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NCT Number: NCT06745817

Challenges in Achieving Adequate Dietary Status of Women

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessement of nutritional status

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

Diagnostic Test

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

Skin elasticity

Diagnostic Test

Skin elasticity will be measured using Cortex DermaLab elasticity probe.

Body composition measurement

Diagnostic Test

Body composition will be measured using Biostat Multiscan 5000.

screening questionnaire

Diagnostic Test

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

Primary outcomes

  1. Assessment of nutrient intake

    Time frame: 1 year

    epidemiology of nutrients intake will be investigated from food records (dietary recalls, food propensity questionaires) [g/day]

  2. Assessment of nutritional deficiencies

    Time frame: 1 year

    epidemiology of nutritional deficiencies will be investigated using blood biomarkers

Secondary outcomes

  1. Assessment of inadequate vitamin D status

    Time frame: 1 year

    epidemiology of vitamin D status will be investigated using serum 25-OH-vitamin D concentration

  2. Assessment of inadequate vitamin B12 status

    Time frame: 1 year

    epidemiology of vitamin B12 status will be investigated using serum vitamin B12 concentration

  3. Assessment of inadequate folate status

    Time frame: 1 year

    epidemiology of vitamin folate status will be investigated using serum folate concentration

  4. Assessment of inadequate iron status

    Time frame: 1 year

    epidemiology of vitamin folate status will be investigated using serum ferritin concentration

  5. Assessment of body composition

    Time frame: 1 year

    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.

  6. Assessment of dermal thickness

    Time frame: 1 year

    epidemiology of dermal thickness will be measured using 20 MHz ultrasonography in micrometers

  7. Assessment of dermal density

    Time frame: 1 year

    epidemiology of dermal density will be measured using 20 MHz ultrasonography as an intensity score 0-100

  8. Assessment of skin elasticity

    Time frame: 1 year

    epidemiology of skin elasticity will be measured using Cortex DermaLab elasticity measurement

Other outcomes

  1. Body mass index (BMI) epidemiology of dietary intake of nutrients and fibre will be investigated from food records [g/day]

    Time frame: 1 year

    Weight and height will be combined to report BMI in kg/m^2 and providing insights into prevalence of overweight/obesity

  2. Physical activity

    Time frame: 1 year

    epidemiology of physical activity levels will be investigated using International Physical Activity Questionnaire (IPAQ) - Short Form

  3. Muscle strength

    Time frame: 1 year

    Muscle strength will be measured as grip strength using dynamometer

Sponsors and collaborators

Lead sponsor

Institute of Nutrition, Slovenia (Nutris)

Other

Collaborators

  • National Institute of Public Health, Slovenia
  • VIST - Faculty of Applied Sciences

Registry information

Official study title

Challenges in Achieving Adequate Dietary Status of Women of Reproductive Age (NutriFem)

Acronym: NutriFem

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 20, 2024
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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