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

Dietary Modification Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02416284
• Other study ID #: ERN4120_2012
• Status: Completed
• Phase: N/A
• First received: April 3, 2015
• Last updated: April 14, 2015
• Start date: September 2012
• Est. completion date: November 2012

Study information

• Verified date: April 2015
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• female

Exclusion Criteria:

• serious chronic disease requiring medication

• pregnancy

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Dietary Modification

Intervention

Other:
• NFBDG
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)

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarker of the intake of fruits and vegetables (caroteniods in plasma (uM)		2 weeks	No
Primary	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	No
Primary	Biomarker of the intake of fruits and vegetables (total antioxidant status in plasma (RU)		2 weeks	No
Secondary	Lipids in plasma (HDL, LDL, total cholesterol)	HDL, LDL, total cholesterol	2 weeks	No
Secondary	Blood glucose		2 weeks	No
Secondary	Blood pressure	Blood pressure (mmHg)	2 weeks	No
Secondary	Weight (body weight in kg)	body weight in kg	2 weeks	No
Secondary	Body composition (bioelectrocal impedance analysis (BIA)	bioelectrocal impedance analysis (BIA)	2 weeks	No