Effect of the Intake of Corbella Extra Virgin Olive Oil on the Microbiota-gut-brain Axis in Healthy Adults (HEVOOC) (HEVOOC)

March 26, 2025 updated by: Rosa M Lamuela-Raventós, University of Barcelona

Development of Oil with Healthy Properties Based on Corbella Olive Variety (HEVOOC)

The consumption of the improved extra virgin olive oil (EVOO) of the Corbella variety could have a beneficial effect on the microbiota-intestine-brain axis (MGBA). Olive oil contains polyphenols that are not present in other oils, notably oleocanthal and oleacein, which behave similarly to ibuprofen and have a protective effect on some neurodegenerative diseases. The polyphenols of the oil present prebiotic characteristics, at the level of the intestinal microbiota, which metabolizes them forming bioactive metabolites that can have a modulating effect on the MGBA, improving brain health. In this study, the researchers seek to identify the benefits of the consumption of Corbella variety EVOO on MGBA in healthy participants. The overall benefit of the study would be to achieve knowledge that would allow its future applicability to prevent and improve certain diseases and in general contribute to optimal health.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To evaluate possible effects on MGBA, a randomized, controlled, crossover nutritional trial will be conducted. Thirty healthy adult participants (between 18 and 35 years of age, with 50% male and 50% female) will be included according to the estimated sample size. Participants will consume a daily amount of 0.7 g Corbella EVOO/kg body weight plus their normal diet (experimental intervention) and 0.7 g refined olive oil (ROO)/kg body weight plus their normal diet (control intervention) for 1 month. Biological samples (plasma, peripheral blood mononuclear cells, serum, 24-hour urine, feces and saliva) will be obtained at baseline and at the end of each trial arm.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Rosa M Lamuela Raventós, PhD
  • Phone Number: +34-934020909
  • Email: lamuela@ub.edu

Study Locations

  • Spain
      • Barcelona, Spain, 08028
        • Department of Nutrition, Food Sciences and Gastronomy. School of Farmacy and Food Sciences. University of Barcelona.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adult with Body mass index (BMI) < 30 kg/m2
  • Signed informed consent

Exclusion Criteria:

  • Any chronic disease (e.g. cardiovascular disease, cancer or diabetes)
  • Mental disorders (e.g. depression, dementia, autism, etc.)
  • Cardiovascular alterations in cholesterol,triglycerides, glucose, etc.
  • Current smokers
  • Repeated use of antibiotics
  • Frequent use of corticoids, nonsteroidal anti-inflammatory drugs
  • Repeated use of vitamins
  • Volunteers with extreme eating habits (i.e. Atkins diet, very high protein diets, etc.)
  • Excessive alcohol consumption (>30 g/d for males and >20 g/d for females),
  • Pregnant, lactating, and postmenopausal women

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EXTRA VIRGIN (intervention / control)
After a 3-day run in period avoiding EVOO consumption, participants will consume a daily amount of 0.7 g EVOO / kg body weight in addition to their usual diet for 1 months. They will then have 4 weeks with their usual diet and another 3-day run in period before starting the control intervention, which consists of following their usual diet plus 0.7 g olive oil low of polyphenol (OOLP)/ kg body weight daily for one month.
Other: EXTRA VIRGIN OLIVE OIL
Participants will consume a daily amount of extra virgin olive oil. Can consume the oil either raw or cooked
Other: OLIVE OIL LOW POLYPHENOL
Participants will consume a daily amount of olive oil low polyphenol. Can consume the oil either raw or cooked
Experimental: LOW POLYPHENOL (control/intervention)
After a 3-day run-in period avoiding EVOO consumption, participants will consume a daily amount of 0.7 g of OOLP/ kg body weight in addition to their usual diet for 1 month. Then, they will have 4 weeks with their usual diet and another run in period of 3 days before starting the intervention which consists of following their usual diet plus 0.7 g of EVOO / kg body weight daily for one month.
Other: EXTRA VIRGIN OLIVE OIL
Participants will consume a daily amount of extra virgin olive oil. Can consume the oil either raw or cooked
Other: OLIVE OIL LOW POLYPHENOL
Participants will consume a daily amount of olive oil low polyphenol. Can consume the oil either raw or cooked

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in brain-derived neurotrophic factor (BDNF) after each intervention with EVOO and the control intervention.
Time Frame: Baseline and after completed each intervention (1 month)
Serum samples will be analysed for mature BDNF using a Mature BDNF Rapid ELISA kit.
Baseline and after completed each intervention (1 month)
Changes in the short-chain fatty acids in plasma and feces samples after each intervention with EVOO and the control intervention.
Time Frame: Baseline and after completed each intervention (1 month)
After acidifying the fecal samples with formic acid, a quantification of short-chain fatty acids will be performed using gas chromatography by direct injection according to previously described methodology (Zhao et al., 2006).
Baseline and after completed each intervention (1 month)
Changes in bile acids in plasma and feces samples after each intervention with EVOO and the control intervention.
Time Frame: Baseline and after completed each intervention (1 month)
Bile acids will be assayed using a validated liquid chromatography-mass spectrometry (LC-MS) method
Baseline and after completed each intervention (1 month)
Changes in cerebrovascular function after each intervention with EVOO and the control intervention.
Time Frame: Baseline and after completed each intervention (1 month)
Cerebrovascular function will be measured using functional magnetic resonance imaging (FMRI), a non-invasive method for assessing brain activity. FMRI maps blood oxygenation levels in the brain and estimates changes in the blood flow that depends on metabolic function and is correlated with specific brain region activities
Baseline and after completed each intervention (1 month)
Changes in the gut microbiota after each intervention with EVOO and the control intervention.
Time Frame: Baseline and after completed each intervention (1 month)
Fecal samples will be collected by the volunteers using a system for easy self-collection and stabilization of microbial DNA for gut microbiome profiling (OMNIgene - GUT). The extraction of genomic DNA from fecal samples will be carried out utilizing the DNeasy Power Kit. Subsequently, microbial profiling will employ 16 S ribosomal RNA (rRNA) sequencing to investigate microbial communities, with a specific focus on bacterial phylogeny and taxonomy.
Baseline and after completed each intervention (1 month)
Changes in the polyphenols and their metabolites after each intervention with EVOO and the control intervention.
Time Frame: Baseline and after completed each intervention (1 month)
Polyphenols and their metabolites derived from intestinal gut microbiota will be identified and quantified in human plasma, urine, feces, and saliva samples using high performance liquid chromatography (HPLC) - Linear Trap Quadrupole (LTQ) Orbitrap-MS/MS and HPLC-MS/MS techniques.
Baseline and after completed each intervention (1 month)
Changes in carotenoids and their metabolites after each intervention with EVOO and the control intervention.
Time Frame: Baseline and after completed each intervention (1 month)
Carotenoids and their metabolites derived from intestinal gut microbiota will be identified and quantified in human plasma, urine, feces, and saliva samples using high performance liquid chromatography (HPLC) - Linear Trap Quadrupole (LTQ) Orbitrap-MS/MS and HPLC-MS/MS techniques.
Baseline and after completed each intervention (1 month)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in body weight after each intervention with EVOO and the control intervention.
Time Frame: Baseline and after completed each intervention (1 month)
Body weight in kilograms (kg)
Baseline and after completed each intervention (1 month)
Changes in body mass index (BMI) after each intervention with EVOO and the control intervention.
Time Frame: Baseline and after completed each intervention (1 month)
BMI will be calculated as body weight (kg) divided by height (m). Weight and height will be combined to report BMI in kg/m^2
Baseline and after completed each intervention (1 month)
Changes in hip circumference after each intervention with EVOO and the control intervention.
Time Frame: Baseline and after completed each intervention (1 month)
It will be measured with a tape-measure in triplicate, in centimeters (cm)
Baseline and after completed each intervention (1 month)
Changes in waist circumference after each intervention with EVOO and the control intervention.
Time Frame: Baseline and after completed each intervention (1 month)
It will be measured with a tape-measure in triplicate, in centimeters (cm)
Baseline and after completed each intervention (1 month)
