The Effect of Olive Leaf Extract Administration on Cardiovascular Health

• Sponsor: Maastricht University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02990637
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity; Elevated Cholesterol	Dietary Supplement: OLECOL; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Effect of Olive Leaf Extract Administration on Cardiovascular Health
• Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Apr 1, 2017
• Actual Study Completion Date: Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: OLECOL Olive leaf extract	Dietary Supplement: OLECOL; Olive leaf extract
Placebo Comparator: Placebo Maltodextrin	Dietary Supplement: Placebo; Maltodextrin

Outcome Measures

Primary Outcome Measures

1. Blood lipid profile [8 weeks]

Secondary Outcome Measures

1. Lipid peroxidation [8 weeks]

2. Glucose metabolism [8 weeks]

3. Systolic and diastolic blood pressure [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University Medical Center	Maastricht		Netherlands

Sponsors and Collaborators

• Maastricht University Medical Center

Investigators

• Principal Investigator: Ad Masclee, MD, Maastricht University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yala Stevens, MSc., Maastricht University Medical Center
• ClinicalTrials.gov Identifier: NCT02990637
• Other Study ID Numbers: 163004
• First Posted: Dec 13, 2016
• Last Update Posted: May 10, 2017
• Last Verified: May 1, 2017

• Keywords provided by Yala Stevens, MSc., Maastricht University Medical Center: Olive leaf extract; Cardiovascular health; Cholesterol
• Additional relevant MeSH terms: Hypercholesterolemia; Overweight

Study Results

No Results Posted as of May 10, 2017