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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-07435 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| RG1006100 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| R21CA245456 | U.S. NIH Grant/Contract | View source | |
| 10327 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Texas A&M University | OTHER |
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This trial studies how fiber and fish oil supplements affect the metabolism and activities of colon cells in healthy individuals. Diet is an important risk factor for colorectal cancer, and several dietary components important in colorectal cancer prevention are modified by gut microbial metabolism. Giving fiber and fish oil supplements may inhibit the growth of gut cells and ultimately reduce risk of colorectal cancer.
Participants are randomized to receive two dietary interventions in assigned random order. They either receive the dietary fiber supplement and fish oil supplement orally (PO) daily or they receive a fiber control and corn oil supplement daily for 30 days during the first intervention period. Then they enter a washout period for 60 days when they do not receive any treatment. After that they complete the second intervention period during which they receive the other intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cross-over Randomization 1: Fiber plus Fish Oil followed by Comparator | Experimental | Participants first received a fiber supplement and a fish oil supplement PO daily for 30 days (Period 1). Participants entered a washout period for at least 60 days. For period 2 they received similarly packaged comparator (maltodextrin and corn oil) |
|
| Cross-over Randomization 2: Comparator followed by Fiber plus Fish Oil | Experimental | Participants first received the comparator (maltodextrin and corn oil) supplement PO daily for 30 days (Period 1). Participants enter a washout period for at least 60 days. For period 2 they received the fiber supplement and a fish oil supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Fiber | Dietary Supplement | Given fiber supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and Retention for a Trial With Daily Doses of 35 g of Fiber and 6.2 g of EPA +DHA (and Corresponding Comparators) | This grant is an R21 with the intent to provide preliminary data to propose a trial with a larger sample size and adequate statistical power. | Baseline to completion of the 2 study time periods |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Differentially Expressed Exfoliome Genes at p<0.01 | Poly A+ RNA was isolated from exfoliated cells in stool, and libraries generated from stool RNA and sequenced on an Illumina HiSeq 2500 platform. Intestinal exfoliome gene sequencing data from the end of each intervention period were analyzed using differential expression (DE) analysis. Count data were aligned, and sample libraries were filtered and normalized; 25,118 detected features were filtered to keep any feature with >20 cpm in 73% of samples in at least one of the groups; this resulted in 1000 genes. DE analysis between Fiber Plus Fish Oil Supplement vs the Comparator at the end time point was performed using edgeR with a paired design (Robinson et al, Bioinformatics 2010;26:139). Data are presented as number of DE genes significant at p < 0.01 (without multiple test correction). Upregulated genes indicate higher gene expression with Fiber Plus Fish Oil vs the Comparator and downregulated genes indicate lower gene expression with Fiber Plus Fish Oil vs the Comparator. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johanna Lampe | 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41461276 | Derived | Fan YY, Salinas ML, Mullens DA, Davidson LA, Goldsby JS, Ivanov IV, Jayaraman A, Cai JJ, Levy L, Hullar MA, Navarro SL, Lampe JW, Chapkin RS. Pesco-Vegetarian Food Components Promote Colonocyte Ferroptosis in Preclinical Mouse Models and a Randomized Crossover Trial in Healthy Human Adults. J Nutr. 2026 Feb;156(2):101287. doi: 10.1016/j.tjnut.2025.101287. Epub 2025 Dec 27. |
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Before randomization to determine the crossover order of supplements (active-washout-comparison, or comparison-washout-active), consented participants had a blood draw. Samples were sent to CLIA-certified Quest Labs for kidney/liver function tests as part of eligibility criteria. Two of the 38 were ineligible based on the lab test criteria. Additionally, 1 person decided they did not want to enter the trial and was not randomized.
