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Clinical Trials/NCT05438966
NCT05438966
Completed
Not Applicable

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

Barbara Jakše s.p.1 site in 1 country833 target enrollmentJune 28, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Body Weight
Sponsor
Barbara Jakše s.p.
Enrollment
833
Locations
1
Primary Endpoint
Body mass index (BMI) status
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 28, 2022
End Date
September 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Barbara Jakše s.p.
Responsible Party
Principal Investigator
Principal Investigator

Boštjan Jakše

Boštjan Jakše, Principal Investigator

Barbara Jakše s.p.

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

Outcomes

Primary Outcomes

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

Muscle mass percantage status

Time Frame: June-September 2022

Muscle mass percantage measured with medically approved body composition monitor

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 fat percentege status

Time Frame: June-September 2022

Body fat percentage measured with medically approved body composition monitor

Secondary Outcomes

  • Dietary intake status(June-September 2022)

Study Sites (1)

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