Impact of Medium-chain Fatty Acids on Mild Cognitive Impairment

Evaluation of the Impact of Medium-chain Fatty Acids in the Evolution of Newly Diagnosed Mild Cognitive Impairment: Prospective Randomized Controlled Trial

This study is testing whether adding medium-chain fatty acids to a Mediterranean diet can help improve thinking skills and sleep quality in people with mild cognitive impairment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria (Academic / other)
• Locations: 1 site (Alessandria, Piedmont)
• Trial ID: NCT06951932 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of medium-chain triglycerides (MCTs) on patients diagnosed with mild cognitive impairment (MCI). It aims to determine if a Mediterranean-type diet supplemented with MCTs can enhance cognitive function and improve sleep quality in individuals with MCI. The study will include participants aged 18 to 85 who have been diagnosed with MCI within the last 24 months and will monitor their progress over a specified period. The approach is based on existing literature suggesting that MCTs may have antioxidant properties and cognitive benefits.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with a diagnosis of mild cognitive impairment and a disease duration of less than 24 months.

Not a fit: Patients with severe metabolic disorders, liver failure, or those on insulin therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new dietary intervention to improve cognitive function and quality of life for patients with mild cognitive impairment.

How similar studies have performed: Previous studies have shown positive effects of omega-3 fatty acids on MCI, suggesting that dietary interventions may be beneficial, although the specific use of MCTs is less established.

Eligibility criteria

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

Where this trial is running

Alessandria, Piedmont

• Clinical Trial Center — Alessandria, Piedmont, Italy (Recruiting)

Study contacts

• Study coordinator: Prof. Luigi Mario Castello

Conditions Mild Cognitive Impairment; Montreal Cognitive Assessment; medium-chain triglycerides