NCT05438966

Brief Summary

There is objective need to examine nutritional status (i.e., body mass index (BMI), body composition and dietary intake) of healthy adult Slovenes after SARS-CoV-2 (Covid-19) epidemic period. In the Slovenian (pair of European Union) adult population (with only 2 million inhabitants), we do not yet have representative data on the body composition of adult Slovenes published in the scientific literature. In the study after the Covid-19 pandemic period (4th wave) the investigators will use medically approved body analyzer (Tanita 780 S MA, Tokyo, Japan) and standardized food frequency questionnaire (FFQ). In addition, the investigators will measured body height of the participants with a portable altimeter (ADE MZ10042, Germany). The research will include randomly recruited adults (participants) who will attend various free or/and paid publicly available seminars, congresses and fairs in Slovenia, directly unrelated topics to physical activity or healthy eating (i.e., healthy and active lifestyle) thus obtaining a more realistic current population status.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
833

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

June 28, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 2, 2022

Status Verified

September 1, 2022

Enrollment Period

2 months

First QC Date

June 28, 2022

Last Update Submit

September 1, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • Body weight status

    Body weight measured with medically approved body composition monitor

    June-September 2022

  • Height status

    Height status measured with medically approved weighing scale with height rod

    June-September 2022

  • Body mass index (BMI) status

    Measured body weight and body height will be combined to report BMI in kg/m2

    June-September 2022

  • Body fat percentege status

    Body fat percentage measured with medically approved body composition monitor

    June-September 2022

  • Muscle mass percantage status

    Muscle mass percantage measured with medically approved body composition monitor

    June-September 2022

Secondary Outcomes (1)

  • Dietary intake status

    June-September 2022

Interventions

No intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy adult Slovenes

You may qualify if:

  • Healthy adults
  • No BMI restriction
  • Randomly invited

You may not qualify if:

  • Without currently competitive or top level athletes
  • Without pregnant or lactating women and physically handicapped individuals
  • Without active common chronic diseases (i.e., cancer, CVD, autoimmune diseases ect.)
  • Without individuals with a pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of sport

Ljubljana, 1000, Slovenia

Location

Related Publications (5)

  • Pravst I, Lavrisa Z, Hribar M, Hristov H, Kvarantan N, Seljak BK, Gregoric M, Blaznik U, Gregoric N, Zaletel K, Oblak A, Osredkar J, Zmitek K, Kusar A. Dietary Intake of Folate and Assessment of the Folate Deficiency Prevalence in Slovenia Using Serum Biomarkers. Nutrients. 2021 Oct 28;13(11):3860. doi: 10.3390/nu13113860.

    PMID: 34836112BACKGROUND
  • Clarys P, Deliens T, Huybrechts I, Deriemaeker P, Vanaelst B, De Keyzer W, Hebbelinck M, Mullie P. Comparison of nutritional quality of the vegan, vegetarian, semi-vegetarian, pesco-vegetarian and omnivorous diet. Nutrients. 2014 Mar 24;6(3):1318-32. doi: 10.3390/nu6031318.

    PMID: 24667136BACKGROUND
  • De Keyzer W, Dekkers A, Van Vlaslaer V, Ottevaere C, Van Oyen H, De Henauw S, Huybrechts I. Relative validity of a short qualitative food frequency questionnaire for use in food consumption surveys. Eur J Public Health. 2013 Oct;23(5):737-42. doi: 10.1093/eurpub/cks096. Epub 2012 Jul 26.

    PMID: 22843611BACKGROUND
  • Korosec M, Golob T, Bertoncelj J, Stibilj V, Seljak BK. The Slovenian food composition database. Food Chem. 2013 Oct 1;140(3):495-9. doi: 10.1016/j.foodchem.2013.01.005. Epub 2013 Jan 17.

    PMID: 23601397BACKGROUND
  • Verney J, Schwartz C, Amiche S, Pereira B, Thivel D. Comparisons of a Multi-Frequency Bioelectrical Impedance Analysis to the Dual-Energy X-Ray Absorptiometry Scan in Healthy Young Adults Depending on their Physical Activity Level. J Hum Kinet. 2015 Oct 14;47:73-80. doi: 10.1515/hukin-2015-0063. eCollection 2015 Sep 29.

    PMID: 26557191BACKGROUND

MeSH Terms

Conditions

Body WeightCOVID-19

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Boštjan Jakše, PhD

    Independent Researcher

    PRINCIPAL INVESTIGATOR
  • Stanislav Pinter, PhD

    University of Ljubljana

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Boštjan Jakše, Principal Investigator

Study Record Dates

First Submitted

June 28, 2022

First Posted

June 30, 2022

Study Start

June 28, 2022

Primary Completion

August 31, 2022

Study Completion

September 1, 2022

Last Updated

September 2, 2022

Record last verified: 2022-09

Locations