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

Summary

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.

Interventions

• 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

  The arm will follow a Mediterranean diet with an indication to take extra virgin olive oil as the main fat in the diet daily

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* 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);
* Ability to understand and sign informed consent.

Exclusion Criteria:

* Patients on total or supplemental enteral nutrition
* Severe dysphagia
* Patients with glycated hemoglobin \> 8%
* Patients on insulin therapy
* Patients with poor beta-cell function (e.g., pancreasectomy, acute and chronic pancreatitis)
* Patients with liver failure: MELD score \> 9
* 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)
* Metabolic disorders and/or enzyme disorders, dyslipidemia with total cholesterolemia \>300 mg/dl and/or triglyceridemia \>400 mg/dl)
* Acute inflammatory disease or ongoing or recent (within 30 days) infectious states
* Hypo- and hyperthyroidism not adequately compensated by treatment
* Heart failure (NYHA III-IV), unstable angina, recent (\<6 months) acute cardiovascular or cerebrovascular events
* Pregnancy or lactation
* Neurological disorders other than MCI, psychiatric disorders
* Nutrition and eating disorder
* Alcohol abuse
* Institutionalized patients
* Participation in experimental therapies in the 2 months prior to enrollment
* Allergy to MCT oil, nuts

Sites (1)

• Clinical Trial Center, Alessandria, Piedmont, Italy · RECRUITING