About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 85 years;
Diagnosis of MCI;
Disease duration of less than 24 months from symptom onset;
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);
Disqualifiers
Patients on total or supplemental enteral nutrition
Severe dysphagia
Patients with glycated hemoglobin > 8%
Patients on insulin therapy
Trial design
Parallel
Treatments tested in this trial
Mediterranean-type diet with MCT supplementation
Dietary supplementThe treatment arm will follow a Mediterranean diet supplemented by daily intake of MCT (30 mL)
Mediterranean-type food regimen using extra virgin olive oil
Other interventionThe arm will follow a Mediterranean diet with an indication to take extra virgin olive oil as the main fat in the diet daily
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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.
Evaluation of quality of life
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).
Sponsors and contacts
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Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Lead sponsor
Dr. Schär AG / SPA
Collaborator