NCT06951932 · RECRUITING

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

This trial is testing whether medium-chain triglycerides (MCTs) added to a Mediterranean diet can slow cognitive decline in people recently diagnosed with mild cognitive impairment. It compares that diet against a standard Mediterranean diet using extra virgin olive oil. This is a Phase NA trial, meaning it is a practical comparison study rather than early drug safety testing. The outcome being measured is how cognition changes over time.

You may qualify if

  • 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.

You're excluded if

  • 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

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2025-05-04

View full record on ClinicalTrials.gov

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