Compliance to the Norwegian Food-Based Dietary Guidelines in Young Females

Study Overview
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Brief Summary
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The Norwegian Directorate of Health recently published the Norwegian food-based dietary guidelines (NFBDG) in 2011. The target for the NFBDG is the general population, and the main aims of these guidelines are to promote public health and prevent chronic degenerative diseases. Reaching the healthy population is crucial as only small proportion of the general population comply to the current public dietary advice in Norway. Thus, the objective of this study is to investigate whether a multi-faceted dietary intervention could increase compliance to the NFBDG and affect biomarkers of chronic degenerative diseases in a healthy population.

Detailed Description
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The study was conducted as part of a master level course in Clinical Nutrition at the University of Oslo. Thus, the main objective of the study was to teach the master students about planning, conducting and analysing data from a clinical trial. The students themselves are subjects of the study, however the participation in the study was voluntary and did in no way affect the approval of the course. Since the primary objective of the study was teaching, the study was confirmed by the Regional Committees for Medical and Health Research Ethics (REC) to be exempt from REC approval.

Conditions
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Dietary Modification

Intervention / Treatment
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* Other: NFBDG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female Exclusion Criteria: serious chronic disease requiring medication pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NFBDG<br>Multi-faceted, 2 week intervention to increase compliance to the NFBDG. | Other: NFBDG<br>* Intervention consists of: Lecture presenting the NFBDG, Printed booklet containing the NFBDG, Suggested meal plan for a week, Recipes, Access to a restricted website with further information on the NFBDG, A Facebook-group where Vegetable of the day was presented with a suggested recipe, text-messages with encouragement to follow the guidelines, follow-up phone-calls, common exercise sessions, Free common meals (1 breakfast, 2 lunches, 1 dinner), Free foods (low-fat dairy products, a juice containing grapes, blueberries, chokeberries, and cherries and fruits)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker of the intake of fruits and vegetables (caroteniods in plasma (uM) |  | 2 weeks | 
| Biomarker of intake of fatty fish and low fat dairy products (fatty acids in red blood cells (fatty acid in % of FAME) | fatty acids in red blood cells (fatty acid in % of FAME) | 2 weeks | 
| Biomarker of the intake of fruits and vegetables (total antioxidant status in plasma (RU) |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipids in plasma (HDL, LDL, total cholesterol) | HDL, LDL, total cholesterol | 2 weeks | 
| Blood glucose |  | 2 weeks | 
| Blood pressure | Blood pressure (mmHg) | 2 weeks | 
| Weight (body weight in kg) | body weight in kg | 2 weeks | 
| Body composition (bioelectrocal impedance analysis (BIA) | bioelectrocal impedance analysis (BIA) | 2 weeks |