Clinical trial NCT06212817: Dietary Fiber Before Colorectal Cancer Surgery
Official title: FiberUP in Clinical Practice: Increasing Preoperative Dietary Fiber Intake in Colorectal Cancer Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Keywords: Dietary fiber
Postoperative complications
Surgery
Gut microbiota
Colorectal cancer
Prehabilitation
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Gelderse Vallei Hospital
name: VLAG Graduate School
name: Alliance TU/e, WUR, UU, UMC Utrecht (EWUU)
name: Nutrition & Healthcare Alliance
name: WholeFiber BV
name: Wageningen Food and Biobased Research (WFBR)
First posted: 2024-01-19
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial with three parallel arms consisting of two intervention arms and one control arm.
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Dietary fiber intake
timeFrame: 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:
measure: Stool pattern
timeFrame: 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).
measure: Gastrointestinal symptoms
timeFrame: 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).
measure: Health-related quality of life
timeFrame: 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).
measure: Fecal gut microbiota composition
timeFrame: 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).
measure: Fecal microbial metabolite levels
timeFrame: 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).
measure: Plasma microbial metabolite levels
timeFrame: 2 time points: T0 (at baseline) and T2 (at the end of intervention period, on average after 4 weeks).
measure: Length of hospital stay
timeFrame: From date of surgery until date of hospital discharge, assessed up to 90 days after surgery.
Other outcomes:
Locations:
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
state: Gelderland
Study officials:
References:
citation: 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.
citation: 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.
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.
citation: 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.