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

Adult Healthy Volunteers Clinical Trial

— O-LIVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05852275
• Other study ID #: Project nº 171-CES/UCP
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: May 2023
• Source: Universidade Católica Portuguesa
• Contact: Marta Correia, PhD
• Phone: 00351912633095
• Email: mmcorreia[@]ucp.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 30, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Adult Healthy Volunteers

Intervention

Other:
• Olive-oil
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)

Locations

Country	Name	City	State
Portugal	Escola Superior de Biotecnologia, Universidade Católica Portuguesa	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Católica Portuguesa

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Body weight will be assessed using a scale	Day 1
Primary	Body weight	Body weight will be assessed using a scale	Day 50-60
Primary	Body weight	Body weight will be assessed using a scale	Day 100
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Body composition (% of fat mass and % of non-fat mass)	Body composition will be assessed using Body Impedance Analysis (body composition analyser)	Day 1
Primary	Body composition (% of fat mass and % of non-fat mass)	Body composition will be assessed using Body Impedance Analysis (body composition analyser)	Day 100
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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