- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07442305
Assessing Dietary Intake of Selected Food Components Using Short Questionnaires (NutriPlant/FFQ)
Validation of Short Questionnaires for Assessing Dietary Intake of Selected Food Components
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Maša Hribar, PhD
- Phone Number: +386 590 68870
- Email: masa.hribar@nutris.org
Study Contact Backup
- Name: Liza Mohoric
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Study sample
Adults (18-65 years)
|
Screening questionnaire: assessment of socio-demographic parameters, use of food supplements, health status, dietary habits
Assessment of food intake (5x 24-h dietary recalls) and estimation of nutritional intakes
Dietary fibe intake assessed using KV-PV (Short questionnaire for the assessment of dietary fibre intake)
Iron intake using KV-Fe (Short questionnaire for the assessment of iron intake)
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nutritional intake using 24-h food recalls (5d-PD)
Time Frame: 1 week
|
Nutritional intake will be estimated using 24-h food recalls for 5 days (5d-PD)
|
1 week
|
|
Dietary fibre intake (KV-PV)
Time Frame: 6 weeks
|
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)
Time Frame: 6 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Laboratory assessment of iron status: S-ferritin
Time Frame: once during 6 weeks of the study
|
Laboratory assessment of iron status using blood analyses
|
once during 6 weeks of the study
|
|
Laboratory assessment of iron status: S-iron
Time Frame: once during 6 weeks of the study
|
Laboratory assessment of iron status using blood analyses
|
once during 6 weeks of the study
|
|
Laboratory assessment of iron status: hemoglobin
Time Frame: once during 6 weeks of the study
|
Laboratory assessment of iron status using blood analyses
|
once during 6 weeks of the study
|
|
Laboratory assessment of blood lipids: total cholesterol
Time Frame: once during 6 weeks of the study
|
laboratory assessment of lipid profile using blood analyses
|
once during 6 weeks of the study
|
|
Laboratory assessment of blood lipids: HDL cholesterol
Time Frame: once during 6 weeks of the study
|
laboratory assessment of lipid profile using blood analyses
|
once during 6 weeks of the study
|
|
Laboratory assessment of blood lipids: LDL cholesterol
Time Frame: once during 6 weeks of the study
|
laboratory assessment of lipid profile using blood analyses
|
once during 6 weeks of the study
|
|
Laboratory assessment of blood lipids: triglycerides
Time Frame: once during 6 weeks of the study
|
laboratory assessment of lipid profile using blood analyses
|
once during 6 weeks of the study
|
Collaborators and Investigators
Investigators
- Study Chair: Igor Pravst, PhD, Institute of Nutrition, Ljubljana, Slovenia
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEP-5-13/2025
- L7-50154 (Other Grant/Funding Number: Ministry of Agriculture, Forestry and Food)
- J3-70143 (Other Grant/Funding Number: Slovenian Research And Innovation Agency)
- P3-0395 (Other Identifier: Slovenian Research And Innovation Agency)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Iron-deficiency
-
Pennington Biomedical Research CenterCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency Anemia TreatmentUnited States
-
Tampere University HospitalTampere UniversityRecruitingIron Deficiency | Iron Deficiency Anaemia in Childbirth | Iron Status | Iron Deficiency in Pregnancy | Iron Deficiency Anemia in PregnancyFinland
-
King's CollegeCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency (Without Anemia)United States
-
Children's Hospital Los AngelesNational Institute of Neurological Disorders and Stroke (NINDS)RecruitingAnemia | Iron Deficiency Anemia | Anemia, Iron Deficiency | IDA - Iron Deficiency AnemiaUnited States
-
Antalya Training and Research HospitalCompletedIron Deficiency Anemia | Iron Deficiency Anemia TreatmentTurkey
-
Arrowhead Regional Medical CenterRecruitingIron Deficiency Anemia of PregnancyUnited States
-
CMH Multan Institute of Medical SciencesCompletedPregnancy | Iron Deficiency Anemia (IDA)Pakistan
-
University of MinnesotaNational Heart, Lung, and Blood Institute (NHLBI); Syracuse University; Liverpool... and other collaboratorsCompletedIron-deficiency | Iron-deficiency AnemiaGhana
-
Société des Produits Nestlé (SPN)CompletedIron-deficiency | Anemia | Iron Deficiency AnemiaPhilippines
-
Swiss Federal Institute of TechnologyUniversity of MalawiCompletedIron-deficiency | Iron Deficiency AnemiaMalawi, Switzerland
Clinical Trials on Screening questionnaire
-
Children's Hospitals and Clinics of MinnesotaCompletedFirearm Injury | Firearm Safety | Firearm OwnershipUnited States
-
University College, LondonMedical Research Council; Cancer Research UK; National Institute for Health Research... and other collaboratorsCompleted
-
Susanne WalitzaRecruitingSubstance Use DisordersSwitzerland
-
University Hospital, GrenobleClinique des Cèdres, EchirollesNot yet recruitingInflammatory Bowel Diseases | Crohn Disease | Spondylarthritis | Ulcerative Colitis | Spondylitis, AnkylosingFrance
-
University of OxfordUniversity College DublinRecruiting
-
Gazi UniversityCompleted
-
Markus J. ErnstCompletedMigraine | Tension-Type HeadacheSwitzerland
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingScreening Breast MRI in Patients Who Are BRCA Mutation CarriersUnited States
-
Great Ormond Street Hospital for Children NHS Foundation...WithdrawnDisordered EatingUnited Kingdom