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

This study is currently recruiting participants.

See

Contacts and Locations

Verified December 2015 by Rune Blomhoff, University of Oslo

Sponsor:

Collaborators:

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

Information provided by (Responsible Party):

Rune Blomhoff, University of Oslo

ClinicalTrials.gov Identifier:

NCT01570010

First received: March 22, 2012

Last updated: December 4, 2015

Last verified: December 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

March 22, 2012

Last Updated Date

December 4, 2015

Start Date ^ICMJE

March 2012

Estimated Primary Completion Date

March 2040 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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 Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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, 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

500

Estimated 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

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

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