Clinical trial NCT05852275: O-LIVE: Impact of a Portuguese Olive Oil in Health Biomarkers
Official title: O-LIVE: Impact of a Portuguese Olive Oil in Health Biomarkers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adult Healthy Volunteers
Keywords: Olive oil
inflammation
gut microbiota
Mediterranean Diet
Lead sponsor: Universidade Católica Portuguesa
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Body weight
timeFrame: Day 1
measure: Body weight
timeFrame: Day 50-60
measure: Body weight
timeFrame: Day 100
measure: Bacterial populations in fecal cultures
timeFrame: Day 1
measure: Bacterial populations in fecal cultures
timeFrame: Day 100
measure: Inflammatory gene expression
timeFrame: Day 1
measure: Inflammatory gene expression
timeFrame: Day 100
measure: Body composition (% of fat mass and % of non-fat mass)
timeFrame: Day 1
measure: Body composition (% of fat mass and % of non-fat mass)
timeFrame: Day 100
measure: Adhesion to mediterranean diet
timeFrame: Day 1
measure: Adhesion to mediterranean diet
timeFrame: Day 50-60
measure: Adhesion to mediterranean diet
timeFrame: Day 100
measure: Lipid profile serum level
timeFrame: Day 1
measure: Lipid profile serum level
timeFrame: Day 100
measure: C-reactive Protein serum level
timeFrame: Day 1
measure: C-reactive Protein serum level
timeFrame: Day 100
measure: glycated hemoglobin A1c serum levels
timeFrame: Day 1
measure: glycated hemoglobin A1c serum levels
timeFrame: Day 100
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Escola Superior de Biotecnologia, Universidade Católica Portuguesa
Study officials:
affiliation: Universidade Católica Portuguesa
name: Ana Gomes, PhD
role: STUDY_DIRECTOR
References: