Nutritional StatusNutriPlant/FFQNCT07442305
Assessing Dietary Intake of Selected Food Components Using Short Questionnaires
An observational study of Nutritional Status and Iron-deficiency, run by Institute of Nutrition, Slovenia (Nutris).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Status, Iron-deficiency, Diet
- What is being tested?
- 5d-PD: Nutritional intakes using 24-h food recalls, KV-PV: Dietary fibre intake and KV-Fe: Iron intake
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: About 50 subjects, aged 18-65 years, with expected drop-out rate about 10%. Invitations through institute web page and social media.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Liza Mohoric contact
About this study
Official title: Validation of Short Questionnaires for Assessing Dietary Intake of Selected Food Components
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.
Read the detailed description
Based on previous research conducted in Slovenia and across Europe, it can be concluded that notable proportion of the Slovenian population does not meet the recommended intake of dietary fibre. At the same time, there are important population groups at increased risk of inadequate iron intake, particularly women of reproductive age. Both nutrients have significant implications for health and represent an important public health challenge that requires appropriate monitoring of dietary intake at the population level.
With the aim of providing a simple and reliable assessment of dietary fibre and iron intake in research, clinical, and public health settings, two short questionnaires adapted to the Slovenian context have been developed. The questionnaire for assessing dietary fibre intake (KV-PV) is based on the FiberScreen questionnaire developed by Dutch researchers and was adapted to the Slovenian dietary pattern using data from the SI.Menu study. The questionnaire for assessing iron intake (KV-Fe) is based on the validated IRONQ-FFQ and adapted for the Slovenian population.
Despite the content adaptation of both questionnaires to the Slovenian context, further validation is required before their practical application, in order to assess the reliability and usability of these tools for evaluating dietary fibre and iron intake in Slovenia.
The objectives of the project are to:
Determine dietary fibre intake as assessed by the KV-PV questionnaire. Determine iron intake as assessed by the KV-Fe questionnaire. Determine dietary fibre intake using a 5-day dietary record. Determine iron intake using a 5-day dietary record. Compare dietary fibre intake assessed by the KV-PV questionnaire with the 5-day dietary record and evaluate the reliability of the KV-PV.
Compare iron intake assessed by the KV-Fe questionnaire with the 5-day dietary record and evaluate the reliability of the KV-Fe.
Compare the results of two KV-PV questionnaires completed with a 6-week interval.
Compare the results of two KV-Fe questionnaires completed with a 6-week interval.
Examine potential correlations between the results of the tested questionnaires and selected biochemical indicators in participants who voluntarily opt for blood sampling.
- Conditions
- Nutritional Status, Iron-deficiency, Diet
- Being tested
- 5d-PD: Nutritional intakes using 24-h food recalls, KV-PV: Dietary fibre intake, KV-Fe: Iron intake, Screening questionnaire, Blood biomarkets
- Keywords
- dietary intake, nutritional status, micronutrients, iron, ffq, food recall
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5d-PD: Nutritional intakes using 24-h food recallsDiagnostic test
Assessment of food intake (5x 24-h dietary recalls) and estimation of nutritional intakes
KV-PV: Dietary fibre intakeDiagnostic test
Dietary fibe intake assessed using KV-PV (Short questionnaire for the assessment of dietary fibre intake)
KV-Fe: Iron intakeDiagnostic test
Iron intake using KV-Fe (Short questionnaire for the assessment of iron intake)
Screening questionnaireDiagnostic test
Screening questionnaire: assessment of socio-demographic parameters, use of food supplements, health status, dietary habits
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 group | Role | What they receive |
|---|---|---|
| Study sample | Adults (18-65 years) Receives: Diagnostic Test: 5d-PD: Nutritional intakes using 24-h food recalls; Diagnostic Test: KV-PV: Dietary fibre intake; Diagnostic Test: KV-Fe: Iron intake; Diagnostic Test: Screening questionnaire; Diagnostic Test: Blood biomarkets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional intake using 24-h food recalls (5d-PD)
Nutritional intake will be estimated using 24-h food recalls for 5 days (5d-PD)
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Nutrition, Slovenia (Nutris)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Igor Pravst, PhD, Study chair, Institute of Nutrition, Ljubljana, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442305
- Sponsor's protocol ID
- KEP-5-13/2025
- Other IDs
- L7-50154, L7-50154, J3-70143, P3-0395
- Acronym
- NutriPlant/FFQ
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No