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:
University of Oslo
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
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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 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
|
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 (Adult, Senior) |
| 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
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 | |
| 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 |
More Information
| 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: | December 4, 2015 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics |
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 |
ClinicalTrials.gov processed this record on September 23, 2016