Challenges in Achieving Adequate Dietary Status of Women (NutriFem)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Physical Activity; Iron-deficiency; Vitamin D Deficiency; Nutritional Status; Body Composition; Vitamin B 12 Deficiency; Folic Acid Deficiency; Diet; Skin Elasticity; Nutrient Deficiency; Micronutrient Deficiency; Dermis Density; Dermis Thickness
• Intervention / Treatment: Diagnostic test: Screening questionnaire; Diagnostic test: Assessement of nutritional status; Diagnostic test: Dermis density and thickness; Diagnostic test: Skin elasticity; Diagnostic test: Body composition measurement

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Nutrition Institute, Ljubljana
  • Ljubljana, Slovenia, 1000
    • National Institute of Public Health, Slovenia
  • Ljubljana, Slovenia, 1000
    • VIST Fakulteta za aplikativne vede Zmitek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Part 1 sample; Adult women (20-49 years) with different dietary habits	Diagnostic test: Screening questionnaire; Screening questionnaire: assessment of socio-demographic parameters, use of food supplements, health status, dietary habits
Part 2 sample; Adult women (20-49 years) with different dietary habits invited from Part 1, including also subsamples of vegans, vegetarians, omnivores	Diagnostic test: Screening questionnaire; Screening questionnaire: assessment of socio-demographic parameters, use of food supplements, health status, dietary habits; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index (BMI) epidemiology of dietary intake of nutrients and fibre will be investigated from food records [g/day]	Weight and height will be combined to report BMI in kg/m^2 and providing insights into prevalence of overweight/obesity	1 year
Physical activity	epidemiology of physical activity levels will be investigated using International Physical Activity Questionnaire (IPAQ) - Short Form	1 year
Muscle strength	Muscle strength will be measured as grip strength using dynamometer	1 year

Collaborators and Investigators

• Sponsor: Nutrition Institute, Slovenia
• Collaborators: National Institute of Public Health, Slovenia; VIST - Faculty of Applied Sciences
• Investigators: Study Chair: Katja Zmitek, PhD, Nutrition Institute, Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: nutritional status; micronutrients; dietary intake
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Iron Metabolism Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin B Deficiency; Iron Deficiencies; Vitamin D Deficiency; Folic Acid Deficiency; Vitamin B 12 Deficiency
• Other Study ID Numbers: KEP-4-14/2024; L3-50125 (Other Grant/Funding Number: Ministry of Health, Republic of Slovenia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No