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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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 Design

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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

Arms and Interventions

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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
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

Outcome Measures

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Primary Outcome Measures :

1. 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
2. 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
3. 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
4. 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
5. 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 :

1. 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
2. colorectal cancer-free survival and disease-free survival [ Time Frame: up to 15 years ]
3. Fatigue and quality of life [ Time Frame: 0, 0.5, 1, 3, 5, 7, 10 and 15 years ]
   Questionnaires
4. Biomarkers of thromboembolic disease [ Time Frame: 0, 0.5, 1, 3, 5, 7, 10 and 15 years ]
5. 25 hydroxy vitamin D [ Time Frame: 0, 0.5, 1, 3, 5, 7, 10 and 15 years ]
6. whole genome transcription profiles and methylation patterns [ Time Frame: 0, 0.5, 1, 3, 5, 7, 10 and 15 years ]
7. 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
8. 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
9. 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
10. 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
11. 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
12. 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

Eligibility Criteria

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Ages Eligible for Study:	50 Years to 75 Years (Adult, Senior)
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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Henriksen HB, Carlsen MH, Paur I, Berntsen S, Bøhn SK, Skjetne AJ, Kværner AS, Henriksen C, Andersen LF, Smeland S, Blomhoff R. Relative validity of a short food frequency questionnaire assessing adherence to the Norwegian dietary guidelines among colorectal cancer patients. Food Nutr Res. 2018 Feb 22;62. doi: 10.29219/fnr.v62.1306. eCollection 2018.

Henriksen HB, Ræder H, Bøhn SK, Paur I, Kværner AS, Billington SÅ, Eriksen MT, Wiedsvang G, Erlund I, Færden A, Veierød MB, Zucknick M, Smeland S, Blomhoff R. The Norwegian dietary guidelines and colorectal cancer survival (CRC-NORDIET) study: a food-based multicentre randomized controlled trial. BMC Cancer. 2017 Jan 30;17(1):83. doi: 10.1186/s12885-017-3072-4.

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
Last Update Posted:	December 7, 2015
Last Verified:	December 2015

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