Dietary Fiber Before Colorectal Cancer Surgery
ConditionColorectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWageningen University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years;
Being diagnosed with CRC and planned to undergo elective CRC resection;
Disqualifiers
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.);
Trial design
Design model
Parallel
Treatments tested in this trial
Dietary intervention
Other interventionIncrease dietary fiber intake
Treatment groups
54 Participants
are divided into 3 treatment groupsGroup A: Fibre-UP tool: digital, personalized dietary advice to increase dietary fiber intakeExperimental treatment 1 intervention
Group B: Vegetable product (dried chicory root) to increase dietary fiber intakeExperimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).Secondary outcomes
1
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).2
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).3
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).4
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Wageningen University
Lead sponsor
Gelderse Vallei Hospital
Collaborator
VLAG Graduate School
Collaborator
Alliance TU/e, WUR, UU, UMC Utrecht (EWUU)
Collaborator
Nutrition & Healthcare Alliance
Collaborator
WholeFiber BV
Collaborator
Wageningen Food and Biobased Research (WFBR)
Collaborator
Meander Medical Center
Collaborator
Rijnstate Hospital
Collaborator
Source ClinicalTrials.gov