Cardiometabolic RiskBioliveCTNCT05771571
Investigation of the Acute Effect of Novel Olive Oil on Postprandial Oxidative Stress Biomarkers (BioliveCT)
A study testing Functional olive oil, enhanced with orange peel extract in people with Cardiometabolic Risk, run by University of the Aegean at 1 site in Greece.
Trial summary
The purpose of this study was the investigation of the hypothesis that the enhancement of a refined olive oil with orange peel extract, may improve the postprandial lipidemic, glycemic profile and blood oxidative status, of volunteers with high cardiometabolic risk, due to increased content of bioactive compounds… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Cardiometabolic Risk
- What is being tested?
- Functional olive oil, enhanced with orange peel extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteGreece
- Study dates
- 12 May 2022to 19 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 30 to 65 years
- Completion of at least 3 of the following parameters:
- Hypertension (Systolic pressure ≥ 140mm Hydrargyrum or diastolic pressure ≥ 90mm Hydrargyrum or taking antihypertensive treatment)
- High levels of LDL-cholesterol (≥130mg/dL)
- High serum triglycerides (≥150mg/dL)
- Waist circumference >102cm for men and >98cm for women
- Family history (Myocardial infarction or sudden death in a 1st degree relative <55 years old)
- High fasting glucose (100-125 mg/dL)
Who cannot join
- Diabetes or antidiabetic treatment
- Age <45 and >65 years
- Malignancies
- Liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effect of a Novel, Functional Olive Oil, Enhanced With Orange Peel Extract, on Postprandial Biomarkers of Inflammation and Oxidative Stress of Volunteers at High Cardiometabolic Risk
The purpose of this study was the investigation of the hypothesis that the enhancement of a refined olive oil with orange peel extract, may improve the postprandial lipidemic, glycemic profile and blood oxidative status, of volunteers with high cardiometabolic risk, due to increased content of bioactive compounds (polyphenols, carotenoids etc.).
Read the detailed description
In a randomized, acute, single-blinded and cross-over study, participated 21 volunteers with high cardiometabolic risk, aged 30-65, were randomized and divided into two groups. The first group consumed a meal of mashed potatoes with added refined olive oil, rich in fat and carbohydrates (300g, control meal), while the second group consumed mashed potatoes with added olive oil, enhanced with 10% w/w orange peel extract (functional meal). After a one-week washout period, the volunteers were crossed over and consumed the meals in reverse. Blood samples were withdrawn in a fasting state, 30, 90 and 180 min after meal consumption. Plasma Total Antioxidant Capacity (FRAP), serum lipid levels [Total, High-Density Lipoprotein (HDL-) and Low-Density Lipoprotein (LDL-) cholesterol and triglycerides], glucose and uric acid were determined at each time point using a biochemical analyzer (Roche Cobas c111).
- Conditions
- Cardiometabolic Risk
- Being tested
- Functional olive oil, enhanced with orange peel extract, Control
- Keywords
- Novel olive oil, Orange peel extract, Postprandial bioactivity, Cardiometabolic risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional olive oil, enhanced with orange peel extractOther
The functional olive oil was enriched with 10% w/w orange peel extract
ControlOther
Refined olive oil
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | The meal contained mashed potatoes, homogenized with refined olive oil. Receives: Other: Control |
| Interventional | Other | The meal contained mashed potatoes, homogenized with the functional olive oil, enhanced with orange peel extract Receives: Other: Functional olive oil, enhanced with orange peel extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Antioxidant activity from baseline to 30 minutes, 1.5 hours and 3 hours
Plasma Total Antioxidant Capacity concentration
Measured: 3 hours
Changes of Low Density Lipoprotein cholesterol (LDL-cholesterol) from baseline to 30 minutes, 1.5 hours and 3 hours
Serum LDL-cholesterol concentration
Measured: 3 hours
Secondary outcomes (5)
Changes of Total cholesterol from baseline to 30 minutes, 1.5 hours and 3 hours
Serum total cholesterol concentration
Measured: 3 hours
Changes of High Density Lipoprotein Cholesterol (HDL-cholesterol) from baseline to 30 minutes, 1.5 hours and 3 hours
Serum HDL-cholesterol (HDL-cholesterol) concentration
Measured: 3 hours
Changes of glucose from baseline to 30 minutes, 1.5 hours and 3 hours
Serum glucose concentration
Measured: 3 hours
Changes of triglycerides from baseline to 30 minutes, 1.5 hours and 3 hours
Serum triglycerides concentration
Measured: 3 hours
Changes of uric acid from baseline to 30 minutes, 1.5 hours and 3 hours
Serum Uric Acid concentration
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start12 May 2022
- Primary completion19 May 2022
