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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of the Aegean
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Changes of Low Density Lipoprotein cholesterol (LDL-cholesterol) from baseline to 30 minutes, 1.5 hours and 3 hours
Study Overview
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 Blood samples were withdrawn in a fasting state, 30, 90 and 180 min after meal consumption.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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Masking Description
Only researchers knew the type of the meal consumed by each participant.
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Control
The meal contained mashed potatoes, homogenized with refined olive oil.
Intervention: Control (Other)
Interventional
The meal contained mashed potatoes, homogenized with the functional olive oil, enhanced with orange peel extract
Intervention: Functional olive oil, enhanced with orange peel extract (Other)
Outcomes
Primary Outcomes
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
Changes of Antioxidant activity from baseline to 30 minutes, 1.5 hours and 3 hours
Time Frame: 3 hours
Plasma Total Antioxidant Capacity concentration
Secondary Outcomes
- Changes of triglycerides from baseline to 30 minutes, 1.5 hours and 3 hours(3 hours)
- Changes of Total cholesterol from baseline to 30 minutes, 1.5 hours and 3 hours(3 hours)
- Changes of glucose from baseline to 30 minutes, 1.5 hours and 3 hours(3 hours)
- Changes of High Density Lipoprotein Cholesterol (HDL-cholesterol) from baseline to 30 minutes, 1.5 hours and 3 hours(3 hours)
- Changes of uric acid from baseline to 30 minutes, 1.5 hours and 3 hours(3 hours)
Investigators
ANTONIOS KOUTELIDAKIS
Professor of Human Nutrition
University of the Aegean