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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 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

March 22, 2012
December 4, 2015
March 2012
March 2040   (final data collection date for primary outcome measure)
  • Change in biomarkers of comorbid conditions over the intervention period [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Submaximal oxygen test, grip strenght and physical activity level
  • Change in dietary patterns during first 12 months [ Time Frame: 0, 6 ,and 12 months ] [ Designated as safety issue: No ]
    Questionnaires, biomarkers of dietary intake and food diaries
Same as current
Complete list of historical versions of study NCT01570010 on ClinicalTrials.gov Archive Site
  • Mortality [ Time Frame: up to 15 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Fatigue and quality of life [ Time Frame: 0, 0.5, 1, 3, 5, 7, 10 and 15 years ] [ Designated as safety issue: No ]
    Questionnaires
  • Biomarkers of thromboembolic disease [ Time Frame: 0, 0.5, 1, 3, 5, 7, 10 and 15 years ] [ Designated as safety issue: No ]
  • 25 hydroxy vitamin D [ Time Frame: 0, 0.5, 1, 3, 5, 7, 10 and 15 years ] [ Designated as safety issue: No ]
  • whole genome transcription profiles and methylation patterns [ Time Frame: 0, 0.5, 1, 3, 5, 7, 10 and 15 years ] [ Designated as safety issue: No ]
  • Co-morbidity [ Time Frame: 0.5, 1, 3, 5, 7, 10, 15 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Questionnaires, biomarkers of dietary intake and food diaries
Same as current
Not Provided
Not Provided
 
Effect of the New Norwegian Food Based Dietary Guidelines on Chronic Diseases in Colorectal Cancer Survivors
Effect of the New Norwegian Food Based Dietary Guidelines on Chronic Diseases in Colorectal Cancer Survivors
The aim of this study to examine whether an intensive dietary intervention affects health measures and development of lifestyle diseases in colorectal cancer survivors.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Colorectal Cancer
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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
March 2040
March 2040   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • TNM stage 0 or IV
Both
50 Years to 75 Years   (Adult, Senior)
No
Contact: Rune Blomhoff, PhD +4722851395 rune.blomhoff@medisin.uio.no
Norway
 
NCT01570010
Norwegian Foods Study, 2011/836
Yes
Not Provided
Not Provided
Rune Blomhoff, University of Oslo
University of Oslo
  • 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
Principal Investigator: Rune Blomhoff, Professor University of Oslo
University of Oslo
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP