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).
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
54
Increase dietary fiber intake
Rijnstate
Arnhem, Gelderland, Netherlands
Ziekenhuis Gelderse Vallei
Ede, Gelderland, Netherlands
Meander Medisch Centrum
Amersfoort, Utrecht, Netherlands
Dietary fiber intake
Change in dietary fiber intake is assessed via two 24hr dietary recalls.
Time frame: 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).
Stool pattern
Change in stool frequency per week and average stool consistency per week assessed using the Bristol Stool Chart.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
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Fecal microbial metabolite levels
Change in SCFA and indole concentrations determined by GC-MS/MS and LC-MS/MS in fecal samples.
Time frame: 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.
Time frame: 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.
Time frame: From date of surgery until date of hospital discharge, assessed up to 90 days after surgery.