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

University of Barcelona

Status: Completed

Conditions: Healthy Nutrition

Treatments: Other: OLIVE OIL LOW POLYPHENOL; Other: EXTRA VIRGIN OLIVE OIL

Study type: Interventional

Funder types: Other

Identifiers

NCT05898113

ID-20210929

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

EXTRA VIRGIN (intervention / control)

Experimental group

Description:

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.

Treatment:

Other: EXTRA VIRGIN OLIVE OIL

Other: OLIVE OIL LOW POLYPHENOL

LOW POLYPHENOL (control/intervention)

Experimental group

Description:

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.

Treatment:

Other: EXTRA VIRGIN OLIVE OIL

Other: OLIVE OIL LOW POLYPHENOL