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

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ClinicalTrials.gov Identifier: NCT01570010
Recruitment Status : Recruiting
First Posted : April 4, 2012
Last Update Posted : December 7, 2015
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

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: new norwegian food based dietary guidelines Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of the New Norwegian Food Based Dietary Guidelines on Chronic Diseases in Colorectal Cancer Survivors
Study Start Date : March 2012
Estimated Primary Completion Date : March 2040
Estimated Study Completion Date : March 2040

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intervention group 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
Control group
Counseling on physical activity only
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



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Change in dietary patterns during first 12 months [ Time Frame: 0, 6 ,and 12 months ]
    Questionnaires, biomarkers of dietary intake and food diaries


Secondary Outcome Measures :
  1. 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

  2. colorectal cancer-free survival and disease-free survival [ Time Frame: up to 15 years ]
  3. Fatigue and quality of life [ Time Frame: 0, 0.5, 1, 3, 5, 7, 10 and 15 years ]
    Questionnaires

  4. Biomarkers of thromboembolic disease [ Time Frame: 0, 0.5, 1, 3, 5, 7, 10 and 15 years ]
  5. 25 hydroxy vitamin D [ Time Frame: 0, 0.5, 1, 3, 5, 7, 10 and 15 years ]
  6. whole genome transcription profiles and methylation patterns [ Time Frame: 0, 0.5, 1, 3, 5, 7, 10 and 15 years ]
  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • TNM stage 0 or IV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01570010


Contacts
Contact: Rune Blomhoff, PhD +4722851395 rune.blomhoff@medisin.uio.no

Locations
Norway
Vestre Viken Hospital Not yet recruiting
Sandvika, Akershus, Norway
Contact: Rune Blomhoff, Proff         
Vestre Viken HF Not yet recruiting
Drammen, Buskerud, Norway
Contact: Rune Blomhoff, Prof.         
Akershus University Hospital Not yet recruiting
Lørenskog, Norway, 1478
Principal Investigator: Færden, MD         
University of Oslo Not yet recruiting
Oslo, Norway, 0316
Principal Investigator: Rune Blomhoff, PhD         
Oslo University Hospital Recruiting
Oslo, Norway
Principal Investigator: Smeland, MD         
Sponsors and Collaborators
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
Investigators
Principal Investigator: Rune Blomhoff, Professor University of Oslo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rune Blomhoff, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT01570010     History of Changes
Other Study ID Numbers: Norwegian Foods Study
2011/836 ( Other Identifier: REK Sør-Øst )
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Colorectal Neoplasms
Chronic Disease
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Disease Attributes
Pathologic Processes