- Study completion19 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants were randomly divided into control and interventional group. In the first study period, the control group consumed the meal with the refined olive oil and the interventional group received the meal with the novel, functional olive oil, enhanced with 10% w/w orange peel extract. After a washout week participants were crossed over and consumed the meals in reverse.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Aegean
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANTONIOS KOUTELIDAKIS, University of the Aegean
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771571
- Sponsor's protocol ID
- Bio622
- Acronym
- BioliveCT
- Status last verified
- Mar 2023
- First submitted
- 3 Mar 2023
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No one individual participant data is planned to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of a Novel, Functional Olive Oil, Enhanced With Orange Peel Extract, on Postprandial Biomarkers of Inflammation and Oxidative Stress of Volunteers at High Cardiometabolic Risk
- ClinicalTrials.gov ID
- NCT05771571
- Acronym / sponsor ID
- BioliveCT / Bio622
- Conditions
- Cardiometabolic Risk
- Keywords
- Novel olive oil, Orange peel extract, Postprandial bioactivity, Cardiometabolic risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of the AegeanUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- 19 May 2022 (actual)
- Study completion
- 19 May 2022 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was the investigation of the hypothesis that the enhancement of a refined olive oil with orange peel extract, may improve the postprandial lipidemic, glycemic profile and blood oxidative status, of volunteers with high cardiometabolic risk, due to increased content of bioactive compounds (polyphenols, carotenoids etc.).
Detailed description
In a randomized, acute, single-blinded and cross-over study, participated 21 volunteers with high cardiometabolic risk, aged 30-65, were randomized and divided into two groups. The first group consumed a meal of mashed potatoes with added refined olive oil, rich in fat and carbohydrates (300g, control meal), while the second group consumed mashed potatoes with added olive oil, enhanced with 10% w/w orange peel extract (functional meal). After a one-week washout period, the volunteers were crossed over and consumed the meals in reverse. Blood samples were withdrawn in a fasting state, 30, 90 and 180 min after meal consumption. Plasma Total Antioxidant Capacity (FRAP), serum lipid levels [Total, High-Density Lipoprotein (HDL-) and Low-Density Lipoprotein (LDL-) cholesterol and triglycerides], glucose and uric acid were determined at each time point using a biochemical analyzer (Roche Cobas c111).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomly divided into control and interventional group. In the first study period, the control group consumed the meal with the refined olive oil and the interventional group received the meal with the novel, functional olive oil, enhanced with 10% w/w orange peel extract. After a washout week participants were crossed over and consumed the meals in reverse.
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: ControlThe meal contained mashed potatoes, homogenized with refined olive oil. |
| Interventional | Other | Other: Functional olive oil, enhanced with orange peel extractThe meal contained mashed potatoes, homogenized with the functional olive oil, enhanced with orange peel extract |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age from 30 to 65 years
- Completion of at least 3 of the following parameters:
Key exclusion criteria (4 listed)
- Diabetes or antidiabetic treatment
- Age <45 and >65 years
- Malignancies
- Liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional olive oil, enhanced with orange peel extractThe functional olive oil was enriched with 10% w/w orange peel extract | Other | Interventional |
| ControlRefined olive oil | Other | Control |
Primary outcome
Changes of Antioxidant activity from baseline to 30 minutes, 1.5 hours and 3 hours
Time frame: 3 hours
Plasma Total Antioxidant Capacity concentration
Changes of Low Density Lipoprotein cholesterol (LDL-cholesterol) from baseline to 30 minutes, 1.5 hours and 3 hours
Time frame: 3 hours
Serum LDL-cholesterol concentration
5 secondary outcomes
Changes of Total cholesterol from baseline to 30 minutes, 1.5 hours and 3 hours
Time frame: 3 hours
Changes of High Density Lipoprotein Cholesterol (HDL-cholesterol) from baseline to 30 minutes, 1.5 hours and 3 hours
Time frame: 3 hours
Changes of glucose from baseline to 30 minutes, 1.5 hours and 3 hours
Time frame: 3 hours
Changes of triglycerides from baseline to 30 minutes, 1.5 hours and 3 hours
Time frame: 3 hours
Changes of uric acid from baseline to 30 minutes, 1.5 hours and 3 hours
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: No. No one individual participant data is planned to be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional olive oil, enhanced with orange peel extract in people with Cardiometabolic Risk, run by University of the Aegean at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Antioxidant activity from baseline to 30 minutes, 1.5 hours and 3 hours (time frame: 3 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.