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 |
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Recruitment Status :
Recruiting
First Posted : April 4, 2012
Last Update Posted : December 7, 2015
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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
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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 |
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
| 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 |
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Control group
Counseling on physical activity only
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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 :
- 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
- 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
- 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
- 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
- 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 :
- 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
- colorectal cancer-free survival and disease-free survival [ Time Frame: up to 15 years ]
- Fatigue and quality of life [ Time Frame: 0, 0.5, 1, 3, 5, 7, 10 and 15 years ]Questionnaires
- Biomarkers of thromboembolic disease [ Time Frame: 0, 0.5, 1, 3, 5, 7, 10 and 15 years ]
- 25 hydroxy vitamin D [ Time Frame: 0, 0.5, 1, 3, 5, 7, 10 and 15 years ]
- whole genome transcription profiles and methylation patterns [ Time Frame: 0, 0.5, 1, 3, 5, 7, 10 and 15 years ]
- 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
- 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
- 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
- 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
- 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
- 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 50 Years to 75 Years (Adult, Older Adult) |
| 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:
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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 |