HealthyNCT07440394
Evaluation of Pine Bark Extract for Anti-fatigue Ergogenic Properties
A study testing PBE (PBE trial) in people with Healthy, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
This research proposal aims to elucidate the physiological responses to pine bark extract supplementation during a single bout of high-intensity cycling exercise at 70% VO₂max and the subsequent recovery phase. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PBE (PBE trial)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Apr 2023to 31 Dec 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
- A minimum of three years of regular exercise habits.
Who cannot join
- Have smoking and drinking habits.
- People who feel unwell due to other reasons during the experiment.
- Individuals with respiratory disorders.
- Severe lower limb musculoskeletal injuries within the past six months.
Trial locations and contacts
1 site in 1 country.
About this study
This research proposal aims to elucidate the physiological responses to pine bark extract supplementation during a single bout of high-intensity cycling exercise at 70% VO₂max and the subsequent recovery phase. Specifically, the study seeks to investigate the underlying mechanisms by which pine bark extract modulates exercise-induced fatigue and metabolic fitness, and to determine whether such supplementation may enhance endurance performance in the post-recovery period.
Read the detailed description
The primary active component of natural pine bark extract (PBE) is proanthocyanidins, which possess antioxidant, anti-inflammatory, and endothelial function-enhancing properties. These attributes suggest its potential as an ergogenic aid to improve exercise performance. In this study, 14 healthy participants will be randomly assigned to receive either 300 mg/day of PBE or a placebo for 4 consecutive days. Following supplementation, participants will consume a low-calorie meal (300 kcal) accompanied by either the placebo or PBE and rest for one hour. One hour after capsule ingestion, participants will perform a 60-minute cycling exercise at 70% VO₂max. Upon completion of the exercise challenge, they will consume a post-exercise meal adjusted to body weight. After a 3-hour recovery period, subjects will undergo an anaerobic power test followed by an endurance test at 75% VO₂max to volitional exhaustion. Gas exchange and blood samples will be collected at multiple time points: pre- and post-initial cycling session, during the recovery phase, and following the exhaustive endurance test. Gas samples will be analyzed to determine rates of fat and carbohydrate oxidation. Blood biomarkers will be assessed for glucose, superoxidase dismutase (SOD), malondialdehyde (MDA), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), creatine kinase (CK), lactate dehydrogenase (LDH), and uric acid (UA).
- Conditions
- Healthy
- Being tested
- Placebo (Placebo trial), PBE (PBE trial)
- Keywords
- pine bark extract, exercise performance, Maximal oxygen consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (Placebo trial)Other
The Placebo capsule supplement was taken for 4 days (3 capsules per day)
PBE (PBE trial)Other
The PBE capsule supplement was taken for 4 days, with a daily dosage of 300 mg of PBE (equivalent to 3 capsules per day, each containing 100 mg of PBE).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Containing edible yellow No. 4, edible yellow No. 5, sucrose, silica, talc, oxidized starch, gelatin, magnesium stearate, and palm wax. Receives: Other: Placebo (Placebo trial); Other: PBE (PBE trial) |
| PBE | Experimental | Each capsule containing 100 mg of Pycnogenol®, Taiwan Receives: Other: Placebo (Placebo trial); Other: PBE (PBE trial) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Exhaustion (TTE)
The total duration (in minutes) from the start of the graded exercise test until the participant reaches volitional exhaustion or can no longer maintain the required cadence of 60 RPM.
Unit of Measure: Minutes
Measured: Baseline and at the end of the 4-week crossover period.
Secondary outcomes (19)
Serum Tumor Necrosis Factor-alpha (TNF-alpha) Concentration
A pro-inflammatory cytokine measured in serum using a commercial ELISA kit (BioLegend) to evaluate the inflammatory response.Unit of Measure: Picograms per milliliter (pg/mL)
Measured: 7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.
Superoxide Dismutase (SOD) Activity
biomarker used to evaluate total antioxidant capacity. Serum SOD activity is measured using a commercial colorimetric assay kit and read with an ELISA plate reader.Unit of Measure: Units per milliliter (U/mL).
Measured: 7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.
Blood Glucose Levels
Estimated from blood using the glucometer to assess glycemic response during the trials.
Measured: 7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.
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: 7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.
Lactate Dehydrogenase (LDH) Activity
Description: 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: 7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.
Serum Interleukin-6 (IL-6) Concentration
A pro-inflammatory cytokine measured in serum using a commercial ELISA kit (BioLegend) to evaluate the inflammatory response. Unit of Measure: Picograms per milliliter (pg/mL)
Measured: 7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.
Malondialdehyde (MDA) Levels
A standard biomarker of lipid peroxidation. Serum MDA levels are determined using a commercial ELISA kit to assess oxidative stress status. Unit of Measure: micromolar (μM)
Measured: 7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.
Serum Creatine Kinase (CK) Concentration
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: 7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.
Carbohydrate (CHO) Oxidation Rate
Determined using VO 2 and VCO 2 data collected during the cycling challenge. Calculated using the equation: 4.585×VCO2 -3.226×VO2 .
Unit of Measure: grams per minute (g/min)
Measured: 7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.
Fat Oxidation Rate
Determined using VO 2 and VCO 2 data collected during the cycling challenge. Calculated using the Frayn equation: 1.695×VO 2 -1.701×VCO 2 .
Unit of Measure: grams per minute (g/min)
Measured: 7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.
Respiratory Exchange Ratio (RER)
Calculated as the ratio of carbon dioxide production ($VCO_2$) to oxygen consumption ($VO_2$). It reflects the relative contribution of carbohydrates and fats to energy metabolism.
Unit of Measure: Ratio (Unitless)
Measured: 7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.
Maximal Oxygen Consumption (VO2max)
Measured using a graded exercise test on a stationary ergometer. VO2max is defined as the plateau in oxygen uptake despite an increase in workload, confirmed when at least two of the following criteria are met: (1) RER > 1.10, (2) VO2 plateau (< 2 ml/kg/min change), or (3) attainment of age-predicted maximum heart rate.
Unit of Measure: ml/kg/min
Measured: Baseline and at the end of the 4-week crossover period.
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: Measured immediately after each cycling challenge at baseline and at the end of the 4-week crossover trial.
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: Measured immediately after each cycling challenge at baseline and at the end of the 4-week crossover trial.
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: Measured immediately after each cycling challenge at baseline and at the end of the 4-week crossover trial.
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: Measured immediately after each cycling challenge at baseline and at the end of the 4-week crossover trial.
