Dietary Fiber Before Colorectal Cancer Surgery

Wageningen University

Status: Enrolling

Conditions: Colorectal Cancer

Treatments: Other: Dietary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06212817

NL84650.091.23 (Other Identifier)

2023-16470

Details and patient eligibility

About

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).

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 3 patient groups

Fibre-UP tool: digital, personalized dietary advice to increase dietary fiber intake

Experimental group

Description:

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.

Treatment:

Other: Dietary intervention

Vegetable product (dried chicory root) to increase dietary fiber intake

Experimental group

Description:

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.

Treatment:

Other: Dietary intervention

Control

No Intervention group

Description:

Subjects will follow their habitual diet during the preoperative period.