Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-02 @ 2:08 AM
Study NCT ID:
NCT06951932
Status:
RECRUITING
Last Update Posted:
2025-05-04
First Post:
2025-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Impact of Medium-chain Fatty Acids in the Evolution of Newly Diagnosed Mild Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a nonpharmacological dietary supplement interventional study, controlled, randomized with two parallel arms'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2025-04-23', 'studyFirstSubmitQcDate': '2025-04-23', 'lastUpdatePostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of medium-chain triglycerides (MCT) intake on cognitive impairment', 'timeFrame': '6 months after baseline', 'description': 'Evaluate the effect of medium-chain triglycerides (MCT) intake on cognitive decline in patients with first diagnosis of MCI through the use of the Montreal Cognitive Assessment (MoCA), that includes a series of tests of visuospatial/executive functions, naming, attention, language, abstraction, delayed recall, and orientation for a total score of 30 (best cognitive status).'}], 'secondaryOutcomes': [{'measure': 'Positive effect of MCT intake on sleep quality', 'timeFrame': 'Baseline and 6 months after baseline', 'description': 'Evaluate the positive effect of MCT intake on sleep quality in patients with MCI using the Pittsburgh and Epworth Scales, sleep quality rating scales.'}, {'measure': 'Evaluation of quality of life', 'timeFrame': 'Baseline, 3 months after baseline and 6 months after baseline', 'description': "Assessing quality of life through the QoL AD score (Quality of life in Alzheimer's Disease), characterized by 15 items that can be answered by choosing from four options that are scored from 1 (poor) to 4 (excellent). The total score ranges from 13 (worst quality of life) to 52 (best quality of life)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Montreal Cognitive Assessment', 'medium-chain triglycerides'], 'conditions': ['Mild Cognitive Impairment (MCI)']}, 'descriptionModule': {'briefSummary': "Mild cognitive impairment (MCI) is considered the intermediate stage between the changes observed in physiological aging and dementia. Currently, there is no drug therapy, and available drugs offer only minimal benefit on symptoms, only partially slowing the course of the condition. Studies in the literature have investigated the role of omega-3 fatty acids in MCI, and when administered over a period of six months, they appear to improve clinical condition and mood. In addition, medium-chain triglycerides (MCTs) appear to exert an antioxidant function, enhance cognitive ability in patients with MCI or Alzheimer's, and promote deep sleep state.", 'detailedDescription': "Mild cognitive impairment (MCI) is considered the intermediate stage between the changes observed in physiological aging and dementia. The need to diagnose MCI at an early stage is driven by the hypothesis that therapeutic interventions may be more effective in the early stages of the disease. In addition, many studies have shown that sleep disturbances can affect neurodegeneration and be used as a marker of disease, manifesting before cognitive impairment itself. Currently, there is no drug therapy, and available drugs offer only minimal benefit on symptoms, only partially slowing the course of the condition. Studies in the literature have investigated the role of omega-3 fatty acids in MCI, and when administered over a period of six months, they appear to improve clinical condition and mood. In addition, medium-chain triglycerides (MCTs) appear to exert an antioxidant function, enhance cognitive ability in patients with MCI or Alzheimer's, and promote deep sleep state"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 85 years;\n* Diagnosis of MCI;\n* Disease duration of less than 24 months from symptom onset;\n* Absence of malnutrition (diagnosed according to the NRS 2002 screening test) and with oral intakes sufficient to cover energy requirements (calculated by the Harris-Benedict formula, adjusted for activity factor and pathology);\n* Ability to understand and sign informed consent.\n\nExclusion Criteria:\n\n* Patients on total or supplemental enteral nutrition\n* Severe dysphagia\n* Patients with glycated hemoglobin \\> 8%\n* Patients on insulin therapy\n* Patients with poor beta-cell function (e.g., pancreasectomy, acute and chronic pancreatitis)\n* Patients with liver failure: MELD score \\> 9\n* Malnutrition (diagnosed according to the NRS 2002 screening test) and with per os intakes \\< 60% of energy requirements (calculated using the Harris-Benedict formula, corrected for activity factor and pathology)\n* Metabolic disorders and/or enzyme disorders, dyslipidemia with total cholesterolemia \\>300 mg/dl and/or triglyceridemia \\>400 mg/dl)\n* Acute inflammatory disease or ongoing or recent (within 30 days) infectious states\n* Hypo- and hyperthyroidism not adequately compensated by treatment\n* Heart failure (NYHA III-IV), unstable angina, recent (\\<6 months) acute cardiovascular or cerebrovascular events\n* Pregnancy or lactation\n* Neurological disorders other than MCI, psychiatric disorders\n* Nutrition and eating disorder\n* Alcohol abuse\n* Institutionalized patients\n* Participation in experimental therapies in the 2 months prior to enrollment\n* Allergy to MCT oil, nuts'}, 'identificationModule': {'nctId': 'NCT06951932', 'acronym': 'MCI-MCT', 'briefTitle': 'Evaluation of the Impact of Medium-chain Fatty Acids in the Evolution of Newly Diagnosed Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria'}, 'officialTitle': 'Evaluation of the Impact of Medium-chain Fatty Acids in the Evolution of Newly Diagnosed Mild Cognitive Impairment: Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ASO.MedI.23.02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mediterranean-type food regimen using extra virgin olive oil', 'description': 'Patients with with first diagnosis of MCI referred to the S.C of Neurology and/or Geriatrics and/or Internal Medicine of the SS. Antonio e Biagio e Cesare Arrigo of Alessandria University Hospital, randomized into the control arm', 'interventionNames': ['Other: Mediterranean-type food regimen using extra virgin olive oil']}, {'type': 'EXPERIMENTAL', 'label': 'Mediterranean-type diet with MCT supplementation', 'description': 'Patients with with first diagnosis of MCI referred to the S.C of Neurology and/or Geriatrics and/or Internal Medicine of the SS. Antonio e Biagio e Cesare Arrigo of Alessandria University Hospital, randomized into the experimental arm', 'interventionNames': ['Dietary Supplement: Mediterranean-type diet with MCT supplementation']}], 'interventions': [{'name': 'Mediterranean-type diet with MCT supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The treatment arm will follow a Mediterranean diet supplemented by daily intake of MCT (30 mL)', 'armGroupLabels': ['Mediterranean-type diet with MCT supplementation']}, {'name': 'Mediterranean-type food regimen using extra virgin olive oil', 'type': 'OTHER', 'description': 'The arm will follow a Mediterranean diet with an indication to take extra virgin olive oil as the main fat in the diet daily', 'armGroupLabels': ['Mediterranean-type food regimen using extra virgin olive oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15121', 'city': 'Alessandria', 'state': 'Piedmont', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Clinical Trial Center', 'role': 'CONTACT', 'email': 'clinicaltrialcenter@ospedale.al.it', 'phone': '0131206893'}], 'facility': 'Clinical Trial Center', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}], 'centralContacts': [{'name': 'Prof. Luigi Mario Castello', 'role': 'CONTACT', 'email': 'luigi.castello@ospedale.al.it', 'phone': '0131206893'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dr. Schär AG / SPA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}