NCT05852275

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

April 5, 2023

Last Update Submit

May 6, 2023

Conditions

Adult Healthy Volunteers

Keywords

Olive oilinflammationgut microbiotaMediterranean Diet

Outcome Measures

Primary Outcomes (18)

  • 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

Study Arms (1)

Olive oil arm

EXPERIMENTAL

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

Interventions

Olive-oilOTHER

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)

Olive oil arm

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Superior de Biotecnologia, Universidade Católica Portuguesa

Porto, 4169-005, Portugal

RECRUITING

MeSH Terms

Conditions

Inflammation

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ana Gomes, PhD

    Universidade Católica Portuguesa

    STUDY DIRECTOR

Central Study Contacts

Marta Correia, PhD

CONTACT

00351912633095mmcorreia@ucp.pt

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2023

First Posted

May 10, 2023

Study Start

September 1, 2022

Primary Completion

March 1, 2023

Study Completion

May 30, 2023

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations

PT(1)