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
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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
Tracking Information | |||||
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First Submitted Date ICMJE | March 22, 2012 | ||||
First Posted Date ICMJE | April 4, 2012 | ||||
Last Update Posted Date | December 7, 2015 | ||||
Study Start Date ICMJE | March 2012 | ||||
Estimated Primary Completion Date | March 2040 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01570010 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Effect of the New Norwegian Food Based Dietary Guidelines on Chronic Diseases in Colorectal Cancer Survivors | ||||
Official Title ICMJE | Effect of the New Norwegian Food Based Dietary Guidelines on Chronic Diseases in Colorectal Cancer Survivors | ||||
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. | ||||
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 ICMJE | Interventional | ||||
Study Phase | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE | Colorectal Cancer | ||||
Intervention ICMJE | 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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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
500 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date | March 2040 | ||||
Estimated Primary Completion Date | March 2040 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 50 Years to 75 Years (Adult, Senior) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Norway | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01570010 | ||||
Other Study ID Numbers ICMJE | Norwegian Foods Study 2011/836 ( Other Identifier: REK Sør-Øst ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement | Not Provided | ||||
Responsible Party | Rune Blomhoff, University of Oslo | ||||
Study Sponsor ICMJE | University of Oslo | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Oslo | ||||
Verification Date | December 2015 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |