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

NCT ID: NCT05898113

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-19
• Study Completion Date: 2023-11-24

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.

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.

Conditions

Healthy Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

EXTRA VIRGIN OLIVE OIL

Intervention Type: OTHER

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

OLIVE OIL LOW POLYPHENOL

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

EXTRA VIRGIN OLIVE OIL

Intervention Type: OTHER

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

OLIVE OIL LOW POLYPHENOL

Intervention Type: OTHER

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

Interventions

EXTRA VIRGIN OLIVE OIL

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

Intervention Type: OTHER

OLIVE OIL LOW POLYPHENOL

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: collaborator

Institut d'Investigacions Biomèdiques August Pi i Sunyer

OTHER

Sponsor Role: collaborator

University of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Rosa M Lamuela-Raventós

FULL PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Barcelona, Barcelona, Spain

Countries

Spain

Other Identifiers

ID-20210929

Identifier Type: -

Identifier Source: org_study_id