Clinical trial NCT05898113: Effect of the Intake of Corbella Extra Virgin Olive Oil on the Microbiota-gut-brain Axis in Healthy Adults (HEVOOC)
Official title: Development of Oil with Healthy Properties Based on Corbella Olive Variety (HEVOOC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Nutrition
Keywords: Extra virgin olive oil
Microbiota
Polyphenol
MGBA
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
name: Institut d'Investigacions Biomèdiques August Pi i Sunyer
First posted: 2023-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes in brain-derived neurotrophic factor (BDNF) after each intervention with EVOO and the control intervention.
timeFrame: Baseline and after completed each intervention (1 month)
measure: Changes in the gut microbiota after each intervention with EVOO and the control intervention.
timeFrame: Baseline and after completed each intervention (1 month)
measure: Changes in the polyphenols and their metabolites after each intervention with EVOO and the control intervention.
timeFrame: Baseline and after completed each intervention (1 month)
measure: Changes in carotenoids and their metabolites after each intervention with EVOO and the control intervention.
timeFrame: Baseline and after completed each intervention (1 month)
measure: Changes in the short-chain fatty acids in plasma and feces samples after each intervention with EVOO and the control intervention.
timeFrame: Baseline and after completed each intervention (1 month)
measure: Changes in bile acids in plasma and feces samples after each intervention with EVOO and the control intervention.
timeFrame: Baseline and after completed each intervention (1 month)
measure: Changes in cerebrovascular function after each intervention with EVOO and the control intervention.
timeFrame: Baseline and after completed each intervention (1 month)
Secondary outcomes:
measure: Changes in body weight after each intervention with EVOO and the control intervention.
timeFrame: Baseline and after completed each intervention (1 month)
measure: Changes in body mass index (BMI) after each intervention with EVOO and the control intervention.
timeFrame: Baseline and after completed each intervention (1 month)
measure: Changes in hip circumference after each intervention with EVOO and the control intervention.
timeFrame: Baseline and after completed each intervention (1 month)
measure: Changes in waist circumference after each intervention with EVOO and the control intervention.
timeFrame: Baseline and after completed each intervention (1 month)
measure: Changes in body composition after each intervention with EVOO and the control intervention.
timeFrame: Baseline and after completed each intervention (1 month)
measure: Changes in blood pressure after each intervention with EVOO and the control intervention.
timeFrame: Baseline and after completed each intervention (1 month)
measure: Changes in heart rate after each intervention with EVOO and the control intervention.
timeFrame: Baseline and after completed each intervention (1 month)
measure: Changes in lipidic profile after each intervention with EVOO and the control intervention.
timeFrame: Baseline and after completed each intervention (1 month)
measure: Changes in liver function after each intervention with EVOO and the control intervention.
timeFrame: Baseline and after completed each intervention (1 month)
measure: Changes in glucose after each intervention with EVOO and the control intervention.
timeFrame: Baseline and after completed each intervention (1 month)
measure: Assessing variations in inflammatory biomarkers post-intervention for both EVOO treatments and the control group.
timeFrame: Baseline and after completed each intervention (1 month)
measure: Changes in inflammatory biomarkers after each intervention with EVOO and the control intervention.
timeFrame: Baseline and after completed each intervention (1 month)
measure: Changes in inflammatory biomarkers after each intervention with EVOO and the control intervention.
timeFrame: Baseline and after completed each intervention (1 month)
measure: Changes in nutrients and energy intake after each intervention with EVOO and the control intervention.
timeFrame: Baseline and after completed each intervention (1 month)
measure: Changes in quality of the diet after each intervention with EVOO and the control intervention.
timeFrame: Baseline and after completed each intervention (1 month)
measure: Changes in physical activity after each intervention with EVOO and the control intervention.
timeFrame: Baseline and after completed each intervention (1 month)
measure: Changes in sleep quality after each intervention with EVOO and the control intervention
timeFrame: Baseline and after completed each intervention (1 month)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Department of Nutrition, Food Sciences and Gastronomy. School of Farmacy and Food Sciences. University of Barcelona.
Study officials:
References: