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

Study Overview
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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.).

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 Blood samples were withdrawn in a fasting state, 30, 90 and 180 min after meal consumption.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

Official Title
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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

Conditions
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Cardiometabolic Risk

Intervention / Treatment
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* Other: Functional olive oil, enhanced with orange peel extract
* Other: Control


Participation Criteria
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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) Exclusion Criteria: Diabetes or antidiabetic treatment Age <45 and >65 years Malignancies Liver disease

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>The meal contained mashed potatoes, homogenized with refined olive oil. | Other: Control<br>* Refined olive oil<br>|
| Other: Interventional<br>The meal contained mashed potatoes, homogenized with the functional olive oil, enhanced with orange peel extract | Other: Functional olive oil, enhanced with orange peel extract<br>* The functional olive oil was enriched with 10% w/w orange peel extract<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Antioxidant activity from baseline to 30 minutes, 1.5 hours and 3 hours | Plasma Total Antioxidant Capacity concentration | 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 | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Total cholesterol from baseline to 30 minutes, 1.5 hours and 3 hours | Serum total cholesterol concentration | 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 | 3 hours | 
| Changes of glucose from baseline to 30 minutes, 1.5 hours and 3 hours | Serum glucose concentration | 3 hours | 
| Changes of triglycerides from baseline to 30 minutes, 1.5 hours and 3 hours | Serum triglycerides concentration | 3 hours | 
| Changes of uric acid from baseline to 30 minutes, 1.5 hours and 3 hours | Serum Uric Acid concentration | 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Novel olive oil, Orange peel extract, Postprandial bioactivity, Cardiometabolic risk