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 (WholeFiber) compared to 3)…
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Postoperative complications affect up to 50% of the colorectal cancer (CRC)
patients undergoing surgery, and are associated with impaired quality of life
and higher mortality rates. We have shown that higher preoperative dietary
fiber intake is associated with a lower risk of postoperative complications. To
follow-up on our previous observational study, we would like to investigate the
potential causality of the relationship between dietary fiber and postoperative
complications. However, it is yet unknown which method is effective and
feasible for improving preoperative dietary fiber intake in CRC patients.
Study 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 (WholeFiber) compared
to 3) habitual diet (control group).
Study design
A randomized controlled trial with three groups: 1) Vezel-UP group, 2)
WholeFiber 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.
Intervention
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 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.
2) WholeFiber group: subjects will consume 2 sachets with each 7.5 g of
WholeFiberTM per day, which equals 12.3 g of dietary fiber per day.
WholeFiberTM consists of dried cubes of chicory root. Subjects can choose when
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.
Study burden and risks
This study has a negligible risk for subjects, as all advised fiber-rich
products (Vezel-UP group) and the vegetable product (WholeFiber group) are
commercially available and are deemed safe for consumption. Previous studies
have shown that both methods of increasing dietary fiber intake were well
tolerated by subjects in terms of abdominal complaints. Also, the burden of
this study is limited as questionnaires and fecal sample collection can be
completed at home. In most cases, visits to the hospitals for blood collection
will coincide with an existing appointment in the hospital of this patient.
This intervention study will not change in any way subjects* treatment for CRC.
Stippeneng 4
Wageningen 6708 WE
NL
Stippeneng 4
Wageningen 6708 WE
NL
Listed location countries
Age
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).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06212817 |
| CCMO | NL84650.091.23 |