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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02990637
Other study ID # 163004
Secondary ID
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
Health authority
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

Study Design


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
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