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Healthy SubjectNCT04211766

Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer

A study testing Dietary Fiber, Fish Oil and Comparator in people with Healthy Subject, run by Fred Hutchinson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subject
What is being tested?
Dietary Fiber, Fish Oil and Comparator
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
5 Jan 2021to 16 Aug 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy
  • Normal-overweight (body mass index [BMI] of 18-30 kg/m^2)
  • Women will be postmenopausal, with no menstrual period in 12 months
  • Non-smoking
  • Consume fiber intakes of less than < 20 g/d
  • White blood cell count 3,000-11,000/mm^3
Show all 14Show fewer
  • Platelet count 100,000-400,000 mm^3
  • Hematocrit 33-50% (women); 36-50% (men)
  • Bilirubin 0.2-1.3 mg/dL
  • Aspartate aminotransferase (AST) 0-35 U/L
  • Alanine aminotransferase (ALT) 0-40 U/L
  • Alkaline phosphatase 20-125 U/L
  • Creatinine =< 1.2 mg/dL
  • Potassium 3.5-5.0 mmol/L

Who cannot join

  • Chronic medical illness, history of gastrointestinal disorders (e.g., ulcerative colitis, Crohn disease, celiac sprue, hereditary nonpolyposis colorectal cancer [HNPCC], familial adenomatous polyposis, pancreatic disease, previous gastrointestinal resection, radiation or chemotherapy, and cancer (other than non-melanoma skin cancer)
  • Weight change greater than 4.5 kg within past year
  • Oral or intravenous (IV) antibiotic use within the past 3 months
  • Regular use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Smoking or use of cannabis products
  • Known allergy to fish
  • Intention to relocate out of study area within next 4 months

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Diet and the Colonic Exfoliome: A Novel, Non-Invasive Approach to Testing Interventions in Humans

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.

Read the detailed description

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.

Conditions
Healthy Subject
Being tested
Dietary Fiber, Fish Oil, Comparator
Keywords
Colon, Rectum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary FiberDietary supplement

    Also called Fiber

    Given fiber supplement

  • Fish OilDietary supplement

    Also called Oil, Fish, Seafood Oil

    Given fish oil supplement

  • ComparatorOther

    Also called placebo therapy, PLCB, sham therapy

    Given fiber supplement placebo

  • ComparatorOther

    Also called placebo therapy, PLCB, sham therapy

    Given fish oil supplement placebo (corn oil)

Study groups in NCT04211766
Study groupRoleWhat they receive
Cross-over Randomization 1: Fiber plus Fish Oil followed by ComparatorExperimentalParticipants 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)
Receives: Dietary Supplement: Dietary Fiber; Dietary Supplement: Fish Oil; Other: Comparator
Cross-over Randomization 2: Comparator followed by Fiber plus Fish OilExperimentalParticipants 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
Receives: Dietary Supplement: Dietary Fiber; Dietary Supplement: Fish Oil; Other: Comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to completion of the 2 study time periods

Secondary outcomes (2)

  1. 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.

    Measured: End of Fiber Plus Fish Oil Supplementation vs end of Comparator

  2. Compliance

    Serum Phospholipids - Eicosapentaenoic acid (EPA), concentration

    Measured: Average at the end of each intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2019
  2. Study start5 Jan 2021
  3. Primary completion16 Aug 2022
  4. Study completion16 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04211766
Sponsor's protocol ID
RG1006100
Other IDs
NCI-2019-07435, RG1006100, R21CA245456, 10327
Status last verified
Sep 2024
First submitted
20 Nov 2019
Last updated
27 Sep 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41461276

Questions about this trial

What is this clinical trial studying?

A study testing Dietary Fiber, Fish Oil and Comparator in people with Healthy Subject, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility and Retention for a Trial With Daily Doses of 35 g of Fiber and 6.2 g of EPA +DHA (and Corresponding Comparators) (time frame: Baseline to completion of the 2 study time periods). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04211766, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.

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