Changes in body composition after each intervention with EVOO and the control intervention.
Time Frame: Baseline and after completed each intervention (1 month)
Body fat percentage will be measured using a bioelectrical impedance analysis monitor.
Baseline and after completed each intervention (1 month)
Changes in blood pressure after each intervention with EVOO and the control intervention.
Time Frame: Baseline and after completed each intervention (1 month)
Diastolic and systolic blood pressure will be measured by a blood pressure monitor in triplicate.
Baseline and after completed each intervention (1 month)
Changes in heart rate after each intervention with EVOO and the control intervention.
Time Frame: Baseline and after completed each intervention (1 month)
Heart rate (bpm) will be measured with an automatic monitor in triplicate.
Baseline and after completed each intervention (1 month)
Changes in lipidic profile after each intervention with EVOO and the control intervention.
Time Frame: Baseline and after completed each intervention (1 month)
Total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mg/dL) will be measured by molecular absorption spectrometry.
Baseline and after completed each intervention (1 month)
Changes in liver function after each intervention with EVOO and the control intervention.
Time Frame: Baseline and after completed each intervention (1 month)
Alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP) and albumin will be assayed by immunoenzymatic methods.
Baseline and after completed each intervention (1 month)
Changes in glucose after each intervention with EVOO and the control intervention.
Time Frame: Baseline and after completed each intervention (1 month)
Glucose (mg/dL) will be measured by molecular absorption spectrometry.
Baseline and after completed each intervention (1 month)
Changes in inflammatory biomarkers after each intervention with EVOO and the control intervention.
Time Frame: Baseline and after completed each intervention (1 month)
Tumor necrosis factor α (TNF-α) (pg/mL) will be assayed by immunoenzymatic methods.
Baseline and after completed each intervention (1 month)
Changes in inflammatory biomarkers after each intervention with EVOO and the control intervention.
Time Frame: Baseline and after completed each intervention (1 month)
C-reactive protein (CRP) (mg/dL) will be assayed by immunoenzymatic methods.
Baseline and after completed each intervention (1 month)
Changes in nutrients and energy intake after each intervention with EVOO and the control intervention.
Time Frame: Baseline and after completed each intervention (1 month)
A 7-day food recall will be used. The data will be analyzed using a software called Professional Nutritional Calculation Program (PCN Pro)
Baseline and after completed each intervention (1 month)
Changes in physical activity after each intervention with EVOO and the control intervention.
Time Frame: Baseline and after completed each intervention (1 month)
Physical activity will be assessed with the ActiGraph® wGT3X-BT accelerometer
Baseline and after completed each intervention (1 month)
Changes in sleep quality after each intervention with EVOO and the control intervention
Time Frame: Baseline and after completed each intervention (1 month)
Sleep quality will be assessed with the ActiGraph® wGT3X-BT accelerometer.
Baseline and after completed each intervention (1 month)
Assessing variations in inflammatory biomarkers post-intervention for both EVOO treatments and the control group.
Time Frame: Baseline and after completed each intervention (1 month)
Cytokines (pg/mL) will be assayed by immunoenzymatic methods.
Baseline and after completed each intervention (1 month)
Changes in quality of the diet after each intervention with EVOO and the control intervention.
Time Frame: Baseline and after completed each intervention (1 month)
Participants will fill the validated Mediterranean Diet Adherence Screener (MEDAS) questionnaire used in the PREDIMED study. This questionnaire has been validated for the Spanish population and assesses adherence to the Mediterranean diet.The MEDAS score can range from 0 to 17 and higher scores mean better outcome.
Baseline and after completed each intervention (1 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Barcelona

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Clinic of Barcelona
Institut d'Investigacions Biomèdiques August Pi i Sunyer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 19, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 24, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ID-20210929

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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