Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT06951932
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06951932
Study Brief:
Protocol Section:
NCT06951932