Dietary Fiber Before Colorectal Cancer Surgery

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06212817
• Other study ID #: 2023-16470
• Secondary ID: NL84650.091.23
• Status: Recruiting
• Phase: N/A
• Start date: April 29, 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Wageningen University
• Contact: Niels Klaassen, MSc
• Phone: + 31 (0) 317 487 265
• Email: niels.klaassen[@]wur.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Dietary intervention
Increase dietary fiber intake

Locations

Country	Name	City	State
Netherlands	Ziekenhuis Gelderse Vallei	Ede	Gelderland

Sponsors (7)

Lead Sponsor	Collaborator
Wageningen University	Alliance TU/e, WUR, UU, UMC Utrecht (EWUU), Gelderse Vallei Hospital, Nutrition & Healthcare Alliance, VLAG Graduate School, Wageningen Food and Biobased Research (WFBR), WholeFiber BV

Country where clinical trial is conducted

Netherlands, 

References & 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. — View Citation

Puhlmann, M., Jokela, R., Van Dongen, K., Bui, T., Hangelbroek, R., Smidt, H., . . . Feskens, E. (2022). 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, 3, E4. doi:10.1017/gmb.2022.4

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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.