Evaluation of the Impact of Medium-chain Fatty Acids in the Evolution of Newly Diagnosed Mild Cognitive Impairment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mediterranean-type diet with MCT supplementation, Mediterranean-type food regimen using extra virgin olive oil.
- Who it may be relevant to
- Registry conditions: Mild Cognitive Impairment (MCI). Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Impact of Medium-chain Fatty Acids in the Evolution of Newly Diagnosed Mild Cognitive Impairment: Prospective Randomized Controlled Trial
Overview
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
Interventions
- Dietary supplement Mediterranean-type diet with MCT supplementation
The treatment arm will follow a Mediterranean diet supplemented by daily intake of MCT (30 mL) - Other Mediterranean-type food regimen using extra virgin olive oil
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 outcome measures
- Effect of medium-chain triglycerides (MCT) intake on cognitive impairment [Time frame: 6 months after baseline]
Secondary outcome measures (2)
- Positive effect of MCT intake on sleep quality [Time frame: Baseline and 6 months after baseline]
- Evaluation of quality of life [Time frame: Baseline, 3 months after baseline and 6 months after baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Clinical Trial Center — Alessandria
Identifiers
NCT: NCT06951932 · ASO.MedI.23.02