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NCT Number: NCT06212817

Dietary Fiber Before Colorectal Cancer Surgery

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rijnstate, Arnhem, Gelderland, Netherlands

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About this study

Rationale: Postoperative complications, affecting up to 50% of the patients with colorectal cancer (CRC) undergoing surgery, are associated with impaired quality of life and higher mortality rates. The investigators have previously shown an association between a higher preoperative dietary fiber intake and a lower risk of postoperative complications. Before large interventions aiming to evaluate potential causal relationships between dietary fiber and postoperative complications can be implemented, feasibility of increasing dietary fiber intake before CRC surgery needs to be explored.

Objective: To investigate the feasibility of increasing preoperative dietary fiber intake in CRC patients undergoing surgery via 1) personalized dietary advice (Vezel-UP tool), or 2) vegetable product containing natural fibers compared to 3) habitual diet (control group). Secondary objectives will be considered to generate preliminary (biological) data to support the design of a future large-scale intervention studies.

Study design: A randomized controlled trial with three groups: 1) Vezel-UP group, 2) vegetable product group, and 3) control group. The intervention period equals the time between diagnosis and surgery, which is on average ~4 weeks but will vary between individual patients depending on their characteristics (e.g., physical condition and tumor location) and waiting list.

Study population: 54 CRC patients who will undergo elective tumor resection.

Main study parameters/endpoints: The primary outcome is the change in dietary fiber intake, which is assessed via two 24hr dietary recalls at baseline and during and after the intervention. Secondary parameters are stool pattern, gastrointestinal symptoms, quality of life, fecal microbiota composition, fecal and plasma microbial metabolites levels (i.e., SCFA and indoles), and length of hospital stay.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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).

Treatment and study plan

Dietary Intervention

Other

Increase dietary fiber intake

Primary outcomes

  1. Dietary fiber intake

    Time frame: 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).

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

Secondary outcomes

  1. Stool pattern

    Time frame: 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).

    Change in stool frequency per week and average stool consistency per week assessed using the Bristol Stool Chart.

  2. Gastrointestinal symptoms

    Time frame: 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).

    Change in gastrointestinal symptoms measured with the Gastrointestinal Symptom Rating Scale (GSRS). Higher scores mean a worse outcome.

  3. Health-related quality of life

    Time frame: 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).

    Change in quality of life measured with the European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ-C30 & CR29). Global and functional health-related quality of life will be calculated, for which higher scores indicate better quality of life. Also symptom scales will be calculated, for which higher scores indicate higher presence or severity of a symptom.

  4. Fecal gut microbiota composition

    Time frame: 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).

    Measured using 16S rRNA amplicon sequencing in fecal samples.

  5. Fecal microbial metabolite levels

    Time frame: 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).

    Change in SCFA and indole concentrations determined by GC-MS/MS and LC-MS/MS in fecal samples.

  6. Plasma microbial metabolite levels

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

    Change in SCFA and indole concentrations will be determined by GC-MS/MS and LC-MS/MS in blood samples.

  7. Length of hospital stay

    Time frame: From date of surgery until date of hospital discharge, assessed up to 90 days after surgery.

    Time between surgery and hospital discharge in number of days based on data from medical records.

Study contacts

Contact information is provided by the study sponsor or research team.

Dieuwertje EG Kok, PhD

CONTACT

[email protected]

+ 31 (0) 317 485 901

Niels Klaassen, MSc

CONTACT

[email protected]

+ 31 (0) 317 487 265

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • Alliance TU/e, WUR, UU, UMC Utrecht (EWUU)
  • Gelderse Vallei Hospital
  • Meander Medical Center
  • Nutrition & Healthcare Alliance
  • Rijnstate Hospital
  • VLAG Graduate School
  • Wageningen Food and Biobased Research (WFBR)
  • WholeFiber BV

Registry information

Official study title

FiberUP in Clinical Practice: Increasing Preoperative Dietary Fiber Intake in Colorectal Cancer Patients.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 19, 2024
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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