NCT07442305

Brief Summary

The aim of the study is to validate short questionnaires for assessing dietary intake of selected food components, with a focus on dietary fibre and iron. Two internationally developed short questionnaires (FiberScreen \[for dietary fibre\] and IRONQ-FFQ \[for iron\]) were adapted to the Slovenian context and will be compared with the standard 24-hour dietary recall method.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
17mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Mar 2026Dec 2027

First Submitted

Initial submission to the registry

February 9, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 9, 2026

Last Update Submit

February 27, 2026

Conditions

Iron-deficiencyDietNutritional Status

Keywords

dietary intakenutritional statusmicronutrientsironffqfood recall

Outcome Measures

Primary Outcomes (3)

  • Nutritional intake using 24-h food recalls (5d-PD)

    Nutritional intake will be estimated using 24-h food recalls for 5 days (5d-PD)

    1 week

  • Dietary fibre intake (KV-PV)

    Dietary fibe intake will be assessed using KV-PV (Short questionnaire for the assessment of dietary fibre intake) in beginning of the study and after about 6 weeks.

    6 weeks

  • Iron intake (KV-Fe)

    Iron intake will be assesed using KV-Fe (Short questionnaire for the assessment of iron intake) n beginning of the study and after about 6 weeks.

    6 weeks

Other Outcomes (7)

  • Laboratory assessment of iron status: S-ferritin

    once during 6 weeks of the study

  • Laboratory assessment of iron status: S-iron

    once during 6 weeks of the study

  • Laboratory assessment of iron status: hemoglobin

    once during 6 weeks of the study

  • +4 more other outcomes

Study Arms (1)

Study sample

Adults (18-65 years)

Diagnostic Test: 5d-PD: Nutritional intakes using 24-h food recallsDiagnostic Test: KV-PV: Dietary fibre intakeDiagnostic Test: KV-Fe: Iron intakeDiagnostic Test: Screening questionnaireDiagnostic Test: Blood biomarkets

Interventions

5d-PD: Nutritional intakes using 24-h food recallsDIAGNOSTIC_TEST

Assessment of food intake (5x 24-h dietary recalls) and estimation of nutritional intakes

Study sample
KV-PV: Dietary fibre intakeDIAGNOSTIC_TEST

Dietary fibe intake assessed using KV-PV (Short questionnaire for the assessment of dietary fibre intake)

Study sample
KV-Fe: Iron intakeDIAGNOSTIC_TEST

Iron intake using KV-Fe (Short questionnaire for the assessment of iron intake)

Study sample
Screening questionnaireDIAGNOSTIC_TEST

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

Study sample
Blood biomarketsDIAGNOSTIC_TEST

Subjects we be provided with option for laboratory assessment of iron status (ferritin, serum iron, and hemoglobin) and a basic lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides).

Study sample

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

About 50 subjects, aged 18-65 years, with expected drop-out rate about 10%. Invitations through institute web page and social media.

You may qualify if:

  • Willingness to participate in the study.
  • Signed Statement of Informed and Voluntary Consent to Participate in the Study.
  • Age between 18 and 65 years at the time of enrolment in the study.
  • Willingness to comply with all study procedures and to keep a dietary record in accordance with the provided instructions.

You may not qualify if:

  • Pregnancy or breastfeeding.
  • Specific dietary practices followed by a small proportion of the population (veganism, LCHF, calorie-restricted diets; note: vegetarians are not excluded).
  • Diets prescribed by medical professionals.
  • Mental incapacity that prevents adequate understanding or participation.
  • Reasons for excluding a participant during the study:
  • Inability to participate in the study
  • Wishes to discontinue participation
  • Incomplete data provided

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be destroyed after analysis.

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Igor Pravst, PhD

    Institute of Nutrition, Ljubljana, Slovenia

    STUDY CHAIR

Central Study Contacts

Maša Hribar, PhD

CONTACT

+386 590 68870masa.hribar@nutris.org

Liza Mohoric

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2026

First Posted

March 2, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share