Clinical trial NCT06951932: Evaluation of the Impact of Medium-chain Fatty Acids in the Evolution of Newly Diagnosed Mild Cognitive Impairment
Official title: Evaluation of the Impact of Medium-chain Fatty Acids in the Evolution of Newly Diagnosed Mild Cognitive Impairment: Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Keywords: Montreal Cognitive Assessment
medium-chain triglycerides
Lead sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Sponsor class: OTHER
Collaborators: name: Dr. Schär AG / SPA
First posted: 2025-04-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a nonpharmacological dietary supplement interventional study, controlled, randomized with two parallel arms
Primary purpose: TREATMENT

Brief 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.

Detailed description: Mild cognitive impairment (MCI) is considered the intermediate stage between the changes observed in physiological aging and dementia. The need to diagnose MCI at an early stage is driven by the hypothesis that therapeutic interventions may be more effective in the early stages of the disease. In addition, many studies have shown that sleep disturbances can affect neurodegeneration and be used as a marker of disease, manifesting before cognitive impairment itself. 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: 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 outcomes:
measure: Effect of medium-chain triglycerides (MCT) intake on cognitive impairment
timeFrame: 6 months after baseline
Secondary outcomes:
measure: Positive effect of MCT intake on sleep quality
timeFrame: Baseline and 6 months after baseline
measure: Evaluation of quality of life
timeFrame: Baseline, 3 months after baseline and 6 months after baseline
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Clinical Trial Center
state: Piedmont
Study officials:
References: