Mild Cognitive Impairment (MCI)
Conditions
Keywords
Olive oil, Cognitive function, Cerebrovascular function, MCI
Brief summary
The goal of this clinical trial is to determine whether the extra-virgin olive oil (EVOO) phenolic dietary supplement can improve memory function and modulate biomarkers among individuals with mild cognitive impairment (MCI). The main questions it aims to answer are: * Does dietary supplementation with EVOO phenolics improve cognitive function? * What would be the effect of the EVOO dietary supplement on other MCI-related biomarkers, including vascular function and biological pathways? Researchers will compare the EVOO dietary supplements with a placebo (a look-alike substance that contains no EVOO phenolics) Participants will: * Take EVOO dietary supplements or a placebo daily for 6 months * Visit the study site during the 6-month study for screening and testing.
Interventions
DIETARY_SUPPLEMENTEVOO-phenolics dietary supplement
EVOO phenolic dietary supplement which is standardized to contain10 mg of EVOO total phenolics
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
Augusta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* CDR (Clinical Dementia Rating) score of 0.5 OR MoCA (Montreal Cognitive Assessment) score of 18-25.
Exclusion criteria
* History or presence of vascular disease that may affect cognitive function * History or presence of stroke within the past 1 year * Recent transient ischemic attack (TIA) within the past 180 days * History of severe, clinically significant CNS trauma * History of intracranial tumor * History or presence of kidney disease (eGFR \<60 mL/min/1.73m2) * Presence of a pacemaker * Presence of metal in the body * Allergic to the MRI contrast agent "Multihance" * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebrovascular function | At baseline and end of treatment (6 months) | To assess the effect of extra virgin olive oil (EVOO) phenolic dietary supplements on blood barin barrier function using Dynamic Contrast-Enhanced MRI (DCE-MRI) |
| Cerebrovascular blood flow | At baseline and end of treament (6 months) | To assess the effect of extra virgin olive oil (EVOO) phenolic dietary supplements on cerebrovascular blood flow using Near Infrared Spectroscopy. |
| Cognitive function | At baseline and end of treament (6 months) | To assess the effect of extra virgin olive oil (EVOO) phenolic dietary supplements on cognitive function, the Clinical Dementia Rating (CDR) and the National Institutes of Health (NIH) Toolbox Cognition Battery will be used. CDR and NIH Toolbox cognitive tests will be combined to report the overall effect of the intervention on changes in cognitive function. A CDR score of 0.5 indicates mild cognitive impairment, and a score of 3 indicates dementia. Those with a CDR score of 0 indicate normal cognitive function. For the NIH Toolbox tests, the Total Cognition Composite score is used, with 70 or lower indicating impaired cognition and 130 and above indicating superior cognitive ability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood biomarkers | At baseline and end of treatmnet (6 months) | Assess concentrations of Aβ40, Aβ42, tau, and p-tau181 using highly sensitive commercially available ELISA kits. All these biomarkers will be assessed in concentration units of ng/ml, where their decrease could indicate efficacy. |
| Proteomics | At baseline and end of treatmnet (6 months) | To assess the effect of extra virgin olive oil (EVOO) phenolic dietary supplements on changes in blood proteins linked to pathways associated with Alzheimer's disease. |
| Metabolomics | At baseline and end of treatment (6 months) | To assess the effect of extra virgin olive oil (EVOO) phenolic dietary supplements on changes in blood metabolites and lipids linked to pathways associated with Alzheimer's disease. |
Countries
United States
Contacts
CONTACTAmal Kaddoumi, PhD
CONTACTRyan Harris, PhD
PRINCIPAL_INVESTIGATORAmal Kaddoumi, PhD
Augusta University
Outcome results
None listed