An observational study in Nutritional Status, Nutrient Deficiency and Micronutrient Deficiency, sponsored by Nutrition Institute, Slovenia. Enrolling by invitation at 3 sites in Slovenia. Open to female participants aged 20 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-19.
Sponsored by Nutrition Institute, Slovenia · Observational
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.
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:
At least 3,000 women (20-49) from the Central Slovenia will be randomly invited to participate (selection by the Statistical Office of the Republic of Slovenia). We aim for 1,650 responding participants.
In Part 2, we will include 294 participants from Part 1:
To ensure enough participants for Part 2, 550 individuals will be invited. They will be selected using stratified random sampling by age. If needed, we will use the snowball method to recruit more vegetarians and vegans.
Exclusion criteria:
Reasons for excluding a participant during the study:
Additional inclusion criteria for including subpopulations in the second part of the study:
Vegetarians:
Vegans:
Adult women (20-49 years) with different dietary habits
Diagnostic Test: Screening questionnaire
Adult women (20-49 years) with different dietary habits invited from Part 1, including also subsamples of vegans, vegetarians, omnivores
Diagnostic Test: Assessement of nutritional status · Diagnostic Test: Dermis density and thickness · Diagnostic Test: Skin elasticity · Diagnostic Test: Body composition measurement · Diagnostic Test: Screening questionnaire
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 will be measured using ultrasonography with Cortex DermaLab 20 MHz US probe.
Skin elasticity will be measured using Cortex DermaLab elasticity probe.
Body composition will be measured using Biostat Multiscan 5000.
Screening questionnaire: assessment of socio-demographic parameters, use of food supplements, health status, dietary habits
Assessment of nutrient intake
epidemiology of nutrients intake will be investigated from food records (dietary recalls, food propensity questionaires) \[g/day\]
Time frame: 1 year
Assessment of nutritional deficiencies
epidemiology of nutritional deficiencies will be investigated using blood biomarkers
Time frame: 1 year
Assessment of inadequate vitamin D status
epidemiology of vitamin D status will be investigated using serum 25-OH-vitamin D concentration
Time frame: 1 year
Assessment of inadequate vitamin B12 status
epidemiology of vitamin B12 status will be investigated using serum vitamin B12 concentration
Time frame: 1 year
Assessment of inadequate folate status
epidemiology of vitamin folate status will be investigated using serum folate concentration
Time frame: 1 year
Assessment of inadequate iron status
epidemiology of vitamin folate status will be investigated using serum ferritin concentration
Time frame: 1 year
Assessment of body composition
epidemiology of body composition will be investigated using Bioimpedance Spectroscopy (BIS) which measures at 50 frequencies ranging from 5 kHz to 1000 kHz giving values for impedance, resistance and reactance of the tissues (all in Ohms) from which body composition (proportion of lean and fat mass) values are calculated.
Time frame: 1 year
Assessment of dermal thickness
epidemiology of dermal thickness will be measured using 20 MHz ultrasonography in micrometers
Time frame: 1 year
Assessment of dermal density
epidemiology of dermal density will be measured using 20 MHz ultrasonography as an intensity score 0-100
Time frame: 1 year
Assessment of skin elasticity
epidemiology of skin elasticity will be measured using Cortex DermaLab elasticity measurement
Time frame: 1 year
Body mass index (BMI) epidemiology of dietary intake of nutrients and fibre will be investigated from food records [g/day]
Weight and height will be combined to report BMI in kg/m\^2 and providing insights into prevalence of overweight/obesity
Time frame: 1 year
Physical activity
epidemiology of physical activity levels will be investigated using International Physical Activity Questionnaire (IPAQ) - Short Form
Time frame: 1 year
Muscle strength
Muscle strength will be measured as grip strength using dynamometer
Time frame: 1 year
Plan to share: No
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Nutrition Institute, Slovenia