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| Name | Class |
|---|---|
| Dr. Schär AG / SPA | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean-type food regimen using extra virgin olive oil | Active Comparator | 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 |
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| Mediterranean-type diet with MCT supplementation | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean-type diet with MCT supplementation | Dietary Supplement | The treatment arm will follow a Mediterranean diet supplemented by daily intake of MCT (30 mL) |
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| Measure | Description | Time Frame |
|---|---|---|
| Effect of medium-chain triglycerides (MCT) intake on cognitive impairment | 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). | 6 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Positive effect of MCT intake on sleep quality | Evaluate the positive effect of MCT intake on sleep quality in patients with MCI using the Pittsburgh and Epworth Scales, sleep quality rating scales. | Baseline and 6 months after baseline |
| Evaluation of quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Luigi Mario Castello | Contact | 0131206893 | luigi.castello@ospedale.al.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center | Recruiting | Alessandria | Piedmont | 15121 | Italy |
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This is a nonpharmacological dietary supplement interventional study, controlled, randomized with two parallel arms
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| Mediterranean-type food regimen using extra virgin olive oil | Other | The arm will follow a Mediterranean diet with an indication to take extra virgin olive oil as the main fat in the diet daily |
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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). |
| Baseline, 3 months after baseline and 6 months after baseline |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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