The Effect of Olive Leaf Extract Administration on Cardiovascular Health

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Olive Leaf Extract Administration on Cardiovascular Health

Conditions
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Overweight and Obesity, Elevated Cholesterol

Intervention / Treatment
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* Dietary Supplement: OLECOL
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OLECOL<br>Olive leaf extract | Dietary Supplement: OLECOL<br>* Olive leaf extract<br>|
| Placebo Comparator: Placebo<br>Maltodextrin | Dietary Supplement: Placebo<br>* Maltodextrin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lipid profile |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid peroxidation |  | 8 weeks | 
| Glucose metabolism |  | 8 weeks | 
| Systolic and diastolic blood pressure |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholesterol, Olive leaf extract, Cardiovascular health