Recruitment occurred December 2020 thru March 2022 via ads, fliers and social media in the Seattle area. We received 243 screening questionnaires; 88 were incomplete. Of 155 completed, 95 were ineligible (61.3%). We contacted the 60 eligible; 43 attended orientation; 38 signed consent. Three were not randomized (2 ineligible based on abnormal clinical lab tests at baseline and 1 withdrew because of stool collection). Overall, we met planned recruitment goals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cross-over Randomization 1: Fiber Plus Fish Oil Followed by Comparator | Period 1: Fiber and Fish oil supplements (30 days) Washout: at least 60 days Period 2: Comparator supplements (30 days) |
| FG001 | Cross-over Randomization 2: Comparator Followed by Fiber Plus Fish Oil | Period 1: Comparator supplements (30 days) Washout: at least 60 days Period 2: Fiber and Fish oil supplements (30 days) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cross-over Randomization 1: Fiber Plus Fish Oil Followed by Comparator | Participants received a fiber supplement and fish oil supplement PO daily for 30 days. After a washout period, of at least 60 days, they received the comparator supplements (also for 30 days) |
| BG001 | Cross-over Randomization 2: Comparator Followed by Fiber Plus Fish Oil |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 and Retention for a Trial With Daily Doses of 35 g of Fiber and 6.2 g of EPA +DHA (and Corresponding Comparators) | This grant is an R21 with the intent to provide preliminary data to propose a trial with a larger sample size and adequate statistical power. | All participants who consented and started the intervention. | Posted | Count of Participants | Participants | Baseline to completion of the 2 study time periods |
|
Only during study participation (4 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cross-over Randomization 1: Fiber Plus Fish Oil Followed by Comparator | Period 1: participants receive fiber supplement and fish oil supplements PO daily on days 1-30. Washout: at least 60 days. Period 2: participants receive the comparators supplements also PO daily on days 90-120. |
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This is a pilot study with limited funding (R21 mechanism) thus sample size is small.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Johanna Lampe | Fred Hutchinson Cancer Center | (206) 667-6580 | JLampe@fredhutch.org |
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| 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 | Oct 20, 2022 | Aug 10, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 29, 2020 | Jul 19, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| Fish Oil | Dietary Supplement | Given fish oil supplement |
|
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| Comparator | Other | Given fiber supplement placebo |
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| Comparator | Other | Given fish oil supplement placebo (corn oil) |
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| End of Fiber Plus Fish Oil Supplementation vs end of Comparator |
| Compliance | Serum Phospholipids - Eicosapentaenoic acid (EPA), concentration | Average at the end of each intervention period |
Participants received the comparator supplements PO daily for 30 days. After a washout period, of at least 60 days, they received the fiber supplement and fish oil supplement (also for 30 days) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
For Period 1: participants receive comparator supplements PO daily on days 1-30. Participants enter a washout period for at least 60 days. For Period 2: participants receive fiber supplement and fish oil supplement also PO daily on days 90-120. |
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| Secondary | Number of Differentially Expressed Exfoliome Genes at p<0.01 | Poly A+ RNA was isolated from exfoliated cells in stool, and libraries generated from stool RNA and sequenced on an Illumina HiSeq 2500 platform. Intestinal exfoliome gene sequencing data from the end of each intervention period were analyzed using differential expression (DE) analysis. Count data were aligned, and sample libraries were filtered and normalized; 25,118 detected features were filtered to keep any feature with >20 cpm in 73% of samples in at least one of the groups; this resulted in 1000 genes. DE analysis between Fiber Plus Fish Oil Supplement vs the Comparator at the end time point was performed using edgeR with a paired design (Robinson et al, Bioinformatics 2010;26:139). Data are presented as number of DE genes significant at p < 0.01 (without multiple test correction). Upregulated genes indicate higher gene expression with Fiber Plus Fish Oil vs the Comparator and downregulated genes indicate lower gene expression with Fiber Plus Fish Oil vs the Comparator. | All participants who completed both the Fiber Plus Fish Oil Supplement and the Comparator intervention periods in this crossover study and had stools at the end of each intervention period were included in the analysis. RNA-Seq data from stool for 29 participants were analyzed for differential gene expression comparing the end of each intervention period. | Posted | Number | number of genes at p<0.01 | End of Fiber Plus Fish Oil Supplementation vs end of Comparator | genes | genes |
|
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| Secondary | Compliance | Serum Phospholipids - Eicosapentaenoic acid (EPA), concentration | Posted | Mean | Standard Deviation | mg/L | Average at the end of each intervention period |
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| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Cross-over Randomization 2: Comparator Followed by Fiber Plus Fish Oil | Period 1: participants receive the comparators supplements PO daily on days 1-30. Washout: at least 60 days. Period 2: participants receive fiber supplement and fish oil supplements also PO daily on days 90-120. | 0 | 16 | 0 | 16 | 0 | 16 |
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| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |
| D009821 | Oils |
| D008055 | Lipids |
| Title | Measurements |
|---|---|
|