Challenges in Achieving Adequate Dietary Status of Women

• Conditions: Nutritional Status; Nutrient Deficiency; Micronutrient Deficiency; Vitamin D Deficiency; Vitamin B 12 Deficiency; Folic Acid Deficiency; Iron-deficiency; Diet; Dermis Density; Dermis Thickness

• Registration Number: NCT06745817
• Lead Sponsor: Nutrition Institute, Slovenia

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.

Study Timeline

• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-17
• Study First Posted: 2024-12-20
• Study Start: 2025-01-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of nutrient intake	1 year	epidemiology of nutrients intake will be investigated from food records (dietary recalls, food propensity questionaires) \[g/day\]
Assessment of nutritional deficiencies	1 year	epidemiology of nutritional deficiencies will be investigated using blood biomarkers

Secondary Outcome Measures

Name	Time	Method
Assessment of inadequate vitamin D status	1 year	epidemiology of vitamin D status will be investigated using serum 25-OH-vitamin D concentration
Assessment of inadequate vitamin B12 status	1 year	epidemiology of vitamin B12 status will be investigated using serum vitamin B12 concentration
Assessment of inadequate folate status	1 year	epidemiology of vitamin folate status will be investigated using serum folate concentration
Assessment of inadequate iron status	1 year	epidemiology of vitamin folate status will be investigated using serum ferritin concentration
Assessment of body composition	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.
Assessment of dermal thickness	1 year	epidemiology of dermal thickness will be measured using 20 MHz ultrasonography in micrometers
Assessment of dermal density	1 year	epidemiology of dermal density will be measured using 20 MHz ultrasonography as an intensity score 0-100
Assessment of skin elasticity	1 year	epidemiology of skin elasticity will be measured using Cortex DermaLab elasticity measurement

Trial Locations

Locations (3)

National Institute of Public Health, Slovenia; 🇸🇮 Ljubljana, Slovenia

Nutrition Institute, Ljubljana; 🇸🇮 Ljubljana, Slovenia

VIST Fakulteta za aplikativne vede Zmitek; 🇸🇮 Ljubljana, Slovenia