Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
Study NCT ID:
NCT05661006
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2022-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ETOL-Elderly Study of the Efficiency of the Innovative Food Supplement in Elderly Adults
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': 'D011488', 'term': 'Protein Deficiency'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Subjects will be randomized on the first day of Visit 1 using simple randomisation using ratio 1:1 between test and placebo group.\n\nAfter the general subject's health is checked (vital signs), subjects will be assigned Subject Number, which will be pre-randomised to correspond with one of interventions (test group, placebo group).\n\nTo assure double blind approach, study products will be packed in neutral packaging, and pre-labelled with Subject Number (S-XXX) and instructions for use. Selected site will be provided enough product i.e. subject boxes with corresponding Subject Number to cover initially planned number of included subject."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This was a randomized, parallel, double-blind, placebo-controlled study included healthy elderly adults (age \\> 65 years) who tested study products. On screening visit, participants underwent measuring of body weight \\& height, and blood collection for measuring S-25-OH-VitD, S-VitB12, S-protein, S-albumin, S-CRP. Duration of study intervention for individual participant 56 ± 3 days, with one week pre-intervention monitoring of food intake (3x 24-h dietary records). On day 1 of the intervention period, participants were randomised in a 1:1 ratio.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-19', 'studyFirstSubmitDate': '2022-12-13', 'studyFirstSubmitQcDate': '2022-12-13', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum vitamin D levels will be determined', 'timeFrame': '56 days', 'description': 'Serum level of 25-OH-vitamin D will be measured before and after the intervention for each individual.'}], 'secondaryOutcomes': [{'measure': 'Change in dietary protein intake will be determined', 'timeFrame': '56 days', 'description': 'Dietary protein intake will be estimated before and after the intervention for each individual, using 3x24h food records.'}, {'measure': 'Change in serum vitamin B12 levels will be determined', 'timeFrame': '56 days', 'description': 'Serum level of vitamin B12 will be measured before and after the intervention for each individual.'}, {'measure': 'Malnutrition at baseline', 'timeFrame': 'baseline', 'description': 'Risks for malnutritition at baseline will be assessed using dietary records (3x24h food record: energy, protein and plasma concentration of 25-OH-D and vitamin B12.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitamin d Deficiency', 'Vitamin B 12 Deficiency', 'Protein Deficiency']}, 'descriptionModule': {'briefSummary': 'The aim of this pilot study is to conduct a study on geriatric population in Slovenia (non-users of dietary supplements/medicines with vitamine D, vitamin B12 and protein) and assess deficiency of selected nutrients, and to investigate the efficiency of the innovative food supplement prototype in improving nutritional status of elderly adults.', 'detailedDescription': 'The main objective is to show that in the geriatric population regular use of investigation food supplement would improve nutritional status. The study should provide answers to the following main questions: (1) Is regular use of investigated product beneficial for improving serum vitamin D levels in elderly population? (2) Is regular use of investigated product beneficial for increasing daily protein intake in elderly population? (3) Is regular use of investigated product beneficial for improving vitamin B12 status in elderly population?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\n* Subject Informed consent form (ICF) is singed\n* Aged at least 65 at the time of the signature of ICF\n* A body mass index lower than 32 kg/m2\n* Willing to avoid a consumption supplementation with protein, vitamin D and vitamin B12 during the study\n* Willing to follow all study procedures, including attending all site visits (including blood sampling) and keeping a diary for using the product and six 24-hour dietary records (3x pre-intervention, 3x during last week of the intervention)\n\nExclusion criteria:\n\n* Medical treatment with Vitamin D and/or Vitamin B12\n* Supplementation with protein, vitamin D and/or vitamin B12 during least 2 months\n* Known drug and/or alcohol abuse\n* Known lactose/gluten intolerances/food allergies\n* Inadequate veins (in the opinion of the investigator) or known contraindication for venous blood withdrawal\n* Have chronic bowel disease (ulcerative colitis, Chron's disease, stomach or duodenal ulcer, chronic inflammation of the stomach or duodenum)\n* Have acute gastrointestinal infection with vomiting and / or diarrhea\n* Have planned general anaesthesia or colonoscopy at the time of the study\n* Have malabsorption syndrome\n* Less than 5 years after treatment for gastrointestinal cancer (stomach, duodenum or colon)\n* Have stomach or bowel resection\n* Do not have neat and functional teeth\n* Take regular or occasional laxative products\n* Use antacids (Rupurut / Rutacid / Talcit)\n* Mental incapacity that precludes adequate understanding or cooperation\n* Participation in another investigational study"}, 'identificationModule': {'nctId': 'NCT05661006', 'acronym': 'ETOL-Elderly', 'briefTitle': 'ETOL-Elderly Study of the Efficiency of the Innovative Food Supplement in Elderly Adults', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Nutrition, Slovenia (Nutris)'}, 'officialTitle': 'Study of the Efficiency of the Innovative Food Supplement in Improving Nutritional Status of Elderly Adults', 'orgStudyIdInfo': {'id': '2020/1-ET-SK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Subjects taking control product', 'interventionNames': ['Dietary Supplement: Use of placebo food supplement']}, {'type': 'EXPERIMENTAL', 'label': 'Active group', 'description': 'Subjects taking active product', 'interventionNames': ['Dietary Supplement: Use of food supplement']}], 'interventions': [{'name': 'Use of food supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'On day 1 subjects start with intervention on prearranged day. First dosage of test product is consumed during day 1 between regular meals (not as meal substitute).\n\nIn the following days: continuation of consumption of test product once per day until end of the intervention. Subjects are recording daily consumption of the product. Intervention diet recording during last week of intervention (days 49-56): 3x24h dietary records (two days during weekday, one weekend day).\n\nIntervention end on day 56 ±3 (fasted condition):\n\nMeasuring S-25-OH-VitD, S-VitB12, S-protein, S-albumin, S-CRP Measuring body weight \\& height Collecting data regarding the palatability of the product', 'armGroupLabels': ['Active group']}, {'name': 'Use of placebo food supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'On day 1 subjects start with intervention on prearranged day. First dosage of test product is consumed during day 1 between regular meals (not as meal substitute). In the following days: continuation of consumption of test product once per day until end', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trzin', 'country': 'Slovenia', 'facility': 'VIZERA', 'geoPoint': {'lat': 46.13637, 'lon': 14.56167}}], 'overallOfficials': [{'name': 'Mojca Miholič, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Researcher'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Nutrition, Slovenia (Nutris)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vizera d.o.o.', 'class': 'INDUSTRY'}, {'name': 'Frutarom Etol d.o.o.', 'class': 'INDUSTRY'}, {'name': 'European Regional Development Fund', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}