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Effect of Norwegian Food Based Dietary Guidelines on Chronic Diseases in CRC Survivors (CRC-NORDIET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01570010
Recruitment Status : Active, not recruiting
First Posted : April 4, 2012
Last Update Posted : March 28, 2022
Sponsor:
Collaborators:
Oslo University Hospital
Finnish Institute for Health and Welfare
University Hospital, Akershus
Norwegian Cancer Society
The Research Council of Norway
Information provided by (Responsible Party):
Rune Blomhoff, University of Oslo

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: Norwegian food based dietary guidelines Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 503 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel randomized clinical trial
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Norwegian Dietary Guidelines and Colorectal Cancer Survival Study
Actual Study Start Date : March 1, 2012
Estimated Primary Completion Date : December 31, 2034
Estimated Study Completion Date : December 31, 2040

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: 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
Other Name: Typisk norsk

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.
Other: 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
Other Name: Typisk norsk




Primary Outcome Measures :
  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: 10, 15 years ]
    Overall survival (OS) (event is defined as death from any cause)


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • TNM stage 0 or IV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01570010


Locations
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Norway
Akershus University Hospital
Lørenskog, Norway, 1478
University of Oslo
Oslo, Norway, 0316
Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
University of Oslo
Oslo University Hospital
Finnish Institute for Health and Welfare
University Hospital, Akershus
Norwegian Cancer Society
The Research Council of Norway
Investigators
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Principal Investigator: Rune Blomhoff, Professor University of Oslo
Publications of Results:

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Responsible Party: Rune Blomhoff, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT01570010    
Other Study ID Numbers: CRC-NORDIET study
2011/836 ( Other Identifier: REK Sør-Øst )
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: March 28, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases