Effect of Norwegian Food Based Dietary Guidelines on Chronic Diseases in CRC Survivors

NCT ID: NCT01570010

Last Updated: 2022-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

503 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-01

Study Completion Date

2040-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel randomized clinical trial
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Norwegian food based dietary guidelines

Intervention Type 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

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.

Group Type OTHER

Norwegian food based dietary guidelines

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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Typisk norsk

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* TNM stage 0 or IV
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

Finnish Institute for Health and Welfare

OTHER_GOV

Sponsor Role collaborator

University Hospital, Akershus

OTHER

Sponsor Role collaborator

Norwegian Cancer Society

OTHER

Sponsor Role collaborator

The Research Council of Norway

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role lead

Responsible Party

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Rune Blomhoff

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rune Blomhoff, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Locations

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Akershus University Hospital

Lørenskog, , Norway

Site Status

University of Oslo

Oslo, , Norway

Site Status

Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 28137255 (View on PubMed)

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.

Reference Type RESULT
PMID: 34999327 (View on PubMed)

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.

Reference Type RESULT
PMID: 34024541 (View on PubMed)

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.

Reference Type RESULT
PMID: 29854408 (View on PubMed)

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.

Reference Type RESULT
PMID: 29545734 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40346639 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40180023 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37739688 (View on PubMed)

Other Identifiers

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2011/836

Identifier Type: OTHER

Identifier Source: secondary_id

CRC-NORDIET study

Identifier Type: -

Identifier Source: org_study_id

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