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Completed

NCT Number: NCT05898113

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

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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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Barcelona, 08028, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extra Virgin Olive Oil

Other

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

OLIVE OIL LOW POLYPHENOL

Other

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

Primary outcomes

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

    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.

  2. Changes in the gut microbiota after each intervention with EVOO and the control intervention.

    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.

  3. Changes in the polyphenols and their metabolites after each intervention with EVOO and the control intervention.

    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.

  4. Changes in carotenoids and their metabolites after each intervention with EVOO and the control intervention.

    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.

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

    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).

  6. Changes in bile acids in plasma and feces samples after each intervention with EVOO and the control intervention.

    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

  7. Changes in cerebrovascular function after each intervention with EVOO and the control intervention.

    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

Secondary outcomes

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

    Time frame: Baseline and after completed each intervention (1 month)

    Body weight in kilograms (kg)

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

    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

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

    Time frame: Baseline and after completed each intervention (1 month)

    It will be measured with a tape-measure in triplicate, in centimeters (cm)

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

    Time frame: Baseline and after completed each intervention (1 month)

    It will be measured with a tape-measure in triplicate, in centimeters (cm)

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

    Time frame: Baseline and after completed each intervention (1 month)

    Body fat percentage will be measured using a bioelectrical impedance analysis monitor.

  6. Changes in blood pressure after each intervention with EVOO and the control intervention.

    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.

  7. Changes in heart rate after each intervention with EVOO and the control intervention.

    Time frame: Baseline and after completed each intervention (1 month)

    Heart rate (bpm) will be measured with an automatic monitor in triplicate.

  8. Changes in lipidic profile after each intervention with EVOO and the control intervention.

    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.

  9. Changes in liver function after each intervention with EVOO and the control intervention.

    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.

  10. Changes in glucose after each intervention with EVOO and the control intervention.

    Time frame: Baseline and after completed each intervention (1 month)

    Glucose (mg/dL) will be measured by molecular absorption spectrometry.

  11. Assessing variations in inflammatory biomarkers post-intervention for both EVOO treatments and the control group.

    Time frame: Baseline and after completed each intervention (1 month)

    Cytokines (pg/mL) will be assayed by immunoenzymatic methods.

  12. Changes in inflammatory biomarkers after each intervention with EVOO and the control intervention.

    Time frame: Baseline and after completed each intervention (1 month)

    Tumor necrosis factor α (TNF-α) (pg/mL) will be assayed by immunoenzymatic methods.

  13. Changes in inflammatory biomarkers after each intervention with EVOO and the control intervention.

    Time frame: Baseline and after completed each intervention (1 month)

    C-reactive protein (CRP) (mg/dL) will be assayed by immunoenzymatic methods.

  14. Changes in nutrients and energy intake after each intervention with EVOO and the control intervention.

    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)

  15. Changes in quality of the diet after each intervention with EVOO and the control intervention.

    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.

  16. Changes in physical activity after each intervention with EVOO and the control intervention.

    Time frame: Baseline and after completed each intervention (1 month)

    Physical activity will be assessed with the ActiGraph® wGT3X-BT accelerometer

  17. Changes in sleep quality after each intervention with EVOO and the control intervention

    Time frame: Baseline and after completed each intervention (1 month)

    Sleep quality will be assessed with the ActiGraph® wGT3X-BT accelerometer.

Sponsors and collaborators

Lead sponsor

University of Barcelona

Other

Collaborators

  • Hospital Clinic of Barcelona
  • Institut d'Investigacions Biomèdiques August Pi i Sunyer

Registry information

Official study title

Development of Oil with Healthy Properties Based on Corbella Olive Variety (HEVOOC)

Acronym: HEVOOC

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 12, 2023
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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