NCT07867977

Brief Summary

To address the physical fatigue and muscle recovery demands in endurance exercise, this study evaluates Grape Seed Extract (GSE) as a potential ergogenic aid. The research aims to investigate whether short-term, high-dose GSE supplementation (1,800 mg/day for 7 days) prolongs cycling time-to-exhaustion (TTE) at 75% VO2max while attenuating exercise-induced muscle damage, metabolic stress, and mood disturbance in collegiate athletes. This study seeks to enhance high-intensity endurance performance and support the development of functional botanical anti-fatigue supplements.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2023

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

7 months

First QC Date

September 14, 2026

Last Update Submit

October 5, 2026

Conditions

Keywords

exercise performancemuscle damagefatigue

Outcome Measures

Primary Outcomes (1)

  • Cycling Time-to-Exhaustion (TTE)

    Participants performed an exhaustive cycling exercise at 75% VO2max, and speed was maintained at 60 rpm on a stationary ergometer bike, where the individual maximum TTE was recorded.

    At baseline (pre-supplementation) and after 7 days of GSE supplementation (post-supplementation)

Secondary Outcomes (10)

  • Serum Creatine Kinase (CK) Concentration

    Assessed at Day 8 (pre-intervention) and Day 43 (post-intervention) at four time points on each experimental day: fasting baseline (07:00), pre-exercise (after 1-hour rest), 30 minutes during cycling exercise, and immediately at exhaustion.

  • Lactate Dehydrogenase (LDH) Activity

    Assessed at Day 8 (pre-intervention) and Day 43 (post-intervention) at four time points on each experimental day : fasting baseline (07:00), pre-exercise (after 1-hour rest), 30 minutes during cycling exercise, and immediately at exhaustion.

  • Uric Acid (UA) Levels

    Assessed at Day 8 (pre-intervention) and Day 43 (post-intervention) at four time points on each experimental day: fasting baseline (07:00), pre-exercise (after 1-hour rest), 30 minutes during cycling exercise, and immediately at exhaustion.

  • Profile of Mood States (POMS) - Vigor Subscale Score

    Assessments were conducted on Day 8 (pre-intervention) and Day 43 (post-intervention), immediately following the time-to-exhaustion (TTE) test.

  • Profile of Mood States (POMS) - Self-esteem Subscale Score

    Assessments were conducted on Day 8 (pre-intervention) and Day 43 (post-intervention), immediately following the time-to-exhaustion (TTE) test.

  • +5 more secondary outcomes

Study Arms (1)

GSE Supplementation Group

EXPERIMENTAL

To approximate that cumulative exposure over a shorter period, Participants were oral 1,800 mg/day of GSE for 7 consecutive days.

Dietary Supplement: Grape seed extract

Interventions

Grape seed extractDIETARY_SUPPLEMENT

Participants were oral 1,800 mg/day of GSE for 7 consecutive days.

GSE Supplementation Group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Capable of completing a maximal oxygen uptake (VO2max) test.

You may not qualify if:

  • diabetes mellitus, respiratory diseases, heart diseases, coagulopathy, hematoma, or other medical illnesses, as well as individuals unable to perform the cycling test to exhaustion or having a fear of blood sampling.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University

Taichung, Taiwan

Location

MeSH Terms

Conditions

Fatigue

Interventions

Grape Seed Extract

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex MixturesPharmaceutical Preparations

Study Officials

  • Jung-Piao Tsao

    China Medical University, China

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: The study employed a single-group, pretest-posttest repeated-measures intervention design. For the preliminary test, maximal oxygen uptake (VO2max) was assessed seven days before the pre-experiment. The pre- and post-intervention experiments were separated by a 28-day interval.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2026

First Posted

October 9, 2026

Study Start

January 9, 2023

Primary Completion

July 27, 2023

Study Completion

July 27, 2023

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations