Clinical trial NCT03284840: Adults Nutrition as a Protective or Health-risk Factor
Official title: NUTRIHEALTH - Adults Nutrition as a Protective or Health-risk Factor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Lead sponsor: Nutrition Institute, Slovenia
Sponsor class: OTHER
Collaborators: name: National Institute of Public Health, Slovenia
name: University Medical Centre Ljubljana
First posted: 2017-09-15
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of inadequate vitamin D status
timeFrame: 1 year
measure: Assessment of thyroid health
timeFrame: 1 year
Secondary outcomes:
measure: Assessment of inadequate vitamin B12 status
timeFrame: 1 years
measure: Assessment of inadequate folic acid status
timeFrame: 1 years
measure: Assessment of inadequate iron status
timeFrame: 1 years
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: National Institute of Public Health, Slovenia
city: Ljubljana
country: Slovenia
facility: Nutrition Institute, Ljubljana
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: Nutrition Institute, Ljubljana
name: Igor Pravst, PhD
role: STUDY_CHAIR
References: