Adults Nutrition as a Protective or Health-risk Factor (NUTRIHEALTH)

February 23, 2021 updated by: Nutrition Institute, Slovenia

NUTRIHEALTH - Adults Nutrition as a Protective or Health-risk Factor

To obtain up-to-date data on nutrient intakes in adults, a national dietary survey - the EU Menu study will be conducted during 12 consecutive months in 2017/2018, providing data on the consumption of foods and enabling the assessment of energy and macronutrient intakes. Participating subjects will be invited to NUTRIHEALTH study for assessment for micronutrient status (focusing into vitamin D, folic acid, vitamin B12, and iron) and medical examination, in which thyroid size will be aslo measured, to investigated thyroid epidemiology in Slovenia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Medical Centre Ljubljana
      • Ljubljana, Slovenia, 1000
        • Nutrition Institute, Ljubljana
      • Ljubljana, Slovenia, 1000
        • National Institute of Public Health, Slovenia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This observational study is conducted on randomly selected residents of Republic of Slovenia. The EU Menu study (LOT2) include a minimum of 1.133 of habitants from Slovenia in the age 18-74 years. In line with the EU Menu methodology and to ensure representativeness of the sample, participants will be randomly selected from the Slovenian population using Central Population Register (selection outsourced by the Statistical Office of Republic of Slovenia ), and visited on their home. After completion of the EU Menu Survey (questionnaires on self-reported health status and food intake), participants will be invited to collaborate in the proposed study.

Description

Inclusion Criteria:

  • Resident of Republic of Slovenia (included to the register of residents)
  • Finished EU MENU Slovenia Study

Exclusion Criteria:

  • Not willing to give blood&urine sample
  • Long-term disease
  • Living in institutions with controled diet, such as such as in elderly care, hospital, prison, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adults (18-65 years)
Diagnostic test: Assessement of nutritional status
Nutritional status for vitamin D, folic acid, vitamin B12 and iron.
Diagnostic test: Thyroid size
Thyroid size by ultrasound.
Elderly (65-74 years)
Diagnostic test: Assessement of nutritional status
Nutritional status for vitamin D, folic acid, vitamin B12 and iron.
Diagnostic test: Thyroid size
Thyroid size by ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of inadequate vitamin D status
Time Frame: 1 year
epidemiology of vitamin D status will be investigated
1 year
Assessment of thyroid health
Time Frame: 1 year
epidemiology of thyroid Health will be investigated
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of inadequate vitamin B12 status
Time Frame: 1 years
epidemiology of vitamin 12 status will be investigated
1 years
Assessment of inadequate folic acid status
Time Frame: 1 years
epidemiology of folic acid status will be investigated
1 years
Assessment of inadequate iron status
Time Frame: 1 years
epidemiology of iron status will be investigated
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nutrition Institute, Slovenia

Collaborators

National Institute of Public Health, Slovenia
University Medical Centre Ljubljana

Investigators

  • Study Chair: Igor Pravst, PhD, Nutrition Institute, Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

September 13, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

September 13, 2017

First Submitted That Met QC Criteria

September 13, 2017

First Posted (Actual)

September 15, 2017

Study Record Updates

Last Update Posted (Actual)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KME72/07/16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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