Completed

ORIVA2Attenuation of Inflammatory Processes Associated With Alzheimer's Disease After Consumption of Pomace Olive Oil.

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What is being tested

Experimental meal

Other
Who is being recruted

Alzheimer Disease+6

+ Mental Disorders

+ Brain Diseases

From 18 to 26 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: June 2020
See protocol details

Summary

Principal SponsorNational Research Council, Spain
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleAttenuation of Inflammatory Processes Associated With Alzheimer's Disease After Consumption of Pomace Olive Oil.
NCT04559828
Principal SponsorNational Research Council, Spain
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Alzheimer DiseaseMental DisordersBrain DiseasesCentral Nervous System DiseasesDementiaNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersTauopathies

Criteria

2 inclusion criteria required to participate
Healthy individuals.

Subjects will be recruited after a complete biochemical and haematological analysis yields results within normal limits

6 exclusion criteria prevent from participating
Digestive or metabolic conditions.

Overweight or obesity.

Intolerance to food components or ingredients.

Any condition affecting lipid metabolism.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
50 g of high-sunflower oil will be administered in a single dose together with a breakfast composed of 3 slices of whole-grain bread, 5 g of tomato pureé and 200 ml of milk.

Group II

Active Comparator
50 g of pomace olive oil will be administered in a single dose together with a breakfast composed of 3 slices of whole-grain bread, 5 g of tomato pureé and 200 ml of milk.

Study 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

Suspended

Instituto de la Grasa (IG-CSIC)

Seville, SpainOpen Instituto de la Grasa (IG-CSIC) in Google Maps
CompletedOne Study Center