| ||
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| Loose stool | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marian L. Neuhouser, PhD | Fred Hutchinson Cancer Research Center | 2066674797 | mneuhous@fredhutch.org |
| Sep 28, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D000084922 | Resistant Starch |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Normal weight |
|
| Overweight |
|
| Obese I |
|
| Obese II+ |
|
| T1 |
|
| T2 |
|
| T3 |
|
| T4a |
|
| T4b |
|
| N1 |
|
| N1a |
|
| N1b |
|
| N1c |
|
| N2 |
|
| N2a |
|
| N2b |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|