Dietary ModificationNCT02416284
Compliance to the Norwegian Food-Based Dietary Guidelines in Young Females
A study testing NFBDG in people with Dietary Modification, run by University of Oslo at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- NFBDG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2012to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female
Who cannot join
- serious chronic disease requiring medication
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Dietary Modification
- Being tested
- NFBDG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| NFBDG | Experimental | Multi-faceted, 2 week intervention to increase compliance to the NFBDG. Receives: Other: NFBDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker of the intake of fruits and vegetables (caroteniods in plasma (uM)
Measured: 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)
Measured: 2 weeks
Biomarker of the intake of fruits and vegetables (total antioxidant status in plasma (RU)
Measured: 2 weeks
Secondary outcomes (5)
Lipids in plasma (HDL, LDL, total cholesterol)
HDL, LDL, total cholesterol
Measured: 2 weeks
Blood glucose
Measured: 2 weeks
Blood pressure
Blood pressure (mmHg)
Measured: 2 weeks
Weight (body weight in kg)
body weight in kg
Measured: 2 weeks
Body composition (bioelectrocal impedance analysis (BIA)
bioelectrocal impedance analysis (BIA)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startSep 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ModificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rune Blomhoff, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416284
- Sponsor's protocol ID
- ERN4120_2012
- Status last verified
- Apr 2015
- First submitted
- 3 Apr 2015
- Last updated
- 15 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance to the Norwegian Food-Based Dietary Guidelines in Young Females
- ClinicalTrials.gov ID
- NCT02416284
- Acronym / sponsor ID
- ERN4120_2012
- Conditions
- Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NFBDG | Experimental | Other: NFBDGMulti-faceted, 2 week intervention to increase compliance to the NFBDG. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- female
Key exclusion criteria (2 listed)
- serious chronic disease requiring medication
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NFBDGIntervention 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) | Other | NFBDG |
Primary outcome
Biomarker of the intake of fruits and vegetables (caroteniods in plasma (uM)
Time frame: 2 weeks
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)
Biomarker of the intake of fruits and vegetables (total antioxidant status in plasma (RU)
Time frame: 2 weeks
5 secondary outcomes
Lipids in plasma (HDL, LDL, total cholesterol)
Time frame: 2 weeks
Blood glucose
Time frame: 2 weeks
Blood pressure
Time frame: 2 weeks
Weight (body weight in kg)
Time frame: 2 weeks
Body composition (bioelectrocal impedance analysis (BIA)
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NFBDG in people with Dietary Modification, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker of the intake of fruits and vegetables (caroteniods in plasma (uM) (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.