Department of Nutrition, Food Sciences and Gastronomy. School of Farmacy and Food Sciences. University of Barcelona.
Barcelona, 08028, Spain
NCT Number: NCT05898113
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.
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Notify Me18 year–35 year
All sexes
Interventional
Not applicable
Barcelona, 08028, Spain
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will consume a daily amount of extra virgin olive oil. Can consume the oil either raw or cooked
Participants will consume a daily amount of olive oil low polyphenol. Can consume the oil either raw or cooked
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.
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.
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.
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.
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).
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
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
Time frame: Baseline and after completed each intervention (1 month)
Body weight in kilograms (kg)
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
Time frame: Baseline and after completed each intervention (1 month)
It will be measured with a tape-measure in triplicate, in centimeters (cm)
Time frame: Baseline and after completed each intervention (1 month)
It will be measured with a tape-measure in triplicate, in centimeters (cm)
Time frame: Baseline and after completed each intervention (1 month)
Body fat percentage will be measured using a bioelectrical impedance analysis monitor.
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.
Time frame: Baseline and after completed each intervention (1 month)
Heart rate (bpm) will be measured with an automatic monitor in triplicate.
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.
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.
Time frame: Baseline and after completed each intervention (1 month)
Glucose (mg/dL) will be measured by molecular absorption spectrometry.
Time frame: Baseline and after completed each intervention (1 month)
Cytokines (pg/mL) will be assayed by immunoenzymatic methods.
Time frame: Baseline and after completed each intervention (1 month)
Tumor necrosis factor α (TNF-α) (pg/mL) will be assayed by immunoenzymatic methods.
Time frame: Baseline and after completed each intervention (1 month)
C-reactive protein (CRP) (mg/dL) will be assayed by immunoenzymatic methods.
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)
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.
Time frame: Baseline and after completed each intervention (1 month)
Physical activity will be assessed with the ActiGraph® wGT3X-BT accelerometer
Time frame: Baseline and after completed each intervention (1 month)
Sleep quality will be assessed with the ActiGraph® wGT3X-BT accelerometer.
University of Barcelona
Other
Development of Oil with Healthy Properties Based on Corbella Olive Variety (HEVOOC)
Acronym: HEVOOC
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