Neuroprotective Effects of Oleanolic Acid and Erythrodiol in Prodromal Alzheimer's Disease

ConditionsAlzheimer s Disease Prodromal Alzheimer's Disease

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age50-80

SponsorSpanish National Research Council

About this trial

Alzheimer's disease begins many years before memory problems become obvious. People in the early ("prodromal") stage have memory complaints but are still independent in daily life. At present there is no treatment that prevents this stage from progressing to dementia.

Olive oil contains two natural compounds, oleanolic acid and erythrodiol. Earlier work by this research team suggests that these compounds may reduce inflammation and oxidative stress and may improve the way the body handles sugars and fats, processes that are also altered in Alzheimer's disease.

This study will test whether consuming olive oils that contain these compounds delays the progression from prodromal Alzheimer's disease to dementia.

A total of 120 adults aged 50 to 80 years with prodromal Alzheimer's disease will take part at three public hospitals in southern Spain. Participants will be assigned by chance to one of three groups and will consume 55 mL per day of one of three oils for 12 months: olive oil enriched with oleanolic acid, pomace olive oil (which naturally contains both compounds), or a standard commercial olive oil with very low levels of these compounds. Neither the participants nor the staff assessing them will know which oil each person is receiving.

Participants will attend study visits at the start of the study and after 6 and 12 months. At these visits they will complete memory and thinking tests, a physical and nutritional assessment, and blood and urine tests.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Oleanolic acid-enriched olive oil
Dietary supplement
Olive oil enriched with oleanolic acid (600 mg/kg), 55 mL/day for 12 months, consumed preferably raw and distributed across the three main meals.
Pomace olive oil
Dietary supplement
Commercial pomace olive oil, naturally containing oleanolic acid (180 mg/kg) and erythrodiol (670 mg/kg), 55 mL/day for 12 months, consumed preferably raw and distributed across the three main meals.
Commercial olive oil 0.4 degrees
Dietary supplement
Commercial olive oil 0.4°, with the same fatty acid composition but a very low content of minor bioactive components, 55 mL/day for 12 months, consumed preferably raw and distributed across the three main meals.

Treatment groups

120 Participants

are divided into 3 treatment groups

Group A: OA-enriched Olive OilExperimental treatment 1 intervention

Group B: Pomace Olive OilExperimental treatment 1 intervention

Group C: Control Olive OilPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Conversion from prodromal Alzheimer's disease to dementia

Proportion of participants converting to dementia, defined as a change in the Clinical Dementia Rating Global Score (CDR-GS) from 0.5 at baseline to 1 or higher. The CDR-GS ranges from 0 to 3, with higher scores indicating greater dementia severity

Time frame

Baseline to 12-months

Secondary outcomes

Change in Clinical Dementia Rating Sum of Boxes (CDR-SB)

CDR-SB total score ranges from 0 to 18, with higher scores indicating more severe cognitive impairment.

Time frame

Baseline to 12-months

Change in Mini-Mental State Examination (MMSE) score

MMSE total score ranges from 0 to 30, with higher scores indicating better global cognitive performance

Time frame

Baseline to 12-months

Change in Mild Behavioral Impairment Checklist (MBI-C) score

MBI-C assesses behavioral and psychological symptoms; higher scores indicate more severe symptoms

Time frame

Baseline to 12-months

Change in Functional Activities Questionnaire (FAQ) score

FAQ total score ranges from 0 to 30, with higher scores indicating greater functional impairment

Time frame

Baseline to 12-months

Other outcomes

Change in lipid metabolism biomarkers

Serum concentrations of total triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol, apolipoprotein A1 and apolipoprotein B

Time frame

Baseline, 6 months and 12 months

Change in glucose metabolism and insulin sensitivity biomarkers

Plasma glucose, insulin, glycated hemoglobin (HbA1c), HOMA-IR index and Quantitative Insulin Sensitivity Check Index (QUICKI)

Time frame

Baseline, 6 months and 12 months

Change in plasma lipid classes

Cholesterol esters, triglycerides, diglycerides, free cholesterol, monoglycerides, phospholipids and ceramides determined by HPLC-MS.

Time frame

Baseline and 12 months

Change in oxidative stress markers

Reduced and oxidized glutathione (GSH, GSSG), Nrf2 levels, activities of superoxide dismutase, catalase and heme oxygenase-1, reactive oxygen species production and malondialdehyde.

Time frame

Baseline, 6 months and 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Spanish National Research Council

Lead sponsor

Instituto de la Grasa

Sponsor institution

Valme University Hospital

Collaborator

Universidad de Granada

Collaborator

Maimónides Biomedical Research Institute of Córdoba

Collaborator

Hospital Universitario Reina Sofia de Cordoba

Collaborator

Universidad Pablo de Olavide

Collaborator

Source ClinicalTrials.gov

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