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Investigation of the Acute Effect of Novel Olive Oil on Postprandial Oxidative Stress Biomarkers (BioliveCT)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05771571
Acronym
BioliveCT
Enrollment
21
Registered
2023-03-16
Start date
2022-05-12
Completion date
2022-05-19
Last updated
2023-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiometabolic Risk

Keywords

Novel olive oil, Orange peel extract, Postprandial bioactivity, Cardiometabolic risk

Brief 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 (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 Blood samples were withdrawn in a fasting state, 30, 90 and 180 min after meal consumption.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).

Interventions

OTHERFunctional olive oil, enhanced with orange peel extract

The functional olive oil was enriched with 10% w/w orange peel extract

OTHERControl

Refined olive oil

Sponsors

University of the Aegean
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Masking description

Only researchers knew the type of the meal consumed by each participant.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* Diabetes or antidiabetic treatment * Age \<45 and \>65 years * Malignancies * Liver disease

Design outcomes

Primary

MeasureTime frameDescription
Changes of Antioxidant activity from baseline to 30 minutes, 1.5 hours and 3 hours3 hoursPlasma Total Antioxidant Capacity concentration
Changes of Low Density Lipoprotein cholesterol (LDL-cholesterol) from baseline to 30 minutes, 1.5 hours and 3 hours3 hoursSerum LDL-cholesterol concentration

Secondary

MeasureTime frameDescription
Changes of glucose from baseline to 30 minutes, 1.5 hours and 3 hours3 hoursSerum glucose concentration
Changes of Total cholesterol from baseline to 30 minutes, 1.5 hours and 3 hours3 hoursSerum total cholesterol concentration
Changes of uric acid from baseline to 30 minutes, 1.5 hours and 3 hours3 hoursSerum Uric Acid concentration
Changes of triglycerides from baseline to 30 minutes, 1.5 hours and 3 hours3 hoursSerum triglycerides concentration
Changes of High Density Lipoprotein Cholesterol (HDL-cholesterol) from baseline to 30 minutes, 1.5 hours and 3 hours3 hoursSerum HDL-cholesterol (HDL-cholesterol) concentration

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026