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| ID | Type | Description | Link |
|---|---|---|---|
| 2011/836 | Other Identifier | REK Sør-Øst |
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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
| Finnish Institute for Health and Welfare | OTHER_GOV |
| University Hospital, Akershus | OTHER |
| Norwegian Cancer Society |
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The current study is designed to gain a better understanding of the role of a healthy diet aimed at dampening inflammation and oxidative stress on long-term disease outcomes and survival in colorectal cancer patients. Since previous research on the role of diet for colorectal cancer survivors is limited, the study may be of great importance for this cancer population.
Men and women aged 50-80 years diagnosed with primary invasive colorectal cancer (Stage I-III) are invited to this randomized controlled, parallel two-arm trial 2-9 months after curative surgery. The intervention group (n = 250) receives an intensive dietary intervention lasting for 12 months and a subsequent maintenance intervention for 14 years. The control group (n = 250) receives no dietary intervention other than standard clinical care. Both groups are offered equal general advice of physical activity. Patients are followed-up at 6 months and 1, 3, 5, 7, 10 and 15 years after baseline. The study center is located at the Department of Nutrition, University of Oslo, and patients are recruited from two hospitals within the South-Eastern Norway Regional Health Authority. Primary outcomes are disease-free survival and overall survival. Secondary outcomes are time to recurrence, cardiovascular disease-free survival, compliance to the dietary recommendations and the effects of the intervention on new comorbidities, intermediate biomarkers, nutrition status, physical activity, physical function and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | The intervention group (n = 250) receives an intensive dietary intervention lasting for 12 months and a subsequent maintenance intervention for 14 years. Both groups are offered equal general advice of physical activity. |
|
| Control group | Other | The control group (n = 250) receives no dietary intervention other than standard clinical care. Both groups are offered equal general advice of physical activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norwegian food based dietary guidelines | Other | several means will be applied to guide participarts to cohere to the dietary guidelines including access to clinical nutritionists, free food, food discounts, cooking courses, cookbook/recipies, study website, organized physical activity, etc |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | Disease-free survival (DFS) (events are defined as detection of local recurrence or metastasis or any second cancer or death from any cause) | 5, 10 and 15 years |
| Overall survival | Overall survival (OS) (event is defined as death from any cause) | 5, 10 and 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to recurrence | Events are defined as detection of local recurrence or metastasis | up to 15 years |
| CVD -free survival | Events of CVD (ICD-10; chapter I) or death from any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rune Blomhoff, Professor | University of Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University Hospital | Lørenskog | 1478 | Norway | |||
| University of Oslo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28137255 | Result | Henriksen HB, Raeder H, Bohn SK, Paur I, Kvaerner AS, Billington SA, Eriksen MT, Wiedsvang G, Erlund I, Faerden A, Veierod MB, Zucknick M, Smeland S, Blomhoff R. The Norwegian dietary guidelines and colorectal cancer survival (CRC-NORDIET) study: a food-based multicentre randomized controlled trial. BMC Cancer. 2017 Jan 30;17(1):83. doi: 10.1186/s12885-017-3072-4. | |
| 34999327 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 13, 2026 | Jun 19, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 16, 2026 | Jun 16, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| OTHER |
| The Research Council of Norway | OTHER |
Parallel randomized clinical trial
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| up to 15 years |
| CRC-specific survival | death due to CRC | up to 15 years |
| Total cancer-specific survival | death due to CRC or any other cancer | up to 15 years |
| Inflammatory disease-specific survival | death due to inflammatory disease | up to 15 years |
| Cardiovascular (CVD)-specific survival | death due to CVD | up to 15 years |
| New morbidity of other diet-related chronic diseases | e.g. ischemic coronary heart disease, cerebrovascular disease, thromboembolic disease, type 2 diabetes, obesity, hypertension and chronic obstructive pulmonary disease | up to 15 years |
| Dietary intake and nutritional status | Questionnaires, food records, clinical consultation | up to 15 years |
| Physical activity and function | Questionnaires, arm band, physical tests | up to 15 years |
| Nutrition biomarkers | e.g., carotenoids, fatty acids, 25-hydroxy vitamin D etc | up to 15 years |
| Body composition | DXA, CT, BIA | up to 15 years |
| Anthropometric measures | eg weight, waist and hip circumference | up to 15 years |
| Biomarkers for inflammation and oxidative stress | e.g. isoprostanes, cytokines | up to 15 years |
| Transcription- and epigenetic profiles | sequencing and arrays | up to 15 years |
| Biomarkers for cardiovascular disease, metabolic syndrome, type 2-diabetes, thromboembolic disease and cancer | e.g. blood pressure, total/LDLcholesterol, HbA1c, CRP, IL-6, IL-10, TNFα | up to 15 years |
| Health related quality of life and fatigue | Questionnaires | up to 15 years |
| Oslo |
| 0316 |
| Norway |
| Oslo University Hospital | Oslo | Norway |
| Henriksen C, Paur I, Pedersen A, Kvaerner AS, Raeder H, Henriksen HB, Bohn SK, Wiedswang G, Blomhoff R. Agreement between GLIM and PG-SGA for diagnosis of malnutrition depends on the screening tool used in GLIM. Clin Nutr. 2022 Feb;41(2):329-336. doi: 10.1016/j.clnu.2021.12.024. Epub 2021 Dec 18. |
| 34024541 | Result | Alavi DH, Henriksen HB, Lauritzen PM, Kvaerner AS, Sakinis T, Langleite TM, Henriksen C, Bohn SK, Paur I, Wiedswang G, Smeland S, Blomhoff R. Quantification of adipose tissues by Dual-Energy X-Ray Absorptiometry and Computed Tomography in colorectal cancer patients. Clin Nutr ESPEN. 2021 Jun;43:360-368. doi: 10.1016/j.clnesp.2021.03.022. Epub 2021 Apr 15. |
| 29854408 | Result | Henriksen HB, Berntsen S, Paur I, Zucknick M, Skjetne AJ, Bohn SK, Henriksen C, Smeland S, Carlsen MH, Blomhoff R. Validation of two short questionnaires assessing physical activity in colorectal cancer patients. BMC Sports Sci Med Rehabil. 2018 May 29;10:8. doi: 10.1186/s13102-018-0096-2. eCollection 2018. |
| 29545734 | Result | Henriksen HB, Carlsen MH, Paur I, Berntsen S, Bohn SK, Skjetne AJ, Kvaerner AS, Henriksen C, Andersen LF, Smeland S, Blomhoff R. Relative validity of a short food frequency questionnaire assessing adherence to the Norwegian dietary guidelines among colorectal cancer patients. Food Nutr Res. 2018 Feb 22;62. doi: 10.29219/fnr.v62.1306. eCollection 2018. |
| 41611086 | Derived | Eklo RR, Alavi DT, Konglevoll DM, Kolle A, Henriksen HB, Rising R, Blomhoff R, Olsen T. Predictive equations commonly used in the clinic underestimate resting energy expenditure compared with whole-room indirect calorimetry in colorectal cancer survivors. Am J Clin Nutr. 2026 Mar;123(3):101209. doi: 10.1016/j.ajcnut.2026.101209. Epub 2026 Jan 27. |
| 40346639 | Derived | Henriksen HB, Kolle A, Stenling A, Paur I, Bohn SK, Broto P, Tronstad TS, Blomhoff R, Berntsen S. Spillover effect of a dietary intervention on physical activity in a randomized controlled trial with colorectal cancer patients. Int J Behav Nutr Phys Act. 2025 May 9;22(1):54. doi: 10.1186/s12966-025-01757-0. |
| 40180023 | Derived | Nordengen AL, Krutto A, Kvaerner AS, Alavi DT, Henriksen HB, Kolle A, Henriksen C, Smeland S, Bohn SK, Zheng C, Shaposhnikov S, Collins AR, Blomhoff R. Plant-based diet and oxidative stress-induced DNA damage in post-surgery colorectal cancer patients: Results from a randomized controlled trial. Free Radic Biol Med. 2025 Jun;233:240-249. doi: 10.1016/j.freeradbiomed.2025.03.047. Epub 2025 Apr 1. |
| 37739688 | Derived | Alavi DT, Henriksen HB, Lauritzen PM, Zucknick M, Bohn SK, Henriksen C, Paur I, Smeland S, Blomhoff R. Effect of a one-year personalized intensive dietary intervention on body composition in colorectal cancer patients: Results from a randomized controlled trial. Clin Nutr ESPEN. 2023 Oct;57:414-422. doi: 10.1016/j.clnesp.2023.06.037. Epub 2023 Jul 11. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |