HealhtyNCT07867977
Grape Seed Extract Supplementation on Cycling Time-to-Exhaustion Performance.
A study testing Grape seed extract in people with Healhty, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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%… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healhty
- What is being tested?
- Grape seed extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Jan 2023to 27 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Capable of completing a maximal oxygen uptake (VO2max) test.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Short-Term Grape Seed Extract Supplementation on Cycling Time-to-Exhaustion Performance, Muscle Damage, and Mood State
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.
Read the detailed description
This study employs a single-group, pretest-posttest repeated-measures intervention design involving healthy, physically active collegiate participants who habitually exercise. During the experimental period, participants are instructed to avoid any form of intensive exercise, intake of caffeinated or alcoholic beverages, or other nutritional supplements. All participants provide voluntary written informed consent. The study protocol was approved by the Human Research Ethics Committee of China Medical University Hospital (CMUH111-REC3-160, Taichung, Taiwan).
For the preliminary test, maximal oxygen uptake (VO2max) is assessed seven days prior to the pre-intervention experiment. The pre- and post-intervention trials are separated by a 28-day interval. On the experimental trial morning, participants report to the laboratory at 07:00 following an overnight fast. Participants rest for one hour following a standardized low-calorie breakfast (300 kcal) and GSE capsule ingestion before the exercise challenge. Following a 5-minute warm-up on an ergometer bike (Monark 894E, Varberg, Sweden), participants perform an exhaustive cycling exercise at 75% VO2max maintaining a pedaling speed of 60 rpm, where individual cycling time-to-exhaustion (TTE) is recorded.
Exhaustion is defined by the attainment of at least two of the following criteria: (1) a rating of perceived exertion (RPE) > 18 on the Borg 6-20 scale; (2) reaching the age-predicted maximal heart rate (220 minus age); and (3) respiratory exchange ratio (RER) > 1.10 measured by an automated cardiopulmonary gas analysis system (Vmax Encore 29c, CareFusion, Palm Springs, CA, USA).
Venous blood samples are collected at four designated time points: fasting baseline (B), pre-exercise (0), 30 minutes during exercise (30), and immediately following the exhaustive cycling exercise challenge (E) to measure concentrations of lactate dehydrogenase (LDH), creatine kinase (CK), and uric acid (UA). In addition, psychological mood states are assessed using the Profile of Mood States (POMS) questionnaire completed immediately following the TTE challenge.
- Conditions
- Healhty
- Being tested
- Grape seed extract
- Keywords
- exercise performance, muscle damage, fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape seed extractDietary supplement
Participants were oral 1,800 mg/day of GSE for 7 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Grape seed extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (pre-supplementation) and after 7 days of GSE supplementation (post-supplementation)
Secondary outcomes (10)
Serum Creatine Kinase (CK) Concentration
A biomarker of muscle damage measured in serum.The absorbance was measured at 450 nm, 505 nm, and 572 nm, respectively, using a microplate reader (Tecan GENios, A-5082, Austria) via enzyme-linked immunosorbent assay (ELISA), and serum concentrations were determined based on the standard curve.Unit of Measure: Units per Liter (U/L).
Measured: 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
A biomarker of muscle damage measured in serum using an automated clinical chemistry analyzer (Beckman Coulter AU5800).Unit of Measure: Units per Liter (U/L).
Measured: 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
Measured in serum as a marker of metabolic stress and muscle damage using commercial analytical reagents. Unit of Measure: Milligrams per deciliter (mg/dL).
Measured: 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
A subscale of the POMS brief version used to evaluate the positive mood state of vigor. It consists of specific adjectives scored on a 5-point scale (1-5). Higher scores indicate higher levels of vigor. Unit of Measure: Units on a scale
Measured: 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
A subscale of the POMS brief version used to evaluate the mood state of self-esteem. Scored on a 5-point scale (1-5). Higher scores indicate higher levels of self-esteem. Unit of Measure: Units on a scale.
Measured: 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) - Tension Subscale Score
A subscale of the POMS brief version used to evaluate the negative mood state of tension. Scored on a 5-point scale (1-5). Higher scores indicate higher levels of tension. Unit of Measure: Units on a scale.
Measured: 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) - Confusion Subscale Score
A subscale of the POMS brief version used to evaluate the negative mood state of confusion. Scored on a 5-point scale (1-5). Higher scores indicate higher levels of confusion. Unit of Measure: Units on a scale.
Measured: 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) - Anger Subscale Score
A subscale of the POMS brief version used to evaluate the negative mood state of anger. Scored on a 5-point scale (1-5). Higher scores indicate higher levels of anger. Unit of Measure: Units on a scale.
Measured: 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) - Fatigue Subscale Score
A subscale of the POMS brief version used to evaluate the negative mood state of fatigue. Scored on a 5-point scale (1-5). Higher scores indicate higher levels of fatigue. Unit of Measure: Units on a scale.
Measured: 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) - Depression Subscale Score
A subscale of the POMS brief version used to evaluate the negative mood state of depression. Scored on a 5-point scale (1-5). Higher scores indicate higher levels of depression. Unit of Measure: Units on a scale.
Measured: Assessments were conducted on Day 8 (pre-intervention) and Day 43 (post-intervention), immediately following the time-to-exhaustion (TTE) test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start9 Jan 2023
- Primary completion27 Jul 2023
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealhtyStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jung-Piao Tsao, Study chair, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867977
- Sponsor's protocol ID
- CMUH111-REC3-160
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Short-Term Grape Seed Extract Supplementation on Cycling Time-to-Exhaustion Performance, Muscle Damage, and Mood State
- ClinicalTrials.gov ID
- NCT07867977
- Acronym / sponsor ID
- CMUH111-REC3-160
- Conditions
- Healhty
- Keywords
- exercise performance, muscle damage, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study employs a single-group, pretest-posttest repeated-measures intervention design involving healthy, physically active collegiate participants who habitually exercise. During the experimental period, participants are instructed to avoid any form of intensive exercise, intake of caffeinated or alcoholic beverages, or other nutritional supplements. All participants provide voluntary written informed consent. The study protocol was approved by the Human Research Ethics Committee of China Medical University Hospital (CMUH111-REC3-160, Taichung, Taiwan).
For the preliminary test, maximal oxygen uptake (VO2max) is assessed seven days prior to the pre-intervention experiment. The pre- and post-intervention trials are separated by a 28-day interval. On the experimental trial morning, participants report to the laboratory at 07:00 following an overnight fast. Participants rest for one hour following a standardized low-calorie breakfast (300 kcal) and GSE capsule ingestion before the exercise challenge. Following a 5-minute warm-up on an ergometer bike (Monark 894E, Varberg, Sweden), participants perform an exhaustive cycling exercise at 75% VO2max maintaining a pedaling speed of 60 rpm, where individual cycling time-to-exhaustion (TTE) is recorded.
Exhaustion is defined by the attainment of at least two of the following criteria: (1) a rating of perceived exertion (RPE) > 18 on the Borg 6-20 scale; (2) reaching the age-predicted maximal heart rate (220 minus age); and (3) respiratory exchange ratio (RER) > 1.10 measured by an automated cardiopulmonary gas analysis system (Vmax Encore 29c, CareFusion, Palm Springs, CA, USA).
Venous blood samples are collected at four designated time points: fasting baseline (B), pre-exercise (0), 30 minutes during exercise (30), and immediately following the exhaustive cycling exercise challenge (E) to measure concentrations of lactate dehydrogenase (LDH), creatine kinase (CK), and uric acid (UA). In addition, psychological mood states are assessed using the Profile of Mood States (POMS) questionnaire completed immediately following the TTE challenge.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| GSE Supplementation Group | Experimental | Dietary Supplement: Grape seed extractTo approximate that cumulative exposure over a shorter period, Participants were oral 1,800 mg/day of GSE for 7 consecutive days. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Capable of completing a maximal oxygen uptake (VO2max) test.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grape seed extractParticipants were oral 1,800 mg/day of GSE for 7 consecutive days. | Dietary supplement | GSE Supplementation Group |
Primary outcome
Cycling Time-to-Exhaustion (TTE)
Time frame: At baseline (pre-supplementation) and after 7 days of GSE supplementation (post-supplementation)
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.
10 secondary outcomes
Serum Creatine Kinase (CK) Concentration
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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) - Tension Subscale Score
Time frame: 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) - Confusion Subscale Score
Time frame: 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) - Anger Subscale Score
Time frame: 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) - Fatigue Subscale Score
Time frame: 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) - Depression Subscale Score
Time frame: Assessments were conducted on Day 8 (pre-intervention) and Day 43 (post-intervention), immediately following the time-to-exhaustion (TTE) test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung-Piao Tsao study chair
China Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grape seed extract in people with Healhty, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cycling Time-to-Exhaustion (TTE) (time frame: At baseline (pre-supplementation) and after 7 days of GSE supplementation (post-supplementation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.