- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07371052
Olive Leaf Extract in Handball Players
Effects of Short-Term Olive Leaf Extract Supplementation in Elite Male Handball Players
Olive leaf extract (OLE) is a natural supplement rich in phenolic compounds, especially oleuropein, which has antioxidant properties that may support recovery after physical exercise. While OLE has been studied for various health-related effects, its potential impact on exercise recovery and performance in elite athletes remains unclear.
This randomized, double-blind, placebo-controlled study was designed to evaluate the effects of four weeks of OLE supplementation on physical performance, sleep quality, and post-exercise muscle soreness in elite male handball players aged 18 to 25 years. Participants were randomly assigned to receive either a daily OLE supplement (500 mg, standardized to 25% oleuropein) or a placebo for four weeks. Physical performance, sleep quality, and muscle soreness were assessed at baseline, during the intervention, and at the end of the study period. Muscle soreness was additionally evaluated at 12 and 24 hours following exercise sessions.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Central
-
Karabük, Central, Turkey (Türkiye), 78050
- Karabuk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male elite handball players aged 18 years or older
- Free from any diagnosed chronic disease, as determined by medical history
- Not following a calorie-restricted diet within the previous six months
- No use of nutritional supplements within the previous six months
Exclusion Criteria:
- Age under 18 years
- Smoking or alcohol consumption
- Presence of any diagnosed chronic disease
- Adherence to a regular calorie-restricted diet within the previous six months
- Use of nutritional supplements during the previous six months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study group
olive leaf extract supplemented
|
OLE supplement (500 mg, standardized to 25% oleuropein)
|
|
Placebo Comparator: Control group
placebo capsule supplemented
|
Sucrose capsules with the same color, scent, and size as OLE capsules.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Soreness
Time Frame: Baseline, After intervention (two week later), After intervention (fourt week later)
|
The severity of muscle soreness will be assessed using the Visual Analog Scale (VAS).
Patients choose the appropriate score between 0 and 10.
Higher scores indicate higher muscle soreness levels.
|
Baseline, After intervention (two week later), After intervention (fourt week later)
|
|
Squat jump height
Time Frame: Performance outcomes were assessed at baseline, week 2, and week 4 of the intervention period.
|
Lower-body explosive performance was assessed using the squat jump test.
Jump height was measured in centimeters (cm) with higher values indicating better explosive performance.
|
Performance outcomes were assessed at baseline, week 2, and week 4 of the intervention period.
|
|
Peak anaerobic power
Time Frame: baseline, week 2, and week 4.
|
Peak anaerobic power was assessed using the Wingate anaerobic test.
Peak power output was recorded in watts (W) during the 30-second maximal cycling test.
Higher values indicate greater anaerobic power.
|
baseline, week 2, and week 4.
|
|
Countermovement jump height
Time Frame: Assessments were conducted at baseline, week 2, and week 4. Higher values indicate better explosive performance.
|
Lower-body explosive performance was assessed using the countermovement jump test.
Jump height was measured in centimeters (cm) with higher values indicating better explosive performance.
|
Assessments were conducted at baseline, week 2, and week 4. Higher values indicate better explosive performance.
|
|
Mean anaerobic power
Time Frame: Baseline, week 2, and week 4
|
Mean anaerobic power was assessed using the Wingate anaerobic test.
Mean power output was calculated as the average power produced over the 30-second test and recorded in watts (W).
Higher values indicate better anaerobic capacity.
|
Baseline, week 2, and week 4
|
|
Fatigue index
Time Frame: Baseline, week 2, and week 4
|
Fatigue index was assessed using the Wingate anaerobic test and calculated as the percentage decline in power output from peak to minimum power during the 30-second test.
Higher values indicate greater fatigue.
|
Baseline, week 2, and week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep quality
Time Frame: Total PSQI scores were recorded at baseline, week 2, and week 4 to evaluate changes in perceived sleep quality during the supplementation period.
|
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI) total score.
The PSQI is a validated self-reported questionnaire consisting of 19 items, yielding a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality.
|
Total PSQI scores were recorded at baseline, week 2, and week 4 to evaluate changes in perceived sleep quality during the supplementation period.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- handball players
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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