O-LIVE: Impact of a Portuguese Olive Oil in Health Biomarkers
- Conditions
- Adult Healthy Volunteers
- Interventions
- Other: Olive-oil
- Registration Number
- NCT05852275
- Lead Sponsor
- Universidade Cat贸lica Portuguesa
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Healthy volunteers
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Olive oil arm Olive-oil 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.
- Primary Outcome Measures
Name Time Method Body weight Day 100 Body weight will be assessed using a scale
Bacterial populations in fecal cultures Day 100 Bacterial populations in fecal cultures will be analyzed by microbial DNA extraction and quantitative real-time polymerase-chain reaction (PCR) using specific primers.
Inflammatory gene expression Day 100 Saliva sample will also be collected for subsequent DNA extraction and application of quantitative real-time PCR to determine the expression of inflammatory genes.
Body composition (% of fat mass and % of non-fat mass) Day 100 Body composition will be assessed using Body Impedance Analysis (body composition analyser)
Lipid profile serum level Day 100 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
C-reactive Protein serum level Day 100 A drop of blood will be analysed for biochemical parameters with point of care technology using a finger prick and analysed for PCR levels
glycated hemoglobin A1c serum levels Day 100 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)
Adhesion to mediterranean diet Day 100 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Escola Superior de Biotecnologia, Universidade Cat贸lica Portuguesa
馃嚨馃嚬Porto, Portugal