Trials / Enrolling By Invitation
Enrolling By InvitationNCT06745817
Challenges in Achieving Adequate Dietary Status of Women
Challenges in Achieving Adequate Dietary Status of Women of Reproductive Age (NutriFem)
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Institute of Nutrition, Slovenia (Nutris) · Academic / Other
- Sex
- Female
- Age
- 20 Years – 49 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Nutritional Status
- Nutrient Deficiency
- Micronutrient Deficiency
- Vitamin D Deficiency
- Vitamin B 12 Deficiency
- Folic Acid Deficiency
- Iron-deficiency
- Diet
- Dermis Density
- Dermis Thickness
- Skin Elasticity
- Body Composition
- Physical Activity
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2025-01-06
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2024-12-20
- Last updated
- 2025-03-19
Locations
3 sites across 1 country: Slovenia
Source: ClinicalTrials.gov record NCT06745817. Inclusion in this directory is not an endorsement.