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The effect of olive leaf extract administration on cardiovascular health

The effect of olive leaf extract administration on cardiovascular health - The effect of olive leaf extract administration on cardiovascular health

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44077
Enrollment
80
Registered
2016-04-21
Start date
2016-07-01
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Risicofactoren voor cardiovasculaire ziekten (borderline) hypercholesterolemia high cholesterol

Interventions

Participants will receive a daily dose of OLECOL or placebo for a period of 8 weeks. Two capsules of OLECOL or placebo have to be ingested every day 30 minutes before the first meal with a glass of

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy individuals, Age: 18-70 years, BMI 25-35 kg/m2, Total cholesterol levels * 5.0 mmol/L.

Exclusion criteria

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, hypertensive medication) * Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study in the 180 days prior to this 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

Design outcomes

Primary

MeasureTime frame
The primary efficady parameter is blood lipid profile, as assesed by blood levels of total cholesterol, HDL and LDL cholesterol and triglycerides.

Secondary

MeasureTime frame
Secondary objectives include the assessment of the effect of OLECOL on lipid peroxidation, platelet aggregation, advanced glycation end-products, blood pressure, liver function, glucose and insulin metabolism, intestinal inflammation, metabolic activity, microbiota composition, and gastrointestinal symptoms.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)