search
Back to results

The Effect of Olive Leaf Extract Administration on Cardiovascular Health

Primary Purpose

Overweight and Obesity, Elevated Cholesterol

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
OLECOL
Placebo
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring Olive leaf extract, Cardiovascular health, Cholesterol

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

OLECOL

Placebo

Arm Description

Olive leaf extract

Maltodextrin

Outcomes

Primary Outcome Measures

Blood lipid profile

Secondary Outcome Measures

Lipid peroxidation
Glucose metabolism
Systolic and diastolic blood pressure

Full Information

First Posted
December 9, 2016
Last Updated
May 9, 2017
Sponsor
Maastricht University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02990637
Brief Title
The Effect of Olive Leaf Extract Administration on Cardiovascular Health
Official Title
The Effect of Olive Leaf Extract Administration on Cardiovascular Health
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Elevated Cholesterol
Keywords
Olive leaf extract, Cardiovascular health, Cholesterol

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OLECOL
Arm Type
Active Comparator
Arm Description
Olive leaf extract
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
OLECOL
Intervention Description
Olive leaf extract
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Maltodextrin
Primary Outcome Measure Information:
Title
Blood lipid profile
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Lipid peroxidation
Time Frame
8 weeks
Title
Glucose metabolism
Time Frame
8 weeks
Title
Systolic and diastolic blood pressure
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ad Masclee, MD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
33034707
Citation
Stevens Y, Winkens B, Jonkers D, Masclee A. The effect of olive leaf extract on cardiovascular health markers: a randomized placebo-controlled clinical trial. Eur J Nutr. 2021 Jun;60(4):2111-2120. doi: 10.1007/s00394-020-02397-9. Epub 2020 Oct 9.
Results Reference
derived

Learn more about this trial

The Effect of Olive Leaf Extract Administration on Cardiovascular Health

We'll reach out to this number within 24 hrs