Nutritional Status of Adult Slovenes After the Covid-19 Epidemic

Body Weight Clinical Trial

— SloFitCovid  

Official title:

Body Composition and Dietary Intake Status of Adult Slovenes After the Covid-19 Epidemic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05438966
• Other study ID #: KR6
• Status: Completed
• Start date: June 28, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2022
• Source: Barbara Jakše s.p.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 833
• Est. completion date: September 1, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• COVID-19
• COVID-19 Pandemic

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Slovenia	Faculty of sport	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Barbara Jakše s.p.

Country where clinical trial is conducted

Slovenia, 

References & Publications (5)

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. — View Citation

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. — View Citation

Korošec 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. — View Citation

Pravst I, Lavriša Ž, Hribar M, Hristov H, Kvarantan N, Seljak BK, Gregoric M, Blaznik U, Gregoric N, Zaletel K, Oblak A, Osredkar J, Žmitek K, Kušar A. Dietary Intake of Folate and Assessment of the Folate Deficiency Prevalence in Slovenia Using Serum Biomarkers. Nutrients. 2021 Oct 28;13(11). pii: 3860. doi: 10.3390/nu13113860. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight status	Body weight measured with medically approved body composition monitor	June-September 2022
Primary	Height status	Height status measured with medically approved weighing scale with height rod	June-September 2022
Primary	Body mass index (BMI) status	Measured body weight and body height will be combined to report BMI in kg/m2	June-September 2022
Primary	Body fat percentege status	Body fat percentage measured with medically approved body composition monitor	June-September 2022
Primary	Muscle mass percantage status	Muscle mass percantage measured with medically approved body composition monitor	June-September 2022
Secondary	Dietary intake status	Dietary intake measured by standardized food frequency questionnaire	June-September 2022