Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:24 PM
Study NCT ID:
NCT07442305
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Dietary Intake of Selected Food Components Using Short Questionnaires
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples will be destroyed after analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Laboratory assessment of iron status: S-ferritin', 'timeFrame': 'once during 6 weeks of the study', 'description': 'Laboratory assessment of iron status using blood analyses'}, {'measure': 'Laboratory assessment of iron status: S-iron', 'timeFrame': 'once during 6 weeks of the study', 'description': 'Laboratory assessment of iron status using blood analyses'}, {'measure': 'Laboratory assessment of iron status: hemoglobin', 'timeFrame': 'once during 6 weeks of the study', 'description': 'Laboratory assessment of iron status using blood analyses'}, {'measure': 'Laboratory assessment of blood lipids: total cholesterol', 'timeFrame': 'once during 6 weeks of the study', 'description': 'laboratory assessment of lipid profile using blood analyses'}, {'measure': 'Laboratory assessment of blood lipids: HDL cholesterol', 'timeFrame': 'once during 6 weeks of the study', 'description': 'laboratory assessment of lipid profile using blood analyses'}, {'measure': 'Laboratory assessment of blood lipids: LDL cholesterol', 'timeFrame': 'once during 6 weeks of the study', 'description': 'laboratory assessment of lipid profile using blood analyses'}, {'measure': 'Laboratory assessment of blood lipids: triglycerides', 'timeFrame': 'once during 6 weeks of the study', 'description': 'laboratory assessment of lipid profile using blood analyses'}], 'primaryOutcomes': [{'measure': 'Nutritional intake using 24-h food recalls (5d-PD)', 'timeFrame': '1 week', 'description': 'Nutritional intake will be estimated using 24-h food recalls for 5 days (5d-PD)'}, {'measure': 'Dietary fibre intake (KV-PV)', 'timeFrame': '6 weeks', 'description': '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.'}, {'measure': 'Iron intake (KV-Fe)', 'timeFrame': '6 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dietary intake', 'nutritional status', 'micronutrients', 'iron', 'ffq', 'food recall'], 'conditions': ['Nutritional Status', 'Iron-deficiency', 'Diet']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nWith 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.\n\nDespite 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.\n\nThe objectives of the project are to:\n\nDetermine 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.\n\nCompare iron intake assessed by the KV-Fe questionnaire with the 5-day dietary record and evaluate the reliability of the KV-Fe.\n\nCompare the results of two KV-PV questionnaires completed with a 6-week interval.\n\nCompare the results of two KV-Fe questionnaires completed with a 6-week interval.\n\nExamine potential correlations between the results of the tested questionnaires and selected biochemical indicators in participants who voluntarily opt for blood sampling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'About 50 subjects, aged 18-65 years, with expected drop-out rate about 10%. Invitations through institute web page and social media.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Willingness to participate in the study.\n* Signed Statement of Informed and Voluntary Consent to Participate in the Study.\n* Age between 18 and 65 years at the time of enrolment in the study.\n* Willingness to comply with all study procedures and to keep a dietary record in accordance with the provided instructions.\n\nExclusion criteria:\n\n* Pregnancy or breastfeeding.\n* Specific dietary practices followed by a small proportion of the population (veganism, LCHF, calorie-restricted diets; note: vegetarians are not excluded).\n* Diets prescribed by medical professionals.\n* Mental incapacity that prevents adequate understanding or participation.\n\nReasons for excluding a participant during the study:\n\n* Inability to participate in the study\n* Wishes to discontinue participation\n* Incomplete data provided'}, 'identificationModule': {'nctId': 'NCT07442305', 'acronym': 'NutriPlant/FFQ', 'briefTitle': 'Assessing Dietary Intake of Selected Food Components Using Short Questionnaires', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Nutrition, Slovenia (Nutris)'}, 'officialTitle': 'Validation of Short Questionnaires for Assessing Dietary Intake of Selected Food Components', 'orgStudyIdInfo': {'id': 'KEP-5-13/2025'}, 'secondaryIdInfos': [{'id': 'L7-50154', 'type': 'OTHER_GRANT', 'domain': 'Slovenian Research And Innovation Agency'}, {'id': 'L7-50154', 'type': 'OTHER_GRANT', 'domain': 'Ministry of Agriculture, Forestry and Food'}, {'id': 'J3-70143', 'type': 'OTHER_GRANT', 'domain': 'Slovenian Research And Innovation Agency'}, {'id': 'P3-0395', 'type': 'OTHER', 'domain': 'Slovenian Research And Innovation Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study sample', 'description': 'Adults (18-65 years)', 'interventionNames': ['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']}], 'interventions': [{'name': '5d-PD: Nutritional intakes using 24-h food recalls', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assessment of food intake (5x 24-h dietary recalls) and estimation of nutritional intakes', 'armGroupLabels': ['Study sample']}, {'name': 'KV-PV: Dietary fibre intake', 'type': 'DIAGNOSTIC_TEST', 'description': 'Dietary fibe intake assessed using KV-PV (Short questionnaire for the assessment of dietary fibre intake)', 'armGroupLabels': ['Study sample']}, {'name': 'KV-Fe: Iron intake', 'type': 'DIAGNOSTIC_TEST', 'description': 'Iron intake using KV-Fe (Short questionnaire for the assessment of iron intake)', 'armGroupLabels': ['Study sample']}, {'name': 'Screening questionnaire', 'type': 'DIAGNOSTIC_TEST', 'description': 'Screening questionnaire: assessment of socio-demographic parameters, use of food supplements, health status, dietary habits', 'armGroupLabels': ['Study sample']}, {'name': 'Blood biomarkets', 'type': 'DIAGNOSTIC_TEST', 'description': '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).', 'armGroupLabels': ['Study sample']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Maša Hribar, PhD', 'role': 'CONTACT', 'email': 'masa.hribar@nutris.org', 'phone': '+386 590 68870'}, {'name': 'Liza Mohoric', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Igor Pravst, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Nutrition, Ljubljana, Slovenia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Nutrition, Slovenia (Nutris)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}