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

University of the Aegean

Status: Completed

Conditions: Cardiometabolic Risk

Treatments: Other: Control; Other: Functional olive oil, enhanced with orange peel extract

Study type: Interventional

Funder types: Other

Identifiers

NCT05771571

Bio622

Details and patient eligibility

About

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.).

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 Blood samples were withdrawn in a fasting state, 30, 90 and 180 min after meal consumption.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

Enrollment: 21 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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21 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

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

Treatment:

Other: Control

Interventional

Other group

Description:

The meal contained mashed potatoes, homogenized with the functional olive oil, enhanced with orange peel extract

Treatment:

Other: Functional olive oil, enhanced with orange peel extract