Challenges in Achieving Adequate Dietary Status of Women

NCT06745817 | Enrolling By Invitation

• 2 other identifiers: KEP-4-14/2024L3-50125
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

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.

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

Keywords

dietary intake; nutritional status; micronutrients

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Assessment of inadequate vitamin D status

  1 year

• Assessment of inadequate vitamin B12 status

  1 year

• Assessment of inadequate folate status

  1 year

• Assessment of inadequate iron status

  1 year

• Assessment of body composition

  1 year

Other Outcomes (3)

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

  1 year

• Physical activity

  1 year

• Muscle strength

  1 year

Study Arms (2)

Part 1 sample

Adult women (20-49 years) with different dietary habits

Diagnostic Test: Screening questionnaire

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: Assessement of nutritional status; Diagnostic Test: Dermis density and thickness; Diagnostic Test: Skin elasticity; Diagnostic Test: Body composition measurement; Diagnostic Test: Screening questionnaire

Interventions

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)

Part 2 sample

Dermis density and thickness DIAGNOSTIC_TEST

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

Part 2 sample

Skin elasticity DIAGNOSTIC_TEST

Skin elasticity will be measured using Cortex DermaLab elasticity probe.

Part 2 sample

Body composition measurement DIAGNOSTIC_TEST

Body composition will be measured using Biostat Multiscan 5000.

Part 2 sample

Screening questionnaire DIAGNOSTIC_TEST

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

Part 1 sample; Part 2 sample

Eligibility Criteria

• Age: 20 Years - 49 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Age: 20 to 49 years
• Gender: female
• Agrees to participate in the study (has signed a consent form)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Institute of Nutrition, Slovenia (Nutris): lead
• National Institute of Public Health, Slovenia: collaborator
• VIST - Faculty of Applied Sciences: collaborator

Study Sites (3)

National Institute of Public Health, Slovenia

Ljubljana, 1000, Slovenia

Location

Nutrition Institute, Ljubljana

Ljubljana, 1000, Slovenia

Location

VIST Fakulteta za aplikativne vede Zmitek

Ljubljana, 1000, Slovenia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be destroyed after analysis.

MeSH Terms

Conditions

Vitamin D Deficiency; Vitamin B 12 Deficiency; Folic Acid Deficiency; Anemia, Iron-Deficiency; Motor Activity

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Vitamin B Deficiency; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Behavior

Study Officials

• Katja Zmitek, PhD

  Nutrition Institute, Ljubljana

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 20, 2024
• Study Start: January 6, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SL (3)