Cardiometabolic Risk Clinical Trial
— BioliveCTOfficial 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
NCT number | NCT05771571 |
Other study ID # | Bio622 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 12, 2022 |
Est. completion date | May 19, 2022 |
Verified date | March 2023 |
Source | University of the Aegean |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.).
Status | Completed |
Enrollment | 21 |
Est. completion date | May 19, 2022 |
Est. primary completion date | May 19, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Greece | University of the Aegean | Myrina |
Lead Sponsor | Collaborator |
---|---|
University of the Aegean |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes of Antioxidant activity from baseline to 30 minutes, 1.5 hours and 3 hours | Plasma Total Antioxidant Capacity concentration | 3 hours | |
Primary | 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 | Changes of Total cholesterol from baseline to 30 minutes, 1.5 hours and 3 hours | Serum total cholesterol concentration | 3 hours | |
Secondary | Changes of High Density Lipoprotein Cholesterol (HDL-cholesterol) from baseline to 30 minutes, 1.5 hours and 3 hours | Serum HDL-cholesterol (HDL-cholesterol) concentration | 3 hours | |
Secondary | Changes of glucose from baseline to 30 minutes, 1.5 hours and 3 hours | Serum glucose concentration | 3 hours | |
Secondary | Changes of triglycerides from baseline to 30 minutes, 1.5 hours and 3 hours | Serum triglycerides concentration | 3 hours | |
Secondary | Changes of uric acid from baseline to 30 minutes, 1.5 hours and 3 hours | Serum Uric Acid concentration | 3 hours |
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