Effect of the New Norwegian Food Based Dietary Guidelines on Chronic Diseases in Colorectal Cancer Survivors (NFS)

Tracking Information
First Submitted Date ICMJE	March 22, 2012
First Posted Date ICMJE	April 4, 2012
Last Update Posted Date	December 7, 2015
Study Start Date ICMJE	March 2012
Estimated Primary Completion Date	March 2040 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 30, 2012)	Change in biomarkers of comorbid conditions over the intervention period [ Time Frame: 0, 6 and 12 months ]Including but not limited to: blood pressure, LDL-/HDL-/VLDL-/oxLDL-/totalcholesterol, cholesterol efflux, triglyserides, HbA1c, blood sugar, BMI, body composition, waist and hip circumference, CEA; Change in biomarkers of inflammation and oxidative stress from baseline to 6 and 12 months [ Time Frame: 0, 6 and 12 months ]Including but not limited to: CRP, interleukines/chemokines, isoprostanes, GSH:GSSG, FRAP, dROM; Compliance to intervention up to 12 months [ Time Frame: 0, 6, and 12 months ]Compliance to the intervention tested via biomarkers in blood such as carotenoids and fatty acids profiles, and via self reporting in questionnaires; Change in physical function over the first 12 months [ Time Frame: 0, 6, and 12 months ]Submaximal oxygen test, grip strenght and physical activity level; Change in dietary patterns during first 12 months [ Time Frame: 0, 6 ,and 12 months ]Questionnaires, biomarkers of dietary intake and food diaries
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01570010 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: March 30, 2012)	Mortality [ Time Frame: up to 15 years ]All-cause mortality, diet-related chronic diseases (a priori defined), deaths attributed to cardiovascular diseases, cancers and non CVD-, non-cancer-, inflammatory diseases; colorectal cancer-free survival and disease-free survival [ Time Frame: up to 15 years ]; Fatigue and quality of life [ Time Frame: 0, 0.5, 1, 3, 5, 7, 10 and 15 years ]Questionnaires; Biomarkers of thromboembolic disease [ Time Frame: 0, 0.5, 1, 3, 5, 7, 10 and 15 years ]; 25 hydroxy vitamin D [ Time Frame: 0, 0.5, 1, 3, 5, 7, 10 and 15 years ]; whole genome transcription profiles and methylation patterns [ Time Frame: 0, 0.5, 1, 3, 5, 7, 10 and 15 years ]; Co-morbidity [ Time Frame: 0.5, 1, 3, 5, 7, 10, 15 years ]Including but not limited to cardiovascular diseases, diabetes, recurring cancer, incident cancers, etc; Change in biomarkers of comorbid conditions compared to baseline [ Time Frame: 3, 5, 7, 10 and 15 years ]Including but not limited to: blood pressure, LDL-/HDL-/VLDL-/oxLDL-/totalcholesterol, cholesterol efflux, triglyserides, HbA1c, blood sugar, BMI, body composition, waist and hip circumference, CEA; Change in biomarkers of inflammation and oxidative stress [ Time Frame: 0, 3, 5, 7, 10 and 15 years ]Including but not limited to: CRP, interleukines/chemokines, isoprostanes, GSH:GSSG, FRAP, dROM; Continued ompliance to intervention during follow up [ Time Frame: up to 15 years ]Compliance to the intervention tested via biomarkers in blood such as carotenoids and fatty acids profiles, and via self reporting in questionnaires; Change in physical function up to 15 years [ Time Frame: 0, 3, 5, 7, 10 and 15 years ]Submaximal oxygen test, grip strenght and physical activity level; Change in dietary patterns up to 15 years [ Time Frame: 0, 3, 5, 7, 10 and 15 years ]Questionnaires, biomarkers of dietary intake and food diaries
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effect of the New Norwegian Food Based Dietary Guidelines on Chronic Diseases in Colorectal Cancer Survivors
Official Title ICMJE	Effect of the New Norwegian Food Based Dietary Guidelines on Chronic Diseases in Colorectal Cancer Survivors
Brief Summary	The aim of this study to examine whether an intensive dietary intervention affects health measures and development of lifestyle diseases in colorectal cancer survivors.
Detailed Description	The increased incidence and survival after treatment contributes to a rising number of people living with a previous cancer diagnosis. Cancer-survivors have an increased risk of developing other lifestyle diseases compared to an age-mathed general population. The aim of this study to examine whether a dietary changes affects health and development of lifestyle diseases after treatment for colorectal cancer. The diet in the study is based on the new Norwegian food-based dietary guidelines, and in addition focus is placed on foods which have been shown to inhibit inflammation or oxidative stress in epidemiological and experimental studies, as well as Norwegian and Nordic foods. The dietary intervention is combined with intensive follow-up to ensure high compliance to the diet.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
Condition ICMJE	Colorectal Cancer
Intervention ICMJE	Other: new 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
Study Arms	Experimental: Intervention group Intervention: Other: new norwegian food based dietary guidelines; Control group Counseling on physical activity only Intervention: Other: new norwegian food based dietary guidelines
Publications *	Henriksen HB, Carlsen MH, Paur I, Berntsen S, Bøhn SK, Skjetne AJ, Kværner 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.; 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. 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: March 30, 2012)	500
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	March 2040
Estimated Primary Completion Date	March 2040 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: colorectal cancer (ICD10 C18-20) TNM Stage I-III Exclusion Criteria: TNM stage 0 or IV
Sex/Gender	Sexes Eligible for Study: All
Ages	50 Years to 75 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Rune Blomhoff, PhD +4722851395 rune.blomhoff@medisin.uio.no
Listed Location Countries ICMJE	Norway
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01570010
Other Study ID Numbers ICMJE	Norwegian Foods Study; 2011/836 ( Other Identifier: REK Sør-Øst )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Rune Blomhoff, University of Oslo
Study Sponsor ICMJE	University of Oslo
Collaborators ICMJE	Oslo University Hospital; National Institute for Health and Welfare, Finland; University Hospital, Akershus; Asker & Baerum Hospital; Sykehuset Buskerud HF; Norwegian Cancer Society; The Research Council of Norway
Investigators ICMJE	Principal Investigator: Rune Blomhoff, Professor University of Oslo
PRS Account	University of Oslo
Verification Date	December 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP