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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-12

Study Completion Date

2022-05-19

Brief Summary

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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.).

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Detailed Description

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 Blood samples were withdrawn in a fasting state, 30, 90 and 180 min after meal consumption.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

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Cardiometabolic Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

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

Study Groups

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Control

The meal contained mashed potatoes, homogenized with refined olive oil.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

Refined olive oil

Interventional

The meal contained mashed potatoes, homogenized with the functional olive oil, enhanced with orange peel extract

Group Type OTHER

Functional olive oil, enhanced with orange peel extract

Intervention Type OTHER

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

Interventions

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Functional olive oil, enhanced with orange peel extract

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

Intervention Type OTHER

Control

Refined olive oil

Intervention Type OTHER

Eligibility Criteria

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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)