Clinical trial NCT05438966: Nutritional Status of Adult Slovenes After the Covid-19 Epidemic
Official title: Body Composition and Dietary Intake Status of Adult Slovenes After the Covid-19 Epidemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Weight
Nutrition, Healthy
COVID-19 Pandemic
Lead sponsor: Barbara Jakše s.p.
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 833
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adult Slovenes

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.

Detailed description: In the study investigators will randomly but voluntarily enroll 700-1000 healthy adult participants within inclusion/exclusion criteria that are willing to participate in the study. Investigators anticipate that for this number of adults (aged 18-80 years) will require approx. 5000 invited candidates (10-15 events), of both sexes.

The methods to be used are body composition monitor and FFQ. In addition to the assessment of BMI and body composition status, we will compare the proportion of obese subjects according to BMI and body fat percentage threshold criteria (by World Health Organization). For the dietary intake analysis the investigators will use the national a dietary software program, OPEN Platform for Clinical Nutrition, which is a web-based application developed by the Jožef Stefan Institute in Slovenia.

The power of the sample was calculated on the basis of published body composition data on the adult population of the scientific monographs of the Slovenian National Institute of Public Health and data on the BMI of the scientific research on the dietary intake status of adults (SI.Menu).

The participants included in the study will signed consent form for inclusion in the study and will not be remunerated financially for participation in the study.

Eligibility criteria: Inclusion Criteria:

* Healthy adults
* No BMI restriction
* Randomly invited

Exclusion Criteria:

* 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

Primary outcomes:
measure: Body weight status
timeFrame: June-September 2022
measure: Height status
timeFrame: June-September 2022
measure: Body mass index (BMI) status
timeFrame: June-September 2022
measure: Body fat percentege status
timeFrame: June-September 2022
measure: Muscle mass percantage status
timeFrame: June-September 2022
Secondary outcomes:
measure: Dietary intake status
timeFrame: June-September 2022
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Faculty of sport
Study officials:
affiliation: Independent Researcher
name: Boštjan Jakše, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ljubljana
name: Stanislav Pinter, PhD
role: STUDY_CHAIR
References:
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citation: 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.
citation: 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.