Clinical Trial Center
Alessandria, Piedmont, 15121, Italy
Location status: Recruiting
NCT Number: NCT06951932
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Not applicable
Alessandria, Piedmont, 15121, Italy
Location status: Recruiting
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The treatment arm will follow a Mediterranean diet supplemented by daily intake of MCT (30 mL)
The arm will follow a Mediterranean diet with an indication to take extra virgin olive oil as the main fat in the diet daily
Time frame: 6 months after baseline
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).
Time frame: Baseline and 6 months after baseline
Evaluate the positive effect of MCT intake on sleep quality in patients with MCI using the Pittsburgh and Epworth Scales, sleep quality rating scales.
Time frame: Baseline, 3 months after baseline and 6 months after baseline
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).
Contact information is provided by the study sponsor or research team.
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Other
Evaluation of the Impact of Medium-chain Fatty Acids in the Evolution of Newly Diagnosed Mild Cognitive Impairment: Prospective Randomized Controlled Trial
Acronym: MCI-MCT
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