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

NCT06951932 | Recruiting

• 1 other identifier: ASO.MedI.23.02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment (MCI)

Keywords

Montreal Cognitive Assessment; medium-chain triglycerides

Outcome Measures

Primary Outcomes (1)

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

  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).

  6 months after baseline

Secondary Outcomes (2)

• Positive effect of MCT intake on sleep quality

  Baseline and 6 months after baseline

• Evaluation of quality of life

  Baseline, 3 months after baseline and 6 months after baseline

Study Arms (2)

Mediterranean-type food regimen using extra virgin olive oil

ACTIVE COMPARATOR

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

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

Mediterranean-type diet with MCT supplementation

EXPERIMENTAL

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

Dietary Supplement: Mediterranean-type diet with MCT supplementation

Interventions

Mediterranean-type diet with MCT supplementation DIETARY_SUPPLEMENT

The treatment arm will follow a Mediterranean diet supplemented by daily intake of MCT (30 mL)

Mediterranean-type diet with MCT supplementation

Mediterranean-type food regimen using extra virgin olive oil OTHER

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

Mediterranean-type food regimen using extra virgin olive oil

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 may not qualify 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

Sponsors & Collaborators

• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: lead
• Dr. Schär AG / SPA: collaborator

Study Sites (1)

Clinical Trial Center

Alessandria, Piedmont, 15121, Italy

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Prof. Luigi Mario Castello

CONTACT

0131206893; luigi.castello@ospedale.al.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a nonpharmacological dietary supplement interventional study, controlled, randomized with two parallel arms

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: April 30, 2025
• Study Start: July 3, 2024
• Primary Completion: July 3, 2025
• Study Completion: November 3, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)