FiberUP in clinical practice

Recruiting

• Conditions: colorectal cancer; 10017991; 10017998

• Registration Number: NL-OMON53209
• Lead Sponsor: Wageningen Universiteit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 54

Inclusion Criteria

Adult colorectal cancer patients who are recently diagnosed and planned to
undergo elective resection to remove the tumor.

Exclusion Criteria

A patient who meets any of the following criteria will be excluded from
participation in this study:
• Previously have had a large abdominal resection, excluding appendectomy and
cholecystectomy;
• Diagnosed with Crohn*s disease, Ulcerative Colitis, Coeliac 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the change in dietary fiber intake, which is assessed<br /><br>via two 24hr dietary recalls at baseline and during and after the intervention. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are stool pattern, quality of life, fecal microbiota<br /><br>composition, fecal and plasma microbial metabolites levels (i.e., SCFA and<br /><br>indoles), and length of hospital stay. These secondary objectives will be<br /><br>included to generate preliminary (biological) data to support the design of a<br /><br>future intervention studies by further understanding the underlying biological<br /><br>mechanisms related to postoperative complications and provide necessary data<br /><br>for sample size calculations.</p><br>