Challenges in Achieving Adequate Dietary Status of Women

NCT ID: NCT06745817

Last Updated: 2025-03-19

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-06

Study Completion Date

2026-12-31

Brief Summary

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The aim of the study is to investigate the dietary habits of women of reproductive age (20-49 years). We aim to obtain epidemiological data on the intake and adequacy of key macronutrients and micronutrients, as well as to explore associations with various health indicators. Additionally, we will focus on the nutritional status of subgroups with specific dietary practices, such as vegetarians and vegans.

Detailed Description

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Key scientific challenges addressed in this study are to investigate the dietary habits and nutritional status of women of reproductive age, to provide epidemiological data on the nutrient intakes in this group (including intakes of key micronutrients) and investigate their relationship with various markers of health. We will evaluate dietary behaviours and special dietary practices among women of reproductive age in Slovenia, through age-representative sampling approach. We will also detailly assess dietary supplementation practices in this population group. Dietary intakes of macro and key micronutrients and nutritional/health status will be evaluated using a cross-sectional epidemiological study.

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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Nutritional Status Nutrient Deficiency Micronutrient Deficiency Vitamin D Deficiency Vitamin B 12 Deficiency Folic Acid Deficiency Iron-deficiency Diet Dermis Density Dermis Thickness Skin Elasticity Body Composition Physical Activity

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Part 1 sample

Adult women (20-49 years) with different dietary habits

Screening questionnaire

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Dermis density and thickness will be measured using ultrasonography with Cortex DermaLab 20 MHz US probe.

Skin elasticity

Intervention Type DIAGNOSTIC_TEST

Skin elasticity will be measured using Cortex DermaLab elasticity probe.

Body composition measurement

Intervention Type DIAGNOSTIC_TEST

Body composition will be measured using Biostat Multiscan 5000.

Screening questionnaire

Intervention Type DIAGNOSTIC_TEST

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)

Intervention Type DIAGNOSTIC_TEST

Dermis density and thickness

Dermis density and thickness will be measured using ultrasonography with Cortex DermaLab 20 MHz US probe.

Intervention Type DIAGNOSTIC_TEST

Skin elasticity

Skin elasticity will be measured using Cortex DermaLab elasticity probe.

Intervention Type DIAGNOSTIC_TEST

Body composition measurement

Body composition will be measured using Biostat Multiscan 5000.

Intervention Type DIAGNOSTIC_TEST

Screening questionnaire

Screening questionnaire: assessment of socio-demographic parameters, use of food supplements, health status, dietary habits

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age: 20 to 49 years
* 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

* Menopause (absence of menstruation for at least 12 months, unless the absence is due to hormonal contraception) or post-menopause
* Pregnancy

Reasons for excluding a participant during the study:

* Inability to participate in the study
* Wishes to discontinue participation
* Incomplete data provided
Minimum Eligible Age

20 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Public Health, Slovenia

OTHER_GOV

Sponsor Role collaborator

VIST - Faculty of Applied Sciences

OTHER

Sponsor Role collaborator

Institute of Nutrition, Slovenia (Nutris)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Nutrition Institute, Ljubljana

Ljubljana, , Slovenia

Site Status

VIST Fakulteta za aplikativne vede Zmitek

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

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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