Dietary Fiber Before Colorectal Cancer Surgery

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

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).

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Dietary intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Niels Klaassen, MSc; Phone Number: + 31 (0) 317 487 265; Email: niels.klaassen@wur.nl
• Study Contact Backup: Name: Dieuwertje EG Kok, PhD; Phone Number: + 31 (0) 317 485 901; Email: dieuwertje.kok@wur.nl

Study Locations

• Netherlands
  • Gelderland
    • Arnhem, Gelderland, Netherlands
      • Recruiting
      • Rijnstate
      • Contact: N. Hugen, MD, PhD
    • Ede, Gelderland, Netherlands
      • Recruiting
      • Ziekenhuis Gelderse Vallei
      • Contact: P. M. Kruyt, MD
  • Utrecht
    • Amersfoort, Utrecht, Netherlands
      • Recruiting
      • Meander Medisch Centrum
      • Contact: G. Abis, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fibre-UP tool: digital, personalized dietary advice to increase dietary fiber intake; 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; Increase dietary fiber intake
Experimental: Vegetable product (dried chicory root) to increase dietary fiber intake; 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; Increase dietary fiber intake
No Intervention: Control; Subjects will follow their habitual diet during the preoperative period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool pattern	Change in stool frequency per week and average stool consistency per week assessed using the Bristol Stool Chart.	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	Change in gastrointestinal symptoms measured with the Gastrointestinal Symptom Rating Scale (GSRS). Higher scores mean a worse outcome.	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	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.	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	Measured using 16S rRNA amplicon sequencing in fecal samples.	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	Change in SCFA and indole concentrations determined by GC-MS/MS and LC-MS/MS in fecal samples.	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).
Plasma microbial metabolite levels	Change in SCFA and indole concentrations will be determined by GC-MS/MS and LC-MS/MS in blood samples.	2 time points: T0 (at baseline) and T2 (at the end of intervention period, on average after 4 weeks).
Length of hospital stay	Time between surgery and hospital discharge in number of days based on data from medical records.	From date of surgery until date of hospital discharge, assessed up to 90 days after surgery.

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Surgery; Colorectal cancer; Postoperative complications; Gut microbiota; Prehabilitation; Dietary fiber
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Postoperative Complications; Therapeutics; Nutrition Therapy; Diet Therapy
• Other Study ID Numbers: 2023-16470; NL84650.091.23 (Other Identifier: METC Oost-Nederland)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No