Nutritional Status of Adult Slovenes After the Covid-19 Epidemic

NCT ID: NCT05438966

Last Updated: 2022-09-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 833 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-28
• Study Completion Date: 2022-09-01

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.

Conditions

Body Weight; Nutrition, Healthy; COVID-19 Pandemic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

No intervention

No intervention

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Barbara Jakše s.p.

OTHER

Sponsor Role: lead

Responsible Party

Boštjan Jakše

Boštjan Jakše, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Boštjan Jakše, PhD

Role: PRINCIPAL_INVESTIGATOR

Independent Researcher

Stanislav Pinter, PhD

Role: STUDY_CHAIR

University of Ljubljana

Locations

Faculty of sport

Ljubljana, , Slovenia

Countries

Slovenia

References

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Reference Type: BACKGROUND

PMID: 34836112 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24667136 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22843611 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23601397 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26557191 (View on PubMed)

Other Identifiers

KR6

Identifier Type: -

Identifier Source: org_study_id