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FiberUP

FiberUP in clinical practice - FiberUP

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53209
Enrollment
54
Registered
2023-06-06
Start date
2024-04-29
Completion date
Unknown
Last updated
2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer bowel cancer

Interventions

1) Vezel-UP group: 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 previousl
and how they consume WholeFiberTM, for example sprinkle it over their meal, or include in existing recipes. 3) control group: subjects will following their habitual diet during preoperatieve period.

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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).

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Netherlands

Contacts

Public ContactDEG Kok

Wageningen Universiteit

dieuwertje.kok@wur.nl+ 31 (0) 317 485 901

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)