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Clinical Trials in Italy / NCT06951932
Recruiting Not applicable

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

NCT06951932 · tracked via the Priya Life Science Italy tracker
Sponsor
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Phase
Not applicable
Started
2024-07-03
Last updated
2025-05-04

Condition(s) studied

Mild Cognitive Impairment (MCI)

Investigational drug(s) / intervention(s)

Mediterranean-type diet with MCT supplementationMediterranean-type food regimen using extra virgin olive oil

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Effect of medium-chain triglycerides (MCT) intake on cognitive impairment — 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).

Trial sites (1)

FacilityCityRegionStatus
Clinical Trial Center Alessandria Piedmont Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06951932 on ClinicalTrials.gov ↗ ← All trials in Italy