O-LIVE: Impact of a Portuguese Olive Oil in Health Biomarkers

Study Overview
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Brief Summary
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This research project, approved and funded, is part of a larger project, entitled Healthy Soil for Food, which completes several work packages, one of which is a clinical research submitted to Ethics Committee entitled O-LIVE: Impact of olive oil Portuguese in biomarkers of healthy volunteers. The main objective of this work is to evaluate the impact of ingestion of an olive oil rich in polyphenols on clinical biomarkers and parameters, such as anthropometric measurements, on inflammatory gene expression regulation and on the composition of the intestinal microbiota.

Detailed Description
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Olive oil is an ancient product that is crucial for social cohesion and for local economies in the Mediterranean region, particularly in Portugal. There is ample evidence on the protective effect of olive oil in cardiovascular disease, diabetes, oncological diseases and neurological degeneration. Furthermore, olive oil has been shown to increase the rate of oxidation, inhibiting lipogenesis and stimulating lipolysis, in addition to affecting the expression of receptors involved in weight regulation and fat use. These health benefits of olive oil derive from its specific nutritional composition, with monounsaturated fatty acids, polyphenols and phenolic compounds, which act on metabolism, modulation of inflammatory responses and gene expression. But the composition of olive oil can vary considerably depending on the type of cultivation of olive trees, soil management practices, as well as the extraction and technological processes involved in olive oil production. In this work the investigators will use an olive oil rich in polyphenols (produced in a sustainable and local manner) and evaluate its effect on several important clinical parameters involved in chronic diseases. The investigators anticipate that the results of this work will help support the relationship between consuming higher polyphenol olive oil and improved overall health.

Official Title
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O-LIVE: Impact of a Portuguese Olive Oil in Health Biomarkers

Conditions
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Adult Healthy Volunteers

Intervention / Treatment
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* Other: Olive-oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers Exclusion Criteria: Current active infections Medications (Antidepressant medication, Antibiotics, anti-inflammatory, Angiotensin Converting Enzyme inhibitors, insulin and oral anti-diabetic medication) Dietary supplements (minerals and oligoelements, antioxidants, n-3 polyunsaturated fatty acids, n-6 polyunsaturated fatty acids, n-9 fatty acids) Presence of ant chronic/metabolic diseases: Diabetes Cancer Inflammatory diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: This project consists of a quasi-experimental clinical study whose target population is healthy, voluntary adults. Participants will be recruited among men and women, aged 18 years or over, healthy, who belong to the community of the University (Portuguese Catholic University - Porto campus) and who do not meet any of the exclusion criteria. Individuals will be invited to participate voluntarily in this study, receiving detailed information about the investigation, in order to allow an informed, informed and free decision. Individuals who agree to participate sign an informed consent.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olive oil arm<br>Participants will include, in their usual diet, the daily intake of 30 mL of an olive oil rich in polyphenols (intervention group) for 100 days. At the beginning (day 1), in the middle (between days 50 and 60) and at the end of the intervention period (day 100), participants will be evaluated. | Other: Olive-oil<br>* Participants will add to their usual diet a daily intake of 30 mL of an olive oil rich in polyphenols for 3-months (100 days)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Body weight will be assessed using a scale | Day 1 | 
| Body weight | Body weight will be assessed using a scale | Day 50-60 | 
| Body weight | Body weight will be assessed using a scale | Day 100 | 
| Bacterial populations in fecal cultures | Bacterial populations in fecal cultures will be analysed by microbial DNA extraction and quantitative real-time polymerase-chain reaction (PCR) using specific primers. | Day 1 | 
| Bacterial populations in fecal cultures | Bacterial populations in fecal cultures will be analyzed by microbial DNA extraction and quantitative real-time polymerase-chain reaction (PCR) using specific primers. | Day 100 | 
| Inflammatory gene expression | Saliva sample will also be collected for subsequent DNA extraction and application of quantitative real-time PCR to determine the expression of inflammatory genes. | Day 1 | 
| Inflammatory gene expression | Saliva sample will also be collected for subsequent DNA extraction and application of quantitative real-time PCR to determine the expression of inflammatory genes. | Day 100 | 
| Body composition (% of fat mass and % of non-fat mass) | Body composition will be assessed using Body Impedance Analysis (body composition analyser) | Day 1 | 
| Body composition (% of fat mass and % of non-fat mass) | Body composition will be assessed using Body Impedance Analysis (body composition analyser) | Day 100 | 
| Adhesion to mediterranean diet | PREDIMED (PREvencion con Diet MEDiterranea) is a brief 14-item tool able to capture a strong monotonic inverse association between adherence to a good quality dietary pattern (Mediterranean diet) and obesity indexes in a population of adults (doi:10.1371/journal.pone.0043134) | Day 1 | 
| Adhesion to mediterranean diet | PREDIMED (PREvencion con Diet MEDiterranea) is a brief 14-item tool able to capture a strong monotonic inverse association between adherence to a good quality dietary pattern (Mediterranean diet) and obesity indexes in a population of adults (doi:10.1371/journal.pone.0043134) | Day 50-60 | 
| Adhesion to mediterranean diet | PREDIMED (PREvencion con DIeta MEDiterranea) is a brief 14-item tool able to capture a strong monotonic inverse association between adherence to a good quality dietary pattern (Mediterranean diet) and obesity indexes in a population of adults (doi:10.1371/journal.pone.0043134) | Day 100 | 
| Lipid profile serum level | A drop of blood will be analysed for biochemical parameters with point of care technology using a finger prick and analysed for total cholesterol, HDL, LDL and triacylglycerols | Day 1 | 
| Lipid profile serum level | A drop of blood will be analysed for biochemical parameters with point of care technology using a finger prick and analysed for total cholesterol, HDL, LDL and triacylglycerols | Day 100 | 
| C-reactive Protein serum level | A drop of blood will be analysed for biochemical parameters with point of care technology using a finger prick and analysed for PCR levels | Day 1 | 
| C-reactive Protein serum level | A drop of blood will be analysed for biochemical parameters with point of care technology using a finger prick and analysed for PCR levels | Day 100 | 
| glycated hemoglobin A1c serum levels | drop of blood will be analysed for biochemical parameters with point of care technology using a finger prick and analysed for levels glycated hemoglobin (ha1c) | Day 1 | 
| glycated hemoglobin A1c serum levels | drop of blood will be analysed for biochemical parameters with point of care technology using a finger prick and analysed for levels glycated hemoglobin (ha1c) | Day 100 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Olive oil, inflammation, gut microbiota, Mediterranean Diet