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

NCT05898113 | Completed DMC

• 1 other identifier: ID-20210929
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Nutrition

Keywords

Extra virgin olive oil; Microbiota; Polyphenol; MGBA

Outcome Measures

Primary Outcomes (7)

• Changes in brain-derived neurotrophic factor (BDNF) after each intervention with EVOO and the control intervention.

  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 gut microbiota after each intervention with EVOO and the control intervention.

  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.

  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.

  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)

• Changes in the short-chain fatty acids in plasma and feces samples after each intervention with EVOO and the control intervention.

  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.

  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.

  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)

Secondary Outcomes (17)

• Changes in body weight after each intervention with EVOO and the control intervention.

  Baseline and after completed each intervention (1 month)

• Changes in body mass index (BMI) after each intervention with EVOO and the control intervention.

  Baseline and after completed each intervention (1 month)

• Changes in hip circumference after each intervention with EVOO and the control intervention.

  Baseline and after completed each intervention (1 month)

• Changes in waist circumference after each intervention with EVOO and the control intervention.

  Baseline and after completed each intervention (1 month)

• Changes in body composition after each intervention with EVOO and the control intervention.

  Baseline and after completed each intervention (1 month)

Study Arms (2)

EXTRA VIRGIN (intervention / control)

EXPERIMENTAL

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; Other: OLIVE OIL LOW POLYPHENOL

LOW POLYPHENOL (control/intervention)

EXPERIMENTAL

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; Other: OLIVE OIL LOW POLYPHENOL

Interventions

EXTRA VIRGIN OLIVE OIL OTHER

Participants will consume a daily amount of extra virgin olive oil. Can consume the oil either raw or cooked

EXTRA VIRGIN (intervention / control); LOW POLYPHENOL (control/intervention)

OLIVE OIL LOW POLYPHENOL OTHER

Participants will consume a daily amount of olive oil low polyphenol. Can consume the oil either raw or cooked

EXTRA VIRGIN (intervention / control); LOW POLYPHENOL (control/intervention)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Barcelona: lead
• Hospital Clinic of Barcelona: collaborator
• Institut d'Investigacions Biomèdiques August Pi i Sunyer: collaborator

Study Sites (1)

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

Barcelona, Barcelona, 08028, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FULL PROFESSOR

Model Details: 1. EXPERIMENTAL: Extra virgin olive oil (EVOO): should add 0.7 g of Corbella EVOO/ kg body weight to their usual diet per day, either raw or cooked, for one month 2. CONTROL: Olive oil low in polyphenols (OOLP): should add 0.7 g of OOLP/ kg body weight to their usual diet per day, either raw or cooked, for one month

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 12, 2023
• Study Start: June 19, 2023
• Primary Completion: August 10, 2023
• Study Completion: November 24, 2023
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)