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NCT Number: NCT06951932

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center

Alessandria, Piedmont, 15121, Italy

Location status: Recruiting

Location contact

Clinical Trial Center

CONTACT

[email protected]

0131206893

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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

Primary outcomes

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

    Time frame: 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).

Secondary outcomes

  1. Positive effect of MCT intake on sleep quality

    Time frame: Baseline and 6 months after baseline

    Evaluate the positive effect of MCT intake on sleep quality in patients with MCI using the Pittsburgh and Epworth Scales, sleep quality rating scales.

  2. Evaluation of quality of life

    Time frame: Baseline, 3 months after baseline and 6 months after baseline

    Assessing quality of life through the QoL AD score (Quality of life in Alzheimer's Disease), characterized by 15 items that can be answered by choosing from four options that are scored from 1 (poor) to 4 (excellent). The total score ranges from 13 (worst quality of life) to 52 (best quality of life).

Study contacts

Contact information is provided by the study sponsor or research team.

Prof. Luigi Mario Castello

CONTACT

[email protected]

0131206893

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Dr. Schär AG / SPA

Registry information

Official study title

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

Acronym: MCI-MCT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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