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Colorectal CancerCRC-NORDIETNCT01570010

The Norwegian Dietary Guidelines and Colorectal Cancer Survival Study

A study testing Norwegian food based dietary guidelines in people with Colorectal Cancer, run by University of Oslo at 3 sites in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Colorectal Cancer
What is being tested?
Norwegian food based dietary guidelines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
503 participants
Where
3 sitesNorway
Study dates
1 Mar 2012to 31 Dec 2040
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • TNM stage 0 or IV

Trial locations and contacts

3 sites in 1 country.

Norway3 sites

  • Akershus University Hospital

    Lørenskog, 1478

  • University of Oslo

    Oslo, 0316

  • Oslo University Hospital

    Oslo

Other trials in Norway

About this study

Official title: 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.

Read the 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.

Being tested
Norwegian food based dietary guidelines
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Norwegian food based dietary guidelinesOther

    Also called Typisk norsk

    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

Study groups in NCT01570010
Study groupRoleWhat they receive
Intervention groupExperimentalThe 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.
Receives: Other: Norwegian food based dietary guidelines
Control groupOtherThe control group (n = 250) receives no dietary intervention other than standard clinical care. Both groups are offered equal general advice of physical activity.
Receives: Other: Norwegian food based dietary guidelines

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 5, 10 and 15 years

  2. Overall survival

    Overall survival (OS) (event is defined as death from any cause)

    Measured: 5, 10 and 15 years

Secondary outcomes (16)

  1. Time to recurrence

    Events are defined as detection of local recurrence or metastasis

    Measured: up to 15 years

  2. CVD -free survival

    Events of CVD (ICD-10; chapter I) or death from any cause

    Measured: up to 15 years

  3. CRC-specific survival

    death due to CRC

    Measured: up to 15 years

  4. Total cancer-specific survival

    death due to CRC or any other cancer

    Measured: up to 15 years

  5. Inflammatory disease-specific survival

    death due to inflammatory disease

    Measured: up to 15 years

  6. Cardiovascular (CVD)-specific survival

    death due to CVD

    Measured: up to 15 years

  7. 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

    Measured: up to 15 years

  8. Dietary intake and nutritional status

    Questionnaires, food records, clinical consultation

    Measured: up to 15 years

  9. Physical activity and function

    Questionnaires, arm band, physical tests

    Measured: up to 15 years

  10. Nutrition biomarkers

    e.g., carotenoids, fatty acids, 25-hydroxy vitamin D etc

    Measured: up to 15 years

  11. Body composition

    DXA, CT, BIA

    Measured: up to 15 years

  12. Anthropometric measures

    eg weight, waist and hip circumference

    Measured: up to 15 years

  13. Biomarkers for inflammation and oxidative stress

    e.g. isoprostanes, cytokines

    Measured: up to 15 years

  14. Transcription- and epigenetic profiles

    sequencing and arrays

    Measured: up to 15 years

  15. 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

    Measured: up to 15 years

  16. Health related quality of life and fatigue

    Questionnaires

    Measured: up to 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2012 (estimated)
  2. Study start1 Mar 2012
  3. Primary completion31 Dec 2034 (estimated)
  4. Study completion31 Dec 2040 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel randomized clinical trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
503 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01570010
Sponsor's protocol ID
CRC-NORDIET study
Other IDs
2011/836
Acronym
CRC-NORDIET
Status last verified
Jun 2026
First submitted
22 Mar 2012
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 28137255

  • 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.

    PubMed 34999327

  • 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.

    PubMed 34024541

  • 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.

    PubMed 29854408

  • 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.

    PubMed 29545734

  • 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.

    PubMed 41611086

  • 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.

    PubMed 40346639

  • 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.

    PubMed 40180023

  • 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.

    PubMed 37739688

Questions about this trial

What is this clinical trial studying?

A study testing Norwegian food based dietary guidelines in people with Colorectal Cancer, run by University of Oslo at 3 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (time frame: 5, 10 and 15 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01570010, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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