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Completed

NCT Number: NCT02416284

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

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.

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Key information

Conditions

Dietary Modification

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Oslo

Oslo, 0316, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female

Exclusion criteria

  • serious chronic disease requiring medication
  • pregnancy

Treatment and study plan

NFBDG

Other

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)

Primary outcomes

  1. Biomarker of the intake of fruits and vegetables (caroteniods in plasma (uM)

    Time frame: 2 weeks

  2. Biomarker of intake of fatty fish and low fat dairy products (fatty acids in red blood cells (fatty acid in % of FAME)

    Time frame: 2 weeks

    fatty acids in red blood cells (fatty acid in % of FAME)

  3. Biomarker of the intake of fruits and vegetables (total antioxidant status in plasma (RU)

    Time frame: 2 weeks

Secondary outcomes

  1. Lipids in plasma (HDL, LDL, total cholesterol)

    Time frame: 2 weeks

    HDL, LDL, total cholesterol

  2. Blood glucose

    Time frame: 2 weeks

  3. Blood pressure

    Time frame: 2 weeks

    Blood pressure (mmHg)

  4. Weight (body weight in kg)

    Time frame: 2 weeks

    body weight in kg

  5. Body composition (bioelectrocal impedance analysis (BIA)

    Time frame: 2 weeks

    bioelectrocal impedance analysis (BIA)

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 15, 2015
Registry last updated
Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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