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

Not Applicable

Completed

• Conditions: Cardiometabolic Risk
• Interventions: Other: Functional olive oil, enhanced with orange peel extract; Other: Control

• Registration Number: NCT05771571
• Lead Sponsor: University of the Aegean

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 Blood samples were withdrawn in a fasting state, 30, 90 and 180 min after meal consumption.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

• Study Start: 2022-05-12
• Primary Completion: 2022-05-19
• Study Completion: 2022-05-19
• Status Verified: 2023-03
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-14
• Study First Posted: 2023-03-16
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Interventional	Functional olive oil, enhanced with orange peel extract	The meal contained mashed potatoes, homogenized with the functional olive oil, enhanced with orange peel extract
Control	Control	The meal contained mashed potatoes, homogenized with refined olive oil.

Primary Outcome Measures

Name	Time	Method
Changes of Low Density Lipoprotein cholesterol (LDL-cholesterol) from baseline to 30 minutes, 1.5 hours and 3 hours	3 hours	Serum LDL-cholesterol concentration
Changes of Antioxidant activity from baseline to 30 minutes, 1.5 hours and 3 hours	3 hours	Plasma Total Antioxidant Capacity concentration

Secondary Outcome Measures

Name	Time	Method
Changes of triglycerides from baseline to 30 minutes, 1.5 hours and 3 hours	3 hours	Serum triglycerides concentration
Changes of Total cholesterol from baseline to 30 minutes, 1.5 hours and 3 hours	3 hours	Serum total cholesterol concentration
Changes of glucose from baseline to 30 minutes, 1.5 hours and 3 hours	3 hours	Serum glucose concentration
Changes of High Density Lipoprotein Cholesterol (HDL-cholesterol) from baseline to 30 minutes, 1.5 hours and 3 hours	3 hours	Serum HDL-cholesterol (HDL-cholesterol) concentration
Changes of uric acid from baseline to 30 minutes, 1.5 hours and 3 hours	3 hours	Serum Uric Acid concentration

Trial Locations

Locations (1)

University of the Aegean; 🇬🇷 Myrina, Greece