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OpenTrials
Completed

NCT Number: NCT05438966

Nutritional 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.

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.

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Key information

Conditions

Body Weight COVID-19 COVID-19 Pandemic Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Nutrition, Healthy Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of sport

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Body weight status

    Time frame: June-September 2022

    Body weight measured with medically approved body composition monitor

  2. Height status

    Time frame: June-September 2022

    Height status measured with medically approved weighing scale with height rod

  3. 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

  4. Body fat percentege status

    Time frame: June-September 2022

    Body fat percentage measured with medically approved body composition monitor

  5. Muscle mass percantage status

    Time frame: June-September 2022

    Muscle mass percantage measured with medically approved body composition monitor

Secondary outcomes

  1. Dietary intake status

    Time frame: June-September 2022

    Dietary intake measured by standardized food frequency questionnaire

Sponsors and collaborators

Lead sponsor

Barbara Jakše s.p.

Other

Registry information

Official study title

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

Acronym: SloFitCovid

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 30, 2022
Registry last updated
Sep 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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