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CompletedNCT03284840NUTRIHEALTHUpdated Feb 24, 2021

Adults Nutrition as a Protective or Health-risk Factor

An observational study in Nutritional Status, Nutrient Deficiency and Micronutrient Deficiency, sponsored by Nutrition Institute, Slovenia. Completed at 3 sites in Slovenia. Open to participants aged 18 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-24.

Sponsored by Nutrition Institute, Slovenia · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
280
Ages
18 Years to 74 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Nutritional Status
  • Nutrient Deficiency
  • Micronutrient Deficiency
  • Vitamin D Deficiency
  • Vitamin B 12 Deficiency
  • Folic Acid Deficiency
  • Iron-deficiency
  • Thyroid Diseases
  • Diet

Keywords

  • dietary intake
  • nutritional status
  • micronutrients
  • thyroid health
03

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
280 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Adults (18-65 years)

    Diagnostic Test: Assessement of nutritional status · Diagnostic Test: Thyroid size

  • Elderly (65-74 years)

    Diagnostic Test: Assessement of nutritional status · Diagnostic Test: Thyroid size

Interventions

  • Diagnostic testAssessement of nutritional status

    Nutritional status for vitamin D, folic acid, vitamin B12 and iron.

  • Diagnostic testThyroid size

    Thyroid size by ultrasound.

05

What researchers measure

Primary outcomes

  1. Assessment of inadequate vitamin D status

    epidemiology of vitamin D status will be investigated

    Time frame: 1 year

  2. Assessment of thyroid health

    epidemiology of thyroid Health will be investigated

    Time frame: 1 year

Secondary outcomes

  1. Assessment of inadequate vitamin B12 status

    epidemiology of vitamin 12 status will be investigated

    Time frame: 1 years

  2. Assessment of inadequate folic acid status

    epidemiology of folic acid status will be investigated

    Time frame: 1 years

  3. Assessment of inadequate iron status

    epidemiology of iron status will be investigated

    Time frame: 1 years

06

Study locations

3 sites
  • National Institute of Public Health, Slovenia
    Ljubljana, 1000, Slovenia
  • Nutrition Institute, Ljubljana
    Ljubljana, 1000, Slovenia
  • University Medical Centre Ljubljana
    Ljubljana, 1000, Slovenia
07

Registry details

Key details

Study ID
NCT03284840
Lead sponsor
Nutrition Institute, Slovenia
Collaborators
National Institute of Public Health, Slovenia, University Medical Centre Ljubljana
Responsible party
Sponsor
First posted
Sep 15, 2017
Start date
Jun 1, 2017
Primary completion
Sep 13, 2018
Completion
Dec 31, 2018
Last update
Feb 24, 2021

Study contacts

Igor Pravst, PhD
study chair · Nutrition Institute, Ljubljana

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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