Challenges in Achieving Adequate Dietary Status of Women
NCT ID: NCT06745817
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
300 participants
OBSERVATIONAL
2025-01-06
2026-12-31
Brief Summary
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Detailed Description
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Further we will investigate links between dietary behaviours with nutritional and health status in order to identify increased nutritional and health risk, as well as potential benefits of different dietary practices. We will particularly focus into following sub-groups of women: omnivorous women, that do not follow any special diet, women that follow vegetarian diet, and women that follow vegan diet. In order to investigate the status of the key micronutrients, standard blood biomarkers will be used. This will allow us to determine nutritional status for iron, folate, vitamin B12 and vitamin D. Body composition will be estimated using bioelectrical impedance spectroscopy (BIS). Other measurements of health-related parameters will include tissue protein density using ultrasonography.
Study results will give insights into the nutritional status in general group of women of reproductive age and enable us to identify links between dietary behaviours with nutritional as well as health status. Through that approach we will be able to identify potential risk for deficiencies of nutrients in studied population group.
Applying a highly multidisciplinary approach and building on previous research we will address the following:
* evaluate dietary behaviours of women of reproductive age (20-49 years) through representative sampling approach. This will enable identification of diet related risks in this group.
* determine dietary supplementation practices of women of reproductive age (20-49 years). This will allow us to better estimate intakes of specific nutrients, as supplements can be important dietary source of nutrients.
* investigate nutritional status of women of reproductive age (20-49 years) in Slovenia with a combination of validated standard dietary assessment methods and blood biomarkers. This will enable also insights in nutritional status for key micronutrients, including iron, folate, vitamin B12 and vitamin D.
* investigate links between dietary behaviours with nutritional/health status, providing information about sub-populations with higher health risks. To enable this, population of omnivorous subjects will be compared with those on vegetarian and vegan diet.
Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
CROSS_SECTIONAL
Study Groups
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Part 1 sample
Adult women (20-49 years) with different dietary habits
Screening questionnaire
Screening questionnaire: assessment of socio-demographic parameters, use of food supplements, health status, dietary habits
Part 2 sample
Adult women (20-49 years) with different dietary habits invited from Part 1, including also subsamples of vegans, vegetarians, omnivores
Assessement of nutritional status
Assessment of socio-demographic parameters, anthropometric and body composition parameters, food intake (dietary recalls, food propensity questionnaire) and nutritional status (blood biomarkers)
Dermis density and thickness
Dermis density and thickness will be measured using ultrasonography with Cortex DermaLab 20 MHz US probe.
Skin elasticity
Skin elasticity will be measured using Cortex DermaLab elasticity probe.
Body composition measurement
Body composition will be measured using Biostat Multiscan 5000.
Screening questionnaire
Screening questionnaire: assessment of socio-demographic parameters, use of food supplements, health status, dietary habits
Interventions
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Assessement of nutritional status
Assessment of socio-demographic parameters, anthropometric and body composition parameters, food intake (dietary recalls, food propensity questionnaire) and nutritional status (blood biomarkers)
Dermis density and thickness
Dermis density and thickness will be measured using ultrasonography with Cortex DermaLab 20 MHz US probe.
Skin elasticity
Skin elasticity will be measured using Cortex DermaLab elasticity probe.
Body composition measurement
Body composition will be measured using Biostat Multiscan 5000.
Screening questionnaire
Screening questionnaire: assessment of socio-demographic parameters, use of food supplements, health status, dietary habits
Eligibility Criteria
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Inclusion Criteria
* Gender: female
* Agrees to participate in the study (has signed a consent form)
Vegetarians:
* Have followed a vegetarian diet for at least 2 years and do not consume meat or fish more than once a month
* Consume eggs and dairy products more than once a month
Vegans:
\- Have followed a vegan diet for at least 2 years and do not consume any animal products more than once a month
Exclusion Criteria
* Pregnancy
Reasons for excluding a participant during the study:
* Inability to participate in the study
* Wishes to discontinue participation
* Incomplete data provided
20 Years
49 Years
FEMALE
Yes
Sponsors
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National Institute of Public Health, Slovenia
OTHER_GOV
VIST - Faculty of Applied Sciences
OTHER
Institute of Nutrition, Slovenia (Nutris)
OTHER
Responsible Party
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Principal Investigators
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Katja Zmitek, PhD
Role: STUDY_CHAIR
Nutrition Institute, Ljubljana
Locations
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National Institute of Public Health, Slovenia
Ljubljana, , Slovenia
Nutrition Institute, Ljubljana
Ljubljana, , Slovenia
VIST Fakulteta za aplikativne vede Zmitek
Ljubljana, , Slovenia
Countries
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Other Identifiers
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L3-50125
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
L3-50125
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
KEP-4-14/2024
Identifier Type: -
Identifier Source: org_study_id
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