NCT01570010

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
503

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
178mo left

Started Mar 2012

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Mar 2012Dec 2040

Study Start

First participant enrolled

March 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 4, 2012

Completed
22.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2034

Expected
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2040

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

22.8 years

First QC Date

March 22, 2012

Last Update Submit

February 25, 2026

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (16)

  • Time to recurrence

    up to 15 years

  • CVD -free survival

    up to 15 years

  • CRC-specific survival

    up to 15 years

  • Total cancer-specific survival

    up to 15 years

  • Inflammatory disease-specific survival

    up to 15 years

  • +11 more secondary outcomes

Study Arms (2)

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.

Other: Norwegian food based dietary guidelines

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.

Other: Norwegian food based dietary guidelines

Interventions

Norwegian food based dietary guidelinesOTHER

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

Also known as: Typisk norsk
Control groupIntervention group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • TNM stage 0 or IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Akershus University Hospital

Lørenskog, 1478, Norway

Location

University of Oslo

Oslo, 0316, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

Related Publications (9)

  • 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.

    PMID: 28137255RESULT

  • 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.

    PMID: 34999327RESULT

  • 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.

    PMID: 34024541RESULT

  • 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.

    PMID: 29854408RESULT

  • 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.

    PMID: 29545734RESULT

  • 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.

    PMID: 41611086DERIVED

  • 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.

    PMID: 40346639DERIVED

  • 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.

    PMID: 40180023DERIVED

  • 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.

    PMID: 37739688DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Rune Blomhoff, Professor

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Parallel randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 22, 2012

First Posted

April 4, 2012

Study Start

March 1, 2012

Primary Completion (Estimated)

December 31, 2034

Study Completion (Estimated)

December 31, 2040

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

NO(3)