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

NCT04559828 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-09-01

No results posted yet for this study

Summary

Alzheimer's disease (AD) is the most common cause of dementia and its prevalence will multiply in the coming years, so it is urgent to establish preventive and therapeutic measures. AD it is characterized by cerebrovascular and parenchymal accumulation of protein deposits enriched in amyloid-beta (Aβ) as a consequence of alterations of the blood-brain barrier. More than 60% of plasma Aβ is associated with triglyceride-rich lipoproteins (TRL), being higher in subjects with AD. Microglia act as resident macrophages and play a crucial role in most neuropathologies, since it is activated after homeostasis impairment in the brain, and surrounds amyloid plaques in patients with AD. As a result of microglial activation, a large number of pro-inflammatory markers are released, mediated by alterations in the redox state, through the generation of ROS by the complex NADPH oxidase.

In a previous study, the investigators demonstrated in BV-2 cells that artificial TRL are capable of activating microglia and trigger an inflammatory process. In addition, the investigators showed that some of lipophilic minor components of pomace olive oil simultaneously modulate oxidative stress and the inflammatory response in microglia. The investigators suggested that these results should be replicated in humans after consumption of pomace olive oil.

Therefore, in the present study we formulate the hypothesis that human TRL are capable of activating microglia and that such activation can be attenuated when those particles are generated after consumption of pomace olive oil. The results of the study would lay the foundation for the start of clinical trials demonstrating the effect of pomace oil in reducing the risk of development and progression of AD.

Conditions

  • Alzheimer Disease

Interventions

OTHER

Experimental meal

Two dietary oils will be administrated as part of a single experimental meal, for the present is a postprandial phase study.

Sponsors & Collaborators

  • Hospitales Universitarios Virgen del Rocío

    collaborator OTHER

  • National Research Council, Spain

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
26 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-10
Primary Completion
2020-10-31
Completion
2021-07-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04559828 on ClinicalTrials.gov