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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 May 2014 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: May 2, 2014
Last verified: May 2014
  Purpose

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 Intervention
Colorectal Cancer
Other: new norwegian food based dietary guidelines

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effect of the New Norwegian Food Based Dietary Guidelines on Chronic Diseases in Colorectal Cancer Survivors

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 500
Study Start Date: March 2012
Estimated Study Completion Date: March 2040
Estimated Primary Completion Date: March 2040 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Names:
  • Typisk norsk
  • New Norwegian food based dietary guidelines
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 Names:
  • Typisk norsk
  • New Norwegian food based dietary guidelines

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • TNM stage 0 or IV
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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         
Oslo University Hospital Recruiting
Oslo, Norway
Principal Investigator: Smeland, MD         
University of Oslo Not yet recruiting
Oslo, Norway, 0316
Principal Investigator: Rune Blomhoff, PhD         
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
  More Information

No publications provided

Responsible Party: Rune Blomhoff, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT01570010     History of Changes
Other Study ID Numbers: Norwegian Foods Study, 2011/836
Study First Received: March 22, 2012
Last Updated: May 2, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

ClinicalTrials.gov processed this record on November 25, 2014