Dietary Fiber Before Colorectal Cancer Surgery

NCT ID: NCT06212817

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-29
• Study Completion Date: 2026-05-31

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).

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dietary intervention

Intervention Type: OTHER

Increase dietary fiber intake

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.

Group Type: EXPERIMENTAL

Dietary intervention

Intervention Type: OTHER

Increase dietary fiber intake

Control

Subjects will follow their habitual diet during the preoperative period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dietary intervention

Increase dietary fiber intake

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gelderse Vallei Hospital

OTHER

Sponsor Role: collaborator

VLAG Graduate School

UNKNOWN

Sponsor Role: collaborator

Alliance TU/e, WUR, UU, UMC Utrecht (EWUU)

UNKNOWN

Sponsor Role: collaborator

Nutrition & Healthcare Alliance

UNKNOWN

Sponsor Role: collaborator

WholeFiber BV

UNKNOWN

Sponsor Role: collaborator

Wageningen Food and Biobased Research (WFBR)

UNKNOWN

Sponsor Role: collaborator

Meander Medical Center

OTHER

Sponsor Role: collaborator

Rijnstate Hospital

OTHER

Sponsor Role: collaborator

Wageningen University

OTHER

Sponsor Role: lead

Responsible Party

Dieuwertje Kok

Associate Professor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rijnstate

Arnhem, Gelderland, Netherlands

Site Status: RECRUITING

Ziekenhuis Gelderse Vallei

Ede, Gelderland, Netherlands

Site Status: RECRUITING

Meander Medisch Centrum

Amersfoort, Utrecht, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Niels Klaassen, MSc

Role: CONTACT

niels.klaassen@wur.nl

+ 31 (0) 317 487 265

Dieuwertje EG Kok, PhD

Role: CONTACT

dieuwertje.kok@wur.nl

+ 31 (0) 317 485 901

Facility Contacts

N. Hugen, MD, PhD

Role: primary

P. M. Kruyt, MD

Role: primary

G. Abis, MD, PhD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 34132738 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32943128 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35573462 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 39295776 (View on PubMed)

Other Identifiers

NL84650.091.23

Identifier Type: OTHER

Identifier Source: secondary_id

2023-16470

Identifier Type: -

Identifier Source: org_study_id