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Completed

NCT Number: NCT05771571

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

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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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of the Aegean

Myrina, 81 400, Greece

About this study

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 Blood samples were withdrawn in a fasting state, 30, 90 and 180 min after meal consumption.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional olive oil, enhanced with orange peel extract

Other

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

Control

Other

Refined olive oil

Primary outcomes

  1. Changes of Antioxidant activity from baseline to 30 minutes, 1.5 hours and 3 hours

    Time frame: 3 hours

    Plasma Total Antioxidant Capacity concentration

  2. 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

Secondary outcomes

  1. Changes of Total cholesterol from baseline to 30 minutes, 1.5 hours and 3 hours

    Time frame: 3 hours

    Serum total cholesterol concentration

  2. Changes of High Density Lipoprotein Cholesterol (HDL-cholesterol) from baseline to 30 minutes, 1.5 hours and 3 hours

    Time frame: 3 hours

    Serum HDL-cholesterol (HDL-cholesterol) concentration

  3. Changes of glucose from baseline to 30 minutes, 1.5 hours and 3 hours

    Time frame: 3 hours

    Serum glucose concentration

  4. Changes of triglycerides from baseline to 30 minutes, 1.5 hours and 3 hours

    Time frame: 3 hours

    Serum triglycerides concentration

  5. Changes of uric acid from baseline to 30 minutes, 1.5 hours and 3 hours

    Time frame: 3 hours

    Serum Uric Acid concentration

Sponsors and collaborators

Lead sponsor

University of the Aegean

Other

Registry information

Official study title

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

Acronym: BioliveCT

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 16, 2023
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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