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Challenges in Achieving Adequate Dietary Status of Women

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06745817
Acronym
NutriFem
Enrollment
300
Registered
2024-12-20
Start date
2025-01-06
Completion date
2026-12-31
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

dietary intake, nutritional status, micronutrients

Brief 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. 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

Assessment of socio-demographic parameters, anthropometric and body composition parameters, food intake (dietary recalls, food propensity questionnaire) and nutritional status (blood biomarkers)

DIAGNOSTIC_TESTDermis density and thickness

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

DIAGNOSTIC_TESTSkin elasticity

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

Sponsors

National Institute of Public Health, Slovenia
CollaboratorOTHER_GOV
VIST - Faculty of Applied Sciences
CollaboratorOTHER
Institute of Nutrition, Slovenia (Nutris)
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 49 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of nutrient intake1 yearepidemiology of nutrients intake will be investigated from food records (dietary recalls, food propensity questionaires) \[g/day\]
Assessment of nutritional deficiencies1 yearepidemiology of nutritional deficiencies will be investigated using blood biomarkers

Secondary

MeasureTime frameDescription
Assessment of inadequate vitamin B12 status1 yearepidemiology of vitamin B12 status will be investigated using serum vitamin B12 concentration
Assessment of inadequate folate status1 yearepidemiology of vitamin folate status will be investigated using serum folate concentration
Assessment of inadequate iron status1 yearepidemiology of vitamin folate status will be investigated using serum ferritin concentration
Assessment of inadequate vitamin D status1 yearepidemiology of vitamin D status will be investigated using serum 25-OH-vitamin D concentration
Assessment of dermal thickness1 yearepidemiology of dermal thickness will be measured using 20 MHz ultrasonography in micrometers
Assessment of dermal density1 yearepidemiology of dermal density will be measured using 20 MHz ultrasonography as an intensity score 0-100
Assessment of skin elasticity1 yearepidemiology of skin elasticity will be measured using Cortex DermaLab elasticity measurement
Assessment of body composition1 yearepidemiology 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.

Other

MeasureTime frameDescription
Body mass index (BMI) epidemiology of dietary intake of nutrients and fibre will be investigated from food records [g/day]1 yearWeight and height will be combined to report BMI in kg/m\^2 and providing insights into prevalence of overweight/obesity
Muscle strength1 yearMuscle strength will be measured as grip strength using dynamometer
Physical activity1 yearepidemiology of physical activity levels will be investigated using International Physical Activity Questionnaire (IPAQ) - Short Form

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026