ORIVA2Attenuation of Inflammatory Processes Associated With Alzheimer's Disease After Consumption of Pomace Olive Oil.
Experimental meal
Alzheimer Disease+6
+ Mental Disorders
+ Brain Diseases
Prevention Study
Summary
Study start date: June 10, 2020
Actual date on which the first participant was enrolled.In a previous study, the investigators demonstrated that triglyceride-rich lipoproteins (TRL), which transport dietary lipid components, are able of activating microglia, which could be associated with the state of neuroinflammation in patients of Alzheimer's disease. In addition, the investigators also demonstrated that some of the minor fat-soluble components of olive pomace oil simultaneously modulate oxidative stress and the inflammatory response in microglia, so that these components could have the ability to protect the brain from microglial overactivation when transported in TRL. In that study, the investigators used artificial TRL that were manufactured ad-hoc in the laboratory, in order to be able to test the effect of the compounds both individually and together. Now is the time to consolidate the results using human TRL, obtained after the consumption of olive pomace oil. The investigators expect that the results of this study will reveal that the intake of olive pomace oil can prevent the release of inflammatory markers caused by the overactivation of microglia, which could be associated to a reduction in the risk of development and progression of Alzheimer's disease. Objectives and design To test this hypothesis, two specific objectives will be addressed: 1. To obtain and characterize human TRL obtained after the intake of olive pomace oil. 2. To evaluate the mitigating effect of the microglial activation by TRL obtained after the intake of olive pomace oil. The study has been designed as a randomized and crossover trial in the postprandial phase in healthy subjects, which will be divided into two groups to which a pomace oil and high-oleic sunflower oil will be administered. Activities The specific objectives set out in the project will be addressed through the execution of the activities that are detailed below: 1. Selection of volunteers and administration of olive pomace oil. 1.1. Obtaining and characterizing the experimental oils. 1.2. Recruitment and selection of volunteers. 1.3. Clinical trial in the postprandial phase. 2. Isolation and characterization of human TRL. 2.1. General determinations in blood serum. 2.2. Characterization of TRL. 3. Microglial activation in cells treated with human TRL. 3.1. Assays in cell cultures. 3.2. Analytical determinations. 3.3. Data processing and reporting.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 26 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location