Skip to main content
OpenTrials
Completed

NCT Number: NCT02990637

The Effect of Olive Leaf Extract Administration on Cardiovascular Health

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OLECOL

Dietary Supplement

Olive leaf extract

Placebo

Dietary Supplement

Maltodextrin

Primary outcomes

  1. Blood lipid profile

    Time frame: 8 weeks

Secondary outcomes

  1. Lipid peroxidation

    Time frame: 8 weeks

  2. Glucose metabolism

    Time frame: 8 weeks

  3. Systolic and diastolic blood pressure

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 13, 2016
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.