Status:
RECRUITING
Evaluation of the Impact of Medium-chain Fatty Acids in the Evolution of Newly Diagnosed Mild Cognitive Impairment
Lead Sponsor:
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Collaborating Sponsors:
Dr. Schär AG / SPA
Conditions:
Mild Cognitive Impairment (MCI)
Eligibility:
All Genders
18-85 years
Phase:
NA
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 on...
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 hypot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 3 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06951932
Start Date
July 3 2024
End Date
November 3 2025
Last Update
May 4 2025
Active Locations (1)
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1
Clinical Trial Center
Alessandria, Piedmont, Italy, 15121