The Effect of Olive Leaf Extract Administration on Cardiovascular Health

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Elevated Cholesterol; Overweight and Obesity

Treatments: Dietary Supplement: Placebo; Dietary Supplement: OLECOL

Study type: Interventional

Funder types: Other

Identifiers

NCT02990637

163004

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

OLECOL

Active Comparator group

Description:

Olive leaf extract

Treatment:

Dietary Supplement: OLECOL

Placebo

Placebo Comparator group

Description:

Maltodextrin

Treatment:

Dietary Supplement: Placebo