The Norwegian Dietary Guidelines and Colorectal Cancer Survival Study (CRC-NORDIET)

The Norwegian Dietary Guidelines and Colorectal Cancer Survival Study: A Food-based Multicentre Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Norwegian food based dietary guidelines

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 503
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Lørenskog, Norway, 1478
    • Akershus University Hospital
  • Oslo, Norway
    • Oslo University Hospital
  • Oslo, Norway, 0316
    • University of Oslo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• colorectal cancer (ICD10 C18-20) TNM Stage I-III

Exclusion Criteria:

• TNM stage 0 or IV

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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.	Other: Norwegian food based dietary guidelines; 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; Other Names: Typisk norsk
Other: Control group; The control group (n = 250) receives no dietary intervention other than standard clinical care. Both groups are offered equal general advice of physical activity.	Other: Norwegian food based dietary guidelines; 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; Other Names: Typisk norsk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Oslo
• Collaborators: Oslo University Hospital; The Research Council of Norway; University Hospital, Akershus; Finnish Institute for Health and Welfare; Norwegian Cancer Society
• Investigators: Principal Investigator: Rune Blomhoff, Professor, University of Oslo

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• Eklo RR, Alavi DT, Konglevoll DM, Kolle A, Henriksen HB, Rising R, Blomhoff R, Olsen T. Predictive equations commonly used in clinics underestimate resting energy expenditure compared with whole-room indirect calorimetry in colorectal cancer survivors. Am J Clin Nutr. 2026 Jan 27:101209. doi: 10.1016/j.ajcnut.2026.101209. Online ahead of print.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2012
• Primary Completion (Estimated): December 31, 2034
• Study Completion (Estimated): December 31, 2040

Study Registration Dates

• First Submitted: March 22, 2012
• First Submitted That Met QC Criteria: March 30, 2012
• First Posted (Estimated): April 4, 2012

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CRC-NORDIET study; 2011/836 (Other Identifier: REK Sør-Øst)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No