NCT06212817

Brief Summary

The aim of this randomized controlled trial is to investigate the feasibility of increasing preoperative dietary fiber intake in individuals with colorectal cancer who will undergo surgery. This will be done using 1) digital personalized dietary advice or 2) a dried vegetable product compared to 3) habitual diet (control).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

April 29, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

1.7 years

First QC Date

December 5, 2023

Last Update Submit

November 14, 2025

Conditions

Colorectal Cancer

Keywords

Dietary fiberPostoperative complicationsSurgeryGut microbiotaColorectal cancerPrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Dietary fiber intake

    Change in dietary fiber intake is assessed via two 24hr dietary recalls.

    3 time points: T0 (at baseline), T1 (after 2 weeks of intervention), and T2 (at the end of intervention period, on average after 4 weeks).

Secondary Outcomes (7)

  • Stool pattern

    3 time points: T0 (at baseline), T1 (after 2 weeks of intervention), and T2 (at the end of intervention period, on average after 4 weeks).

  • Gastrointestinal symptoms

    3 time points: T0 (at baseline), T1 (after 2 weeks of intervention), and T2 (at the end of intervention period, on average after 4 weeks).

  • Health-related quality of life

    3 time points: T0 (at baseline), T1 (after 2 weeks of intervention), and T2 (at the end of intervention period, on average after 4 weeks).

  • Fecal gut microbiota composition

    3 time points: T0 (at baseline), T1 (after 2 weeks of intervention), and T2 (at the end of intervention period, on average after 4 weeks).

  • Fecal microbial metabolite levels

    3 time points: T0 (at baseline), T1 (after 2 weeks of intervention), and T2 (at the end of intervention period, on average after 4 weeks).

  • +2 more secondary outcomes

Study Arms (3)

Fibre-UP tool: digital, personalized dietary advice to increase dietary fiber intake

EXPERIMENTAL

Subjects will receive personalized dietary advice (PDA) based on their habitual food pattern (as assessed using a food frequency questionnaire) and preferences. Based on a previously developed algorithm, the PDA provides fiber-rich alternatives for currently used low-fiber products, close to subjects' current eating behavior, to help increase dietary fiber intake. This PDA will be provided using an online web-portal.

Other: Dietary intervention

Vegetable product (dried chicory root) to increase dietary fiber intake

EXPERIMENTAL

Subjects will consume 2 sachets with each 7.5 g of dried cubes of chicory root, which equals a total of 12.3 g of dietary fiber per day. Subjects can choose when and how they consume the vegetable product, for example sprinkle it over their meal, or include in existing recipes.

Other: Dietary intervention

Control

NO INTERVENTION

Subjects will follow their habitual diet during the preoperative period.

Interventions

Dietary interventionOTHER

Increase dietary fiber intake

Fibre-UP tool: digital, personalized dietary advice to increase dietary fiber intakeVegetable product (dried chicory root) to increase dietary fiber intake

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years;
  • Being diagnosed with CRC and planned to undergo elective CRC resection;

You may not qualify if:

  • Previously have had a large abdominal resection, excluding appendectomy and cholecystectomy;
  • Diagnosed with Crohn's disease, Ulcerative Colitis, Celiac Disease;
  • Currently having a stoma;
  • Known allergic reactions to plants from the Asteraceae (Compositae) family (e.g., lettuce, daisies, sunflowers, artichokes, sage, tarragon, chamomile, chicory etc.);
  • Currently following a strict diet and unwilling or unable to change (e.g., gluten free or ketogenic diet);
  • Currently using fiber supplements, prebiotics and/or probiotics and unwilling to stop using these for the duration of the intervention;
  • Having a habitual dietary fiber intake \>30 g/day for women and \>40 g/day for men, measured with a food frequency questionnaire;
  • Dementia or other cognitive disabilities that makes it impossible to fill out questionnaires correctly;
  • Illiteracy (inability to read and understand Dutch).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rijnstate

Arnhem, Gelderland, Netherlands

RECRUITING

Ziekenhuis Gelderse Vallei

Ede, Gelderland, Netherlands

RECRUITING

Meander Medisch Centrum

Amersfoort, Utrecht, Netherlands

RECRUITING

Related Publications (4)

  • Kok DE, Arron MNN, Huibregtse T, Kruyt FM, Bac DJ, van Halteren HK, Kouwenhoven EA, Wesselink E, Winkels RM, van Zutphen M, van Duijnhoven FJB, de Wilt JHW, Kampman E. Association of Habitual Preoperative Dietary Fiber Intake With Complications After Colorectal Cancer Surgery. JAMA Surg. 2021 Jun 16;156(9):1-10. doi: 10.1001/jamasurg.2021.2311. Online ahead of print.

    PMID: 34132738BACKGROUND

  • Rijnaarts I, de Roos NM, Wang T, Zoetendal EG, Top J, Timmer M, Bouwman EP, Hogenelst K, Witteman B, de Wit N. Increasing dietary fibre intake in healthy adults using personalised dietary advice compared with general advice: a single-blind randomised controlled trial. Public Health Nutr. 2021 Apr;24(5):1117-1128. doi: 10.1017/S1368980020002980. Epub 2020 Sep 18.

    PMID: 32943128BACKGROUND

  • Rijnaarts I, de Roos NM, Wang T, Zoetendal EG, Top J, Timmer M, Hogenelst K, Bouwman EP, Witteman B, de Wit N. A high-fibre personalised dietary advice given via a web tool reduces constipation complaints in adults. J Nutr Sci. 2022 Apr 28;11:e31. doi: 10.1017/jns.2022.27. eCollection 2022.

    PMID: 35573462BACKGROUND

  • Puhlmann ML, Jokela R, van Dongen KCW, Bui TPN, van Hangelbroek RWJ, Smidt H, de Vos WM, Feskens EJM. Dried chicory root improves bowel function, benefits intestinal microbial trophic chains and increases faecal and circulating short chain fatty acids in subjects at risk for type 2 diabetes. Gut Microbiome (Camb). 2022 Apr 28;3:e4. doi: 10.1017/gmb.2022.4. eCollection 2022.

    PMID: 39295776BACKGROUND

MeSH Terms

Conditions

Colorectal NeoplasmsPostoperative Complications

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Central Study Contacts

Niels Klaassen, MSc

CONTACT

+ 31 (0) 317 487 265niels.klaassen@wur.nl

Dieuwertje EG Kok, PhD

CONTACT

+ 31 (0) 317 485 901dieuwertje.kok@wur.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A randomized controlled trial with three parallel arms consisting of two intervention arms and one control arm. Multicenter study conducted in collaboration with three participating hospitals, including Hospital Gelderse Vallei (Ede), Meander Medical Center (Amersfoort), and Rijnstate Hospital (Arnhem)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, PhD

Study Record Dates

First Submitted

December 5, 2023

First Posted

January 19, 2024

Study Start

April 29, 2024

Primary Completion

January 1, 2026

Study Completion

May 1, 2026

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

NL(3)