Assessing Treatment With High-phenolic EVOO Supplements for Neurovascular Activity
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: EVOO-phenolics dietary supplement, Placebo.
- Who it may be relevant to
- Registry conditions: Mild Cognitive Impairment (MCI). Basic parameters: 50 years — 70 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
- United States
- 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
Dietary Supplementation With EVOO Phenolics Prevents MCI Progression to Alzheimer's Disease
Overview
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 supplement EVOO-phenolics dietary supplement
EVOO phenolic dietary supplement which is standardized to contain10 mg of EVOO total phenolics - Dietary supplement Placebo
Placebo
Primary outcome measures
- Cerebrovascular function [Time frame: At baseline and end of treatment (6 months)]
- Cerebrovascular blood flow [Time frame: At baseline and end of treament (6 months)]
- Cognitive function [Time frame: At baseline and end of treament (6 months)]
Secondary outcome measures (3)
- Blood biomarkers [Time frame: At baseline and end of treatmnet (6 months)]
- Proteomics [Time frame: At baseline and end of treatmnet (6 months)]
- Metabolomics [Time frame: At baseline and end of treatment (6 months)]
Eligibility criteria
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
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
- Triple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Georgia prevention institute — Augusta
Identifiers
NCT: NCT07741773 · 2445297-2