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NCT Number: NCT01570010

The Norwegian Dietary Guidelines and Colorectal Cancer Survival Study

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akershus University Hospital, Lørenskog, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • TNM stage 0 or IV

Treatment and study plan

Norwegian food based dietary guidelines

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

Other names: Typisk norsk

Primary outcomes

  1. Disease-free survival

    Time frame: 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)

  2. Overall survival

    Time frame: 5, 10 and 15 years

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

Secondary outcomes

  1. Time to recurrence

    Time frame: up to 15 years

    Events are defined as detection of local recurrence or metastasis

  2. CVD -free survival

    Time frame: up to 15 years

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

  3. CRC-specific survival

    Time frame: up to 15 years

    death due to CRC

  4. Total cancer-specific survival

    Time frame: up to 15 years

    death due to CRC or any other cancer

  5. Inflammatory disease-specific survival

    Time frame: up to 15 years

    death due to inflammatory disease

  6. Cardiovascular (CVD)-specific survival

    Time frame: up to 15 years

    death due to CVD

  7. New morbidity of other diet-related chronic diseases

    Time frame: up to 15 years

    e.g. ischemic coronary heart disease, cerebrovascular disease, thromboembolic disease, type 2 diabetes, obesity, hypertension and chronic obstructive pulmonary disease

  8. Dietary intake and nutritional status

    Time frame: up to 15 years

    Questionnaires, food records, clinical consultation

  9. Physical activity and function

    Time frame: up to 15 years

    Questionnaires, arm band, physical tests

  10. Nutrition biomarkers

    Time frame: up to 15 years

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

  11. Body composition

    Time frame: up to 15 years

    DXA, CT, BIA

  12. Anthropometric measures

    Time frame: up to 15 years

    eg weight, waist and hip circumference

  13. Biomarkers for inflammation and oxidative stress

    Time frame: up to 15 years

    e.g. isoprostanes, cytokines

  14. Transcription- and epigenetic profiles

    Time frame: up to 15 years

    sequencing and arrays

  15. Biomarkers for cardiovascular disease, metabolic syndrome, type 2-diabetes, thromboembolic disease and cancer

    Time frame: up to 15 years

    e.g. blood pressure, total/LDLcholesterol, HbA1c, CRP, IL-6, IL-10, TNFα

  16. Health related quality of life and fatigue

    Time frame: up to 15 years

    Questionnaires

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Finnish Institute for Health and Welfare
  • Norwegian Cancer Society
  • Oslo University Hospital
  • The Research Council of Norway
  • University Hospital, Akershus

Registry information

Official study title

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

Acronym: CRC-NORDIET

Important dates

Study start
2012
Primary completion
2034
Study completion
2040
First posted
Apr 4, 2012
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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