Alzheimer DiseaseORIVA2NCT04559828
Attenuation of Inflammatory Processes Associated With Alzheimer's Disease After Consumption of Pomace Olive Oil.
A study testing Experimental meal in people with Alzheimer Disease, run by National Research Council, Spain at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Experimental meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jun 2020to 28 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals.
- Subjects will be recruited after a complete biochemical and haematological analysis yields results within normal limits
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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:
- To obtain and characterize human TRL obtained after the intake of olive pomace oil.
- 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:
- 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.
- Isolation and characterization of human TRL. 2.1. General determinations in blood serum. 2.2. Characterization of TRL.
- Microglial activation in cells treated with human TRL. 3.1. Assays in cell cultures. 3.2. Analytical determinations. 3.3. Data processing and reporting.
- Conditions
- Alzheimer Disease
- Being tested
- Experimental meal
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental mealOther
Two dietary oils will be administrated as part of a single experimental meal, for the present is a postprandial phase study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Experimental meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postprandial (6 hours)
Secondary outcomes (1)
Redox markers
Concentrations of the redox markers reactivo oxygen species and total and reduced glutathione in BV2 cells treated with TRL obtained after the intake of pomace olive oil or high-oleic sunflower oil.
Measured: Postprandial (6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start10 Jun 2020
- Primary completion31 Oct 2020
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Council, Spain
- Sponsor type
- Other government
- Collaborators
- Hospitales Universitarios Virgen del Rocío
- Responsible party
- Principal investigator, Javier Sánchez Perona, National Research Council, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559828
- Sponsor's protocol ID
- 20191185 ORIVA
- Acronym
- ORIVA2
- Status last verified
- Aug 2021
- First submitted
- 9 Sep 2020
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attenuation of Inflammatory Processes Associated With Alzheimer's Disease After Consumption of Pomace Olive Oil.
- ClinicalTrials.gov ID
- NCT04559828
- Acronym / sponsor ID
- ORIVA2 / 20191185 ORIVA
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Research Council, SpainOther government
- Collaborators
- Hospitales Universitarios Virgen del Rocío
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- To obtain and characterize human TRL obtained after the intake of olive pomace oil.
- 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:
- 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.
- Isolation and characterization of human TRL. 2.1. General determinations in blood serum. 2.2. Characterization of TRL.
- Microglial activation in cells treated with human TRL. 3.1. Assays in cell cultures. 3.2. Analytical determinations. 3.3. Data processing and reporting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pomace olive oil | Active comparator | Other: Experimental meal50 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. |
| High-oleic sunflower oil | Active comparator | Other: Experimental meal50 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. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy individuals.
- Subjects will be recruited after a complete biochemical and haematological analysis yields results within normal limits
Key exclusion criteria (6 listed)
- Digestive or metabolic conditions.
- Overweight or obesity.
- Intolerance to food components or ingredients.
- Any condition affecting lipid metabolism.
- Any inflammatory condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental mealTwo dietary oils will be administrated as part of a single experimental meal, for the present is a postprandial phase study. | Other | High-oleic sunflower oil, Pomace olive oil |
Primary outcome
Inflammation markers
Time frame: Postprandial (6 hours)
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.
1 secondary outcome
Redox markers
Time frame: Postprandial (6 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental meal in people with Alzheimer Disease, run by National Research Council, Spain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammation markers (time frame: Postprandial (6 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.