- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01570010
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
Intervention / Treatment
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:
|
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:
|
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.
Sponsor
Collaborators
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
- 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.
- 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.
- 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.
- 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.
- 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.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRC-NORDIET study
- 2011/836 (Other Identifier: REK Sør-Øst)
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.
Clinical Trials on Colorectal Cancer
-
University of California, San FranciscoCompletedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedRectal Cancer | Colon Cancer | Cancer Survivor | Colorectal Adenocarcinoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
M.D. Anderson Cancer CenterRecruitingColorectal Adenocarcinoma | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedCancer Survivor | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal Cancer AJCC v8 | Stage IIB Colorectal... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...United States Department of DefenseActive, not recruitingColorectal Adenoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage 0 Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal... and other conditionsUnited States
-
University of Roma La SapienzaCompletedColorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Cancer Stage 0 | Colorectal Cancer Stage IItaly
-
University of Southern CaliforniaNational Cancer Institute (NCI); AmgenTerminatedStage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Colorectal Adenocarcinoma | RAS Wild Type | Stage III Colorectal Cancer AJCC v7 | Stage IIIA Colorectal Cancer AJCC v7 | Stage IIIB Colorectal Cancer AJCC v7 | Stage IIIC Colorectal Cancer...United States
-
Emory UniversityBristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of...Active, not recruitingColorectal Cancer Metastatic | Colorectal Adenocarcinoma | Stage IV Colorectal Cancer | Stage IVA Colorectal Cancer | Stage IVB Colorectal Cancer | Refractory Colorectal Carcinoma | Metastatic Microsatellite Stable Colorectal Carcinoma | Stage IVC Colorectal CancerUnited States
Clinical Trials on Norwegian food based dietary guidelines
-
Ethiopian Public Health InstituteWageningen University; International Food Policy Research Institute; Food and...Completed
-
Indonesia UniversityNestlé FoundationUnknownChild Development | Nutritional AnemiaIndonesia
-
Indiana UniversityCompletedSarcoma | Acute Lymphoblastic Leukemia | Acute Myelogenous Leukemia | Neuroblastoma | Non-Hodgkins LymphomaUnited States
-
University College DublinQueen's University, Belfast; University College Cork; TeagascCompletedDietary Habits | Healthy Diet | Healthy Nutrition | Personalized NutritionIreland, United Kingdom
-
University of TorontoWomen's College HospitalCompleted
-
Pennington Biomedical Research CenterCompleted
-
Rabin Medical CenterUnknown
-
Medtronic Cardiac Rhythm and Heart FailureCompletedSinus Node DysfunctionPeru, Bangladesh, India, Mexico, Argentina, Russian Federation, Uruguay
-
Uplifting Results Labs Inc.CompletedDiabetes Mellitus, Type 2United States
-
Queen's University, BelfastCompletedBlood PressureUnited Kingdom