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

• 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
  
  

• 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
  
  

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.