Challenges in Achieving Adequate Dietary Status of Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Assessement of nutritional status, Dermis density and thickness, Skin elasticity, Body composition measurement.
- Who it may be relevant to
- Registry conditions: Nutritional Status, Nutrient Deficiency, Micronutrient Deficiency, Vitamin D Deficiency. Basic parameters: 20 years — 49 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Challenges in Achieving Adequate Dietary Status of Women of Reproductive Age (NutriFem)
Overview
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
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.
Interventions
- Diagnostic test 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) - Diagnostic test Dermis density and thickness
Dermis density and thickness will be measured using ultrasonography with Cortex DermaLab 20 MHz US probe. - Diagnostic test Skin elasticity
Skin elasticity will be measured using Cortex DermaLab elasticity probe. - Diagnostic test Body composition measurement
Body composition will be measured using Biostat Multiscan 5000. - Diagnostic test Screening questionnaire
Screening questionnaire: assessment of socio-demographic parameters, use of food supplements, health status, dietary habits
Primary outcome measures
- Assessment of nutrient intake [Time frame: 1 year]
- Assessment of nutritional deficiencies [Time frame: 1 year]
Secondary outcome measures (8)
- Assessment of inadequate vitamin D status [Time frame: 1 year]
- Assessment of inadequate vitamin B12 status [Time frame: 1 year]
- Assessment of inadequate folate status [Time frame: 1 year]
- Assessment of inadequate iron status [Time frame: 1 year]
- Assessment of body composition [Time frame: 1 year]
- Assessment of dermal thickness [Time frame: 1 year]
- Assessment of dermal density [Time frame: 1 year]
- Assessment of skin elasticity [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Age: 20 to 49 years
- Gender: female
- Agrees to participate in the study (has signed a consent form)
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
Additional inclusion criteria for including subpopulations in the second part of the study:
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Ecologic or community
Study locations
Slovenia · 3 centers
- National Institute of Public Health, Slovenia — Ljubljana
- Nutrition Institute, Ljubljana — Ljubljana
- VIST Fakulteta za aplikativne vede Zmitek — Ljubljana
Identifiers
NCT: NCT06745817 · KEP-4-14/2024 · L3-50125 · L3-50125