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| ID | Type | Description | Link |
|---|---|---|---|
| NL84650.091.23 | Other Identifier | METC Oost-Nederland |
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| Name | Class |
|---|---|
| Gelderse Vallei Hospital | OTHER |
| VLAG Graduate School | UNKNOWN |
| Alliance TU/e, WUR, UU, UMC Utrecht (EWUU) | UNKNOWN |
| Nutrition & Healthcare Alliance |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibre-UP tool: digital, personalized dietary advice to increase dietary fiber intake | Experimental | 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. |
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| Vegetable product (dried chicory root) to increase dietary fiber intake | Experimental | Subjects will consume 2 sachets with each 7.5 g of dried cubes of chicory root, which equals a total of 12.3 g of dietary fiber per day. Subjects can choose when and how they consume the vegetable product, for example sprinkle it over their meal, or include in existing recipes. |
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| Control | No Intervention | Subjects will follow their habitual diet during the preoperative period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary intervention | Other | Increase dietary fiber intake |
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| Measure | Description | Time Frame |
|---|---|---|
| Dietary fiber intake | Change in dietary fiber intake is assessed via two 24hr dietary recalls. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Stool pattern | Change in stool frequency per week and average stool consistency per week assessed using the Bristol Stool Chart. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Niels Klaassen, MSc | Contact | + 31 (0) 317 487 265 | niels.klaassen@wur.nl | |
| Dieuwertje EG Kok, PhD | Contact | + 31 (0) 317 485 901 | dieuwertje.kok@wur.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate | Recruiting | Arnhem | Gelderland | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34132738 | Background | Kok DE, Arron MNN, Huibregtse T, Kruyt FM, Bac DJ, van Halteren HK, Kouwenhoven EA, Wesselink E, Winkels RM, van Zutphen M, van Duijnhoven FJB, de Wilt JHW, Kampman E. Association of Habitual Preoperative Dietary Fiber Intake With Complications After Colorectal Cancer Surgery. JAMA Surg. 2021 Jun 16;156(9):1-10. doi: 10.1001/jamasurg.2021.2311. Online ahead of print. | |
| 32943128 |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| UNKNOWN |
| WholeFiber BV | UNKNOWN |
| Wageningen Food and Biobased Research (WFBR) | UNKNOWN |
| Meander Medical Center | OTHER |
| Rijnstate Hospital | OTHER |
A randomized controlled trial with three parallel arms consisting of two intervention arms and one control arm. Multicenter study conducted in collaboration with three participating hospitals, including Hospital Gelderse Vallei (Ede), Meander Medical Center (Amersfoort), and Rijnstate Hospital (Arnhem)
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Change in gastrointestinal symptoms measured with the Gastrointestinal Symptom Rating Scale (GSRS). Higher scores mean a worse outcome. |
| 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. | 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. | 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 microbial metabolite levels | Change in SCFA and indole concentrations determined by GC-MS/MS and LC-MS/MS in fecal samples. | 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. | 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. | From date of surgery until date of hospital discharge, assessed up to 90 days after surgery. |
| Ziekenhuis Gelderse Vallei | Recruiting | Ede | Gelderland | Netherlands |
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| Meander Medisch Centrum | Recruiting | Amersfoort | Utrecht | Netherlands |
|
| Background |
| Rijnaarts I, de Roos NM, Wang T, Zoetendal EG, Top J, Timmer M, Bouwman EP, Hogenelst K, Witteman B, de Wit N. Increasing dietary fibre intake in healthy adults using personalised dietary advice compared with general advice: a single-blind randomised controlled trial. Public Health Nutr. 2021 Apr;24(5):1117-1128. doi: 10.1017/S1368980020002980. Epub 2020 Sep 18. |
| 35573462 | Background | Rijnaarts I, de Roos NM, Wang T, Zoetendal EG, Top J, Timmer M, Hogenelst K, Bouwman EP, Witteman B, de Wit N. A high-fibre personalised dietary advice given via a web tool reduces constipation complaints in adults. J Nutr Sci. 2022 Apr 28;11:e31. doi: 10.1017/jns.2022.27. eCollection 2022. |
| 39295776 | Background | Puhlmann ML, Jokela R, van Dongen KCW, Bui TPN, van Hangelbroek RWJ, Smidt H, de Vos WM, Feskens EJM. Dried chicory root improves bowel function, benefits intestinal microbial trophic chains and increases faecal and circulating short chain fatty acids in subjects at risk for type 2 diabetes. Gut Microbiome (Camb). 2022 Apr 28;3:e4. doi: 10.1017/gmb.2022.4. eCollection 2022. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |