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

NCT05771571 | Completed

• 1 other identifier: Bio622
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.).

Conditions

Cardiometabolic Risk

Keywords

Novel olive oil; Orange peel extract; Postprandial bioactivity; Cardiometabolic risk

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Changes of Total cholesterol 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 glucose from baseline to 30 minutes, 1.5 hours and 3 hours

  3 hours

• Changes of triglycerides 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

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Other: Control

Interventional

OTHER

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

Interventions

Functional olive oil, enhanced with orange peel extract OTHER

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

Interventional

Control OTHER

Refined olive oil

Control

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of the Aegean: lead

Study Sites (1)

University of the Aegean

Myrina, 81 400, Greece

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only researchers knew the type of the meal consumed by each participant.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Human Nutrition

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 16, 2023
• Study Start: May 12, 2022
• Primary Completion: May 19, 2022
• Study Completion: May 19, 2022
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)