Adults Nutrition as a Protective or Health-risk Factor

NCT03284840 | Completed

• 1 other identifier: KME72/07/16
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (2)

• Assessment of inadequate vitamin D status

  epidemiology of vitamin D status will be investigated

  1 year

• Assessment of thyroid health

  epidemiology of thyroid Health will be investigated

  1 year

Secondary Outcomes (3)

• Assessment of inadequate vitamin B12 status

  1 years

• Assessment of inadequate folic acid status

  1 years

• Assessment of inadequate iron status

  1 years

Study Arms (2)

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

Assessement of nutritional status DIAGNOSTIC_TEST

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

Adults (18-65 years); Elderly (65-74 years)

Thyroid size DIAGNOSTIC_TEST

Thyroid size by ultrasound.

Adults (18-65 years); Elderly (65-74 years)

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Nutrition, Slovenia (Nutris): lead
• National Institute of Public Health, Slovenia: collaborator
• University Medical Centre Ljubljana: collaborator

Study Sites (3)

National Institute of Public Health, Slovenia

Ljubljana, 1000, Slovenia

Location

Nutrition Institute, Ljubljana

Ljubljana, 1000, Slovenia

Location

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be freezed for possible further analyses on markers related with nutrition \& health

MeSH Terms

Conditions

Vitamin D Deficiency; Vitamin B 12 Deficiency; Folic Acid Deficiency; Anemia, Iron-Deficiency; Thyroid Diseases

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Vitamin B Deficiency; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Igor Pravst, PhD

  Nutrition Institute, Ljubljana

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 15, 2017
• Study Start: June 1, 2017
• Primary Completion: September 13, 2018
• Study Completion: December 31, 2018
• Last Updated: February 24, 2021

Record last verified: 2020-02

Locations

SL (3)