The effect of olive leaf extract administration on cardiovascular health

Completed

• Conditions: Risicofactoren voor cardiovasculaire ziekten; (borderline) hypercholesterolemia; high cholesterol; overweight; obesity

• Registration Number: NL-OMON44077
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Healthy individuals, Age: 18-70 years, BMI 25-35 kg/m2, Total cholesterol levels * 5.0 mmol/L.

Exclusion Criteria

* History of severe cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat). Dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and /or laboratory assessments that might limit participation in or completion of the study protocol.
* Diabetes
* Use of medication that might have influence on endpoints (e.g. cholesterol lowering medication, hypertensive medication)
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study in the 180 days prior to this study
* Use of antibiotics in the 30 days prior to the start of the study
* Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine
* Pregnancy, lactation
* Abuse of products (> 20 alcoholic consumptions per week and drugs)
* Smoking
* Weight gain or loss (> 3 kg in previous 3 months)
* High physical activity (>4.5 hours of running/week)
* History of any side effects towards intake of olives

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficady parameter is blood lipid profile, as assesed by blood<br /><br>levels of total cholesterol, HDL and LDL cholesterol and triglycerides.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives include the assessment of the effect of OLECOL on lipid<br /><br>peroxidation, platelet aggregation, advanced glycation end-products, blood<br /><br>pressure, liver function, glucose and insulin metabolism, intestinal<br /><br>inflammation, metabolic activity, microbiota composition, and gastrointestinal<br /><br>symptoms. </p><br>