The Effect of Olive Leaf Extract Administration on Cardiovascular Health

Not Applicable

Completed

• Conditions: Elevated Cholesterol; Overweight and Obesity
• Interventions: Dietary Supplement: OLECOL; Dietary Supplement: Placebo

• Registration Number: NCT02990637
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

The purpose of this study is to investigate the effects of daily supplementation of OLECOL for a period of 8 weeks on cardiovascular risk markers.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-12-09
• Study First Submitted QC: 2016-12-09
• Study First Posted: 2016-12-13
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-09
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Healthy individuals
• Age between 18 and 70 years
• Total cholesterol levels ≥ 5.0 mmol/L
• BMI 25-35 kg/m2

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, hypertension medication)
• Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study in the 180 days prior to the 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: PARALLEL

Arm && Interventions

Group	Intervention	Description
OLECOL	OLECOL	Olive leaf extract
Placebo	Placebo	Maltodextrin

Primary Outcome Measures

Name	Time	Method
Blood lipid profile	8 weeks

Secondary Outcome Measures

Name	Time	Method
Glucose metabolism	8 weeks
Systolic and diastolic blood pressure	8 weeks
Lipid peroxidation	8 weeks

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands