Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT05389618
Status:
UNKNOWN
Last Update Posted:
2023-06-22
First Post:
2022-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dietary Challenges in the Population of Nursing Homes' Residents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D014806', 'term': 'Vitamin B 12 Deficiency'}, {'id': 'D005494', 'term': 'Folic Acid Deficiency'}, {'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}, {'id': 'D011488', 'term': 'Protein Deficiency'}, {'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014804', 'term': 'Vitamin B Deficiency'}, {'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': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D001835', 'term': 'Body Weight'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Blood samples will be freezed for possible further analyses on markers related with nutrition \\& health'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-20', 'studyFirstSubmitDate': '2022-05-19', 'studyFirstSubmitQcDate': '2022-05-24', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Nutritional intakes', 'timeFrame': '1 year', 'description': 'epidemiology of dietary intake of nutrients and fibre will be investigated from food records \\[g/day\\]'}, {'measure': 'Body mass index', 'timeFrame': '1 year', 'description': 'Weight and height will be combined to report BMI in kg/m\\^2 and providing insights into prevalence of overweight/obesity'}, {'measure': 'Prevalence of sarcopenia', 'timeFrame': '1 years', 'description': 'epidemiology of sarcopenia will be investigated using EWGSOP2 (European Working Group on Sarcopenia in Older People 2) criteria and estimated ASM (apendicular skeletal muscle mass)'}], 'primaryOutcomes': [{'measure': 'Assessment of protein intake', 'timeFrame': '1 year', 'description': 'epidemiology of protein intake will be investigated from food records \\[g/day\\]'}, {'measure': 'Assessment of energy intake', 'timeFrame': '1 year', 'description': 'epidemiology of energy intake will be investigated from food records \\[kJ/day\\]'}], 'secondaryOutcomes': [{'measure': 'Assessment of inadequate vitamin D status', 'timeFrame': '1 year', 'description': 'epidemiology of vitamin D status will be investigated using serum 25-OH-vitamin D concentration'}, {'measure': 'Assessment of inadequate folate status', 'timeFrame': '1 year', 'description': 'epidemiology of folate status will be investigated using serum folate concentration'}, {'measure': 'Assessment of inadequate vitamin B12 status', 'timeFrame': '1 year', 'description': 'epidemiology of vitamin B12 status will be investigated using serum vitamin B12 concentration'}, {'measure': 'Assessment of inadequate iron status', 'timeFrame': '1 year', 'description': 'epidemiology of iron status will be investigated using serum ferritin concentration'}, {'measure': 'Assessment of anemia', 'timeFrame': '1 year', 'description': 'epidemiology of anemia will be investigated using serum haemoglobin concentration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dietary intake', 'nutritional status', 'micronutrients', 'Slovenia', 'Europe'], 'conditions': ['Nutritional Status', 'Nutrient Deficiency', 'Micronutrient Deficiency', 'Vitamin D Deficiency', 'Vitamin B 12 Deficiency', 'Folic Acid Deficiency', 'Iron-deficiency', 'Protein Deficiency', 'Sarcopenia', 'Obesity', 'Diet']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://nutris.org/en/projects/nutricare-en', 'label': 'Project web site'}]}, 'descriptionModule': {'briefSummary': 'To obtain up-to-date data on nutritional status of older adults, a national dietary survey will be conducted in 2022/2023, providing data on the consumption of foods and enabling the assessment intakes of energy and specific nutrients. Participating subjects will be also screened for micronutrient status using blood biomarkers (focusing into vitamin D, folic acid, vitamin B12, and iron).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This observational study is conducted on randomly selected residents of 18 different nursing homes, located in all regions in Republic of Slovenia, using described inclusion/exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 65 years or older\n* Has been in the elderly care institution (nursing home) for at least 3 months before joining the study\n* Care category: I., II., III.A\n* The person can feed independently or with minimal help\n* Agrees to be included in the study (signed a statement of consent)\n\nExclusion Criteria:\n\n* The person has an acute illness\n* The person is a dialysis patient\n* Temporary special diet / fasting / gastrointestinal cleansing (i.e. due to (pre)planned examinations / procedures)\n* The person cannot be weighted by the usual weighing scale or chair weighing scale\n* Protégé of the day care center\n* Located in the red zone of the elderly care institution (nursing home) (COVID-19 measures)'}, 'identificationModule': {'nctId': 'NCT05389618', 'acronym': 'NUTRICARE', 'briefTitle': "Dietary Challenges in the Population of Nursing Homes' Residents", 'organization': {'class': 'OTHER', 'fullName': 'Institute of Nutrition, Slovenia (Nutris)'}, 'officialTitle': "Dietary Challenges in the Population of Nursing Homes' Residents in Slovenia", 'orgStudyIdInfo': {'id': 'Z3-3213'}, 'secondaryIdInfos': [{'id': 'KME 0120-531/2021/13', 'type': 'OTHER', 'domain': 'National Medical Ethics Committee (Slovenia)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Older adults 65-80 years', 'interventionNames': ['Other: Diagnostic Tests']}, {'label': 'Older adults above 80 years', 'interventionNames': ['Other: Diagnostic Tests']}], 'interventions': [{'name': 'Diagnostic Tests', 'type': 'OTHER', 'description': 'Assessment of socio-demographic parameters, anthropometric and body composition parameters, food intake (dietary recalls, food propensity questionnaire) and nutritional status (blood biomarkers)', 'armGroupLabels': ['Older adults 65-80 years', 'Older adults above 80 years']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Nutrition Institute, Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Živa Lavriša, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nutrition Institute, Ljubljana'}, {'name': 'Igor Pravst, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nutrition Institute, Ljubljana'}, {'name': 'Ivan Eržen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Institute of Public Health, Slovenia'}, {'name': 'Nadan Gregorič', 'role': 'STUDY_CHAIR', 'affiliation': 'University Medical Centre Ljubljana'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Nutrition, Slovenia (Nutris)', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Public Health, Slovenia', 'class': 'OTHER_GOV'}, {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, {'name': 'Slovenian Research Agency', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}