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

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Status: Enrolling

Conditions: Mild Cognitive Impairment (MCI)

Treatments: Dietary Supplement: Mediterranean-type diet with MCT supplementation; Other: Mediterranean-type food regimen using extra virgin olive oil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06951932

ASO.MedI.23.02

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Mediterranean-type food regimen using extra virgin olive oil

Active Comparator group

Description:

Patients with with first diagnosis of MCI referred to the S.C of Neurology and/or Geriatrics and/or Internal Medicine of the SS. Antonio e Biagio e Cesare Arrigo of Alessandria University Hospital, randomized into the control arm

Treatment:

Other: Mediterranean-type food regimen using extra virgin olive oil

Mediterranean-type diet with MCT supplementation

Experimental group

Description:

Patients with with first diagnosis of MCI referred to the S.C of Neurology and/or Geriatrics and/or Internal Medicine of the SS. Antonio e Biagio e Cesare Arrigo of Alessandria University Hospital, randomized into the experimental arm

Treatment:

Dietary Supplement: Mediterranean-type diet with MCT supplementation