NCT02416284

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

2 months

First QC Date

April 3, 2015

Last Update Submit

April 14, 2015

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Lipids in plasma (HDL, LDL, total cholesterol)

    2 weeks

  • Blood glucose

    2 weeks

  • Blood pressure

    2 weeks

  • Weight (body weight in kg)

    2 weeks

  • Body composition (bioelectrocal impedance analysis (BIA)

    2 weeks

Study Arms (1)

NFBDG

EXPERIMENTAL

Multi-faceted, 2 week intervention to increase compliance to the NFBDG.

Other: NFBDG

Interventions

NFBDGOTHER

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)

NFBDG

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female

You may not qualify if:

  • serious chronic disease requiring medication
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, 0316, Norway

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 3, 2015

First Posted

April 15, 2015

Study Start

September 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations