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

March 11, 2022 updated by: Rune Blomhoff, University of Oslo

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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

503

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lørenskog, Norway, 1478
        • Akershus University Hospital
      • Oslo, Norway
        • Oslo University Hospital
      • Oslo, Norway, 0316
        • University of Oslo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • TNM stage 0 or IV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.
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
Other: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
5, 10 and 15 years
Overall survival
Time Frame: 10, 15 years
Overall survival (OS) (event is defined as death from any cause)
10, 15 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to recurrence
Time Frame: up to 15 years
Events are defined as detection of local recurrence or metastasis
up to 15 years
CVD -free survival
Time Frame: up to 15 years
Events of CVD (ICD-10; chapter I) or death from any cause
up to 15 years
CRC-specific survival
Time Frame: up to 15 years
death due to CRC
up to 15 years
Total cancer-specific survival
Time Frame: up to 15 years
death due to CRC or any other cancer
up to 15 years
Inflammatory disease-specific survival
Time Frame: up to 15 years
death due to inflammatory disease
up to 15 years
Cardiovascular (CVD)-specific survival
Time Frame: up to 15 years
death due to CVD
up to 15 years
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
up to 15 years
Dietary intake and nutritional status
Time Frame: up to 15 years
Questionnaires, food records, clinical consultation
up to 15 years
Physical activity and function
Time Frame: up to 15 years
Questionnaires, arm band, physical tests
up to 15 years
Nutrition biomarkers
Time Frame: up to 15 years
e.g., carotenoids, fatty acids, 25-hydroxy vitamin D etc
up to 15 years
Body composition
Time Frame: up to 15 years
DXA, CT, BIA
up to 15 years
Anthropometric measures
Time Frame: up to 15 years
eg weight, waist and hip circumference
up to 15 years
Biomarkers for inflammation and oxidative stress
Time Frame: up to 15 years
e.g. isoprostanes, cytokines
up to 15 years
Transcription- and epigenetic profiles
Time Frame: up to 15 years
sequencing and arrays
up to 15 years
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
up to 15 years
Health related quality of life and fatigue
Time Frame: up to 15 years
Questionnaires
up to 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rune Blomhoff, Professor, University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2012

Primary Completion (Anticipated)

December 31, 2034

Study Completion (Anticipated)

December 31, 2040

Study Registration Dates

First Submitted

March 22, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (Estimate)

April 4, 2012

Study Record Updates

Last Update Posted (Actual)

March 28, 2022

Last Update Submitted That Met QC Criteria

March 11, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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