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

NCT04559828 | Completed

• 1 other identifier: 20191185 ORIVA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Inflammation markers

  Release of proinflammatory markers TNF-α, IL-6 and IL-1β by BV2 cells treated with TRL obtained after the intake of pomace olive oil or high-oleic sunflower oil.

  Postprandial (6 hours)

Secondary Outcomes (1)

• Redox markers

  Postprandial (6 hours)

Study Arms (2)

Pomace olive oil

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.

Other: Experimental meal

High-oleic sunflower oil

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.

Other: Experimental meal

Interventions

Experimental meal OTHER

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

High-oleic sunflower oil; Pomace olive oil

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Digestive or metabolic conditions.
• Overweight or obesity.
• Intolerance to food components or ingredients.
• Any condition affecting lipid metabolism.
• Any inflammatory condition.
• Habitual drug intake of any kind.

Sponsors & Collaborators

• National Research Council, Spain: lead
• Hospitales Universitarios Virgen del Rocío: collaborator

Study Sites (1)

Instituto de la Grasa (IG-CSIC)

Seville, 41012, Spain

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tenured Scientist

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 23, 2020
• Study Start: June 10, 2020
• Primary Completion: October 31, 2020
• Study Completion: July 28, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)