Nutritional StatusNutriFemNCT06745817
Challenges in Achieving Adequate Dietary Status of Women
An observational study of Nutritional Status and Nutrient Deficiency, run by Institute of Nutrition, Slovenia (Nutris) at 3 sites in Slovenia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nutritional Status, Nutrient Deficiency, Micronutrient Deficiency
- What is being tested?
- Assessement of nutritional status, Dermis density and thickness and Skin elasticity
- How many people
- 300 participants
- Where
- 3 sitesSlovenia
- Study dates
- 6 Jan 2025to 31 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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: * 202 women representative of the study population * 46 vegetarians and 46 vegans 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.
Who may be able to join
- Age: 20 to 49 years
- Gender: female
- Agrees to participate in the study (has signed a consent form)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia3 sites
National Institute of Public Health, Slovenia
Ljubljana, 1000
Nutrition Institute, Ljubljana
Ljubljana, 1000
VIST Fakulteta za aplikativne vede Zmitek
Ljubljana, 1000
About this study
Official title: Challenges in Achieving Adequate Dietary Status of Women of Reproductive Age (NutriFem)
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.
Read the 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.
- Conditions
- Nutritional Status, Nutrient Deficiency, Micronutrient Deficiency, Vitamin D Deficiency, Vitamin B 12 Deficiency, Folic Acid Deficiency
- Being tested
- Assessement of nutritional status, Dermis density and thickness, Skin elasticity, Body composition measurement, Screening questionnaire
- Keywords
- dietary intake, nutritional status, micronutrients
- Medical subject headings
- Vitamin D Deficiency, Vitamin B 12 Deficiency, Folic Acid Deficiency, Anemia, Iron-Deficiency, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessement of nutritional statusDiagnostic 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 thicknessDiagnostic test
Dermis density and thickness will be measured using ultrasonography with Cortex DermaLab 20 MHz US probe.
Skin elasticityDiagnostic test
Skin elasticity will be measured using Cortex DermaLab elasticity probe.
Body composition measurementDiagnostic test
Body composition will be measured using Biostat Multiscan 5000.
Screening questionnaireDiagnostic test
Screening questionnaire: assessment of socio-demographic parameters, use of food supplements, health status, dietary habits
| Study group | Role | What they receive |
|---|---|---|
| Part 1 sample | Adult women (20-49 years) with different dietary habits Receives: Diagnostic Test: Screening questionnaire | |
| Part 2 sample | Adult women (20-49 years) with different dietary habits invited from Part 1, including also subsamples of vegans, vegetarians, omnivores Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of nutrient intake
epidemiology of nutrients intake will be investigated from food records (dietary recalls, food propensity questionaires) [g/day]
Measured: 1 year
Assessment of nutritional deficiencies
epidemiology of nutritional deficiencies will be investigated using blood biomarkers
Measured: 1 year
Secondary outcomes (8)
Assessment of inadequate vitamin D status
epidemiology of vitamin D status will be investigated using serum 25-OH-vitamin D concentration
Measured: 1 year
Assessment of inadequate vitamin B12 status
epidemiology of vitamin B12 status will be investigated using serum vitamin B12 concentration
Measured: 1 year
Assessment of inadequate folate status
epidemiology of vitamin folate status will be investigated using serum folate concentration
Measured: 1 year
Assessment of inadequate iron status
epidemiology of vitamin folate status will be investigated using serum ferritin concentration
Measured: 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.
Measured: 1 year
Assessment of dermal thickness
epidemiology of dermal thickness will be measured using 20 MHz ultrasonography in micrometers
Measured: 1 year
Assessment of dermal density
epidemiology of dermal density will be measured using 20 MHz ultrasonography as an intensity score 0-100
Measured: 1 year
Assessment of skin elasticity
epidemiology of skin elasticity will be measured using Cortex DermaLab elasticity measurement
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start6 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Nutrition, Slovenia (Nutris)
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Public Health, Slovenia, VIST - Faculty of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Katja Zmitek, PhD, Study chair, Nutrition Institute, Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745817
- Sponsor's protocol ID
- KEP-4-14/2024
- Other IDs
- L3-50125, L3-50125
- Acronym
- NutriFem
- Status last verified
- Mar 2025
- First submitted
- 4 Dec 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No