Body WeightSloFitCovidNCT05438966
Nutritional Status of Adult Slovenes After the Covid-19 Epidemic
An observational study of Body Weight and Nutrition, Healthy, run by Barbara Jakše s.p. at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight, Nutrition, Healthy, COVID-19 Pandemic
- How many people
- 833 participants
- Where
- 1 siteSlovenia
- Study dates
- 28 Jun 2022to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult Slovenes
Who may be able to join
- Healthy adults
- No BMI restriction
- Randomly invited
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Body Composition and Dietary Intake Status of Adult Slovenes After the Covid-19 Epidemic
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.
Read more
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.
Read the 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
- Being tested
- No intervention
- Medical subject headings
- Body Weight, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight status
Body weight measured with medically approved body composition monitor
Measured: June-September 2022
Height status
Height status measured with medically approved weighing scale with height rod
Measured: June-September 2022
Body mass index (BMI) status
Measured body weight and body height will be combined to report BMI in kg/m2
Measured: June-September 2022
Body fat percentege status
Body fat percentage measured with medically approved body composition monitor
Measured: June-September 2022
Muscle mass percantage status
Muscle mass percantage measured with medically approved body composition monitor
Measured: June-September 2022
Secondary outcomes (1)
Dietary intake status
Dietary intake measured by standardized food frequency questionnaire
Measured: June-September 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start28 Jun 2022
- Primary completion31 Aug 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Body WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 833 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Jakše s.p.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boštjan Jakše, Barbara Jakše s.p.
- Investigators
- Boštjan Jakše, PhD, Principal investigator, Independent ResearcherStanislav Pinter, PhD, Study chair, University of Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438966
- Sponsor's protocol ID
- KR6
- Acronym
- SloFitCovid
- Status last verified
- Sep 2022
- First submitted
- 28 Jun 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34836112Clarys 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.
PubMed 24667136De 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.
PubMed 22843611Korosec 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.
PubMed 23601397Verney 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.
PubMed 26557191
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition and Dietary Intake Status of Adult Slovenes After the Covid-19 Epidemic
- ClinicalTrials.gov ID
- NCT05438966
- Acronym / sponsor ID
- SloFitCovid / KR6
- Conditions
- Body Weight, Nutrition, Healthy, COVID-19 Pandemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 833 participants (actual)
- Lead sponsor
- Barbara Jakše s.p.University, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult Slovenes
Key inclusion criteria (3 listed)
- Healthy adults
- No BMI restriction
- Randomly invited
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Body weight status
Time frame: June-September 2022
Body weight measured with medically approved body composition monitor
Height status
Time frame: June-September 2022
Height status measured with medically approved weighing scale with height rod
Body mass index (BMI) status
Time frame: June-September 2022
Measured body weight and body height will be combined to report BMI in kg/m2
Body fat percentege status
Time frame: June-September 2022
Body fat percentage measured with medically approved body composition monitor
Muscle mass percantage status
Time frame: June-September 2022
Muscle mass percantage measured with medically approved body composition monitor
1 secondary outcome
Dietary intake status
Time frame: June-September 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Background: PubMed 34836112Pravst 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.
- Background: PubMed 24667136Clarys 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.
- Background: PubMed 22843611De 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.
- Background: PubMed 23601397Korosec 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.
- Background: PubMed 26557191Verney 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boštjan Jakše, PhD principal investigator
Independent Researcher
Stanislav Pinter, PhD study chair
University of Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Weight and Nutrition, Healthy, run by Barbara Jakše s.p. at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight status (time frame: June-September 2022). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05438966, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.