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The Effect of Olive Leaf Extract Administration on Cardiovascular Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02990637
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : May 10, 2017
Information provided by (Responsible Party):
Yala Stevens, 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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Elevated Cholesterol Dietary Supplement: OLECOL Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : June 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: OLECOL
Olive leaf extract
Dietary Supplement: OLECOL
Olive leaf extract

Placebo Comparator: Placebo
Dietary Supplement: Placebo

Primary Outcome Measures :
  1. Blood lipid profile [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Lipid peroxidation [ Time Frame: 8 weeks ]
  2. Glucose metabolism [ Time Frame: 8 weeks ]
  3. Systolic and diastolic blood pressure [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02990637

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Maastricht University Medical Center
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
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Principal Investigator: Ad Masclee, MD Maastricht University Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Yala Stevens, MSc., Maastricht University Medical Center Identifier: NCT02990637    
Other Study ID Numbers: 163004
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017
Keywords provided by Yala Stevens, Maastricht University Medical Center:
Olive leaf extract
Cardiovascular health
Additional relevant MeSH terms:
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Body Weight
Lipid Metabolism Disorders
Metabolic Diseases