The Effect of Olive Leaf Extract Administration on Cardiovascular Health

NCT02990637 | Completed

• 1 other identifier: 163004
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; Elevated Cholesterol

Keywords

Olive leaf extract; Cardiovascular health; Cholesterol

Outcome Measures

Primary Outcomes (1)

• Blood lipid profile

  8 weeks

Secondary Outcomes (3)

• Lipid peroxidation

  8 weeks

• Glucose metabolism

  8 weeks

• Systolic and diastolic blood pressure

  8 weeks

Study Arms (2)

OLECOL

ACTIVE COMPARATOR

Olive leaf extract

Dietary Supplement: OLECOL

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Placebo

Interventions

OLECOL DIETARY_SUPPLEMENT

Olive leaf extract

OLECOL

Placebo DIETARY_SUPPLEMENT

Maltodextrin

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy individuals
• Age between 18 and 70 years
• Total cholesterol levels ≥ 5.0 mmol/L
• BMI 25-35 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 33034707 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases

Study Officials

• Ad Masclee, MD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc.

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 13, 2016
• Study Start: June 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 10, 2017

Record last verified: 2017-05

Locations

NL (1)