The Effect of Olive Leaf Extract Administration on Cardiovascular Health

Overweight and Obesity Clinical Trial

Official title:

The Effect of Olive Leaf Extract Administration on Cardiovascular Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02990637
• Other study ID #: 163004
• Status: Completed
• Phase: N/A
• First received: December 9, 2016
• Last updated: May 9, 2017
• Start date: June 2016
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Elevated Cholesterol
• Hypercholesterolemia
• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• OLECOL
Olive leaf extract
• Placebo
Maltodextrin

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood lipid profile		8 weeks
Secondary	Lipid peroxidation		8 weeks
Secondary	Glucose metabolism		8 weeks
Secondary	Systolic and diastolic blood pressure		8 weeks