Evaluation of the Impact of Medium-chain Fatty Acids in the Evolution of Newly Diagnosed Mild Cognitive Impairment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAzienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Mediterranean-type diet with MCT supplementation

    Dietary supplement

    The 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 intervention

    The 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

120 Participants
are divided into 2 treatment groups
Group A: Mediterranean-type food regimen using extra virgin olive oilActive comparator 1 intervention
Group B: Mediterranean-type diet with MCT supplementationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
6 months after baseline

Secondary outcomes

1

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.

Time frame
Baseline and 6 months after baseline
2

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).

Time frame
Baseline, 3 months after baseline and 6 months after baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.