The Norwegian Dietary Guidelines and Colorectal Cancer Survival Study

Conditions

Colorectal Cancer

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.

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.

Rakel R. Eklo, Dena T. Alavi, Dina M. Konglevoll, Åshild Kolle, Hege B. Henriksen et al. (8 authors)

American Journal of Clinical Nutrition2026-01-01

10.1016/j.ajcnut.2026.101209

Spillover effect of a dietary intervention on physical activity in a randomized controlled trial with colorectal cancer patients

Hege Berg Henriksen, Åshild Kolle, Andreas Stenling, Ingvild Paur, Siv Kjølsrud Bøhn et al. (9 authors)

International Journal of Behavioral Nutrition and Physical Activity2025-05-09

10.1186/s12966-025-01757-0

Plant-based diet and oxidative stress-induced DNA damage in post-surgery colorectal cancer patients: Results from a randomized controlled trial.

Nordengen AL, Krutto A, Kværner AS, Alavi DT, Henriksen HB, Kolle Å, Henriksen C, Smeland S, Bøhn SK, Zheng C, Shaposhnikov S, Collins AR, Blomhoff R.

2025-04-011 citations

10.1016/j.freeradbiomed.2025.03.047

Validation of two short questionnaires assessing physical activity in colorectal cancer patients.

Henriksen HB, Berntsen S, Paur I, Zucknick M, Skjetne AJ, Bøhn SK, Henriksen C, Smeland S, Carlsen MH, Blomhoff R.

2018-05-2911 citations

10.1186/s13102-018-0096-2

Relative validity of a short food frequency questionnaire assessing adherence to the Norwegian dietary guidelines among colorectal cancer patients

Hege Berg Henriksen, Monica Hauger Carlsen, Ingvild Paur, Sveinung Berntsen, Siv Kjølsrud Bøhn et al. (11 authors)

Food & Nutrition Research2018-02-2232 citations

10.29219/fnr.v62.1306

The Norwegian dietary guidelines and colorectal cancer survival (CRC-NORDIET) study: a food-based multicentre randomized controlled trial.

Henriksen HB, Ræder H, Bøhn SK, Paur I, Kværner AS, Billington SÅ, Eriksen MT, Wiedsvang G, Erlund I, Færden A, Veierød MB, Zucknick M, Smeland S, Blomhoff R.

2017-01-3026 citations

10.1186/s12885-017-3072-4

Interventions

OTHERNorwegian 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

Parallel randomized clinical trial

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

No

Inclusion criteria

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

Exclusion criteria

* TNM stage 0 or IV

Design outcomes

Primary

Measure	Time frame	Description
Disease-free survival	5, 10 and 15 years	Disease-free survival (DFS) (events are defined as detection of local recurrence or metastasis or any second cancer or death from any cause)
Overall survival	5, 10 and 15 years	Overall survival (OS) (event is defined as death from any cause)

Secondary

Measure	Time frame	Description
Time to recurrence	up to 15 years	Events are defined as detection of local recurrence or metastasis
CVD -free survival	up to 15 years	Events of CVD (ICD-10; chapter I) or death from any cause
CRC-specific survival	up to 15 years	death due to CRC
Total cancer-specific survival	up to 15 years	death due to CRC or any other cancer
Inflammatory disease-specific survival	up to 15 years	death due to inflammatory disease
Cardiovascular (CVD)-specific survival	up to 15 years	death due to CVD
New morbidity of other diet-related chronic diseases	up to 15 years	e.g. ischemic coronary heart disease, cerebrovascular disease, thromboembolic disease, type 2 diabetes, obesity, hypertension and chronic obstructive pulmonary disease
Dietary intake and nutritional status	up to 15 years	Questionnaires, food records, clinical consultation
Physical activity and function	up to 15 years	Questionnaires, arm band, physical tests
Nutrition biomarkers	up to 15 years	e.g., carotenoids, fatty acids, 25-hydroxy vitamin D etc
Body composition	up to 15 years	DXA, CT, BIA
Anthropometric measures	up to 15 years	eg weight, waist and hip circumference
Biomarkers for inflammation and oxidative stress	up to 15 years	e.g. isoprostanes, cytokines
Transcription- and epigenetic profiles	up to 15 years	sequencing and arrays
Biomarkers for cardiovascular disease, metabolic syndrome, type 2-diabetes, thromboembolic disease and cancer	up to 15 years	e.g. blood pressure, total/LDLcholesterol, HbA1c, CRP, IL-6, IL-10, TNFα
Health related quality of life and fatigue	up to 15 years	Questionnaires

Countries

Norway

Contacts

PRINCIPAL_INVESTIGATORRune Blomhoff, Professor

University of Oslo

Outcome results

None listed