NCT07371052

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

14 days

First QC Date

January 15, 2026

Last Update Submit

January 22, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Muscle Soreness

    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

    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

    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

    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

    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

    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 Outcomes (1)

  • 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.

Study Arms (2)

Study group

EXPERIMENTAL

olive leaf extract supplemented

Dietary Supplement: Olive leaf extract

Control group

PLACEBO COMPARATOR

placebo capsule supplemented

Other: Placebo

Interventions

Olive leaf extractDIETARY_SUPPLEMENT

OLE supplement (500 mg, standardized to 25% oleuropein)

Study group
PlaceboOTHER

Sucrose capsules with the same color, scent, and size as OLE capsules.

Control group

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University

Karabük, Central, 78050, Turkey (Türkiye)

Location

MeSH Terms

Interventions

olive leaf extract

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
double blind (participant investigator)
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel assigned
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Research Assistant, Nutritients

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 27, 2026

Study Start

January 1, 2025

Primary Completion

January 15, 2025

Study Completion

February 1, 2025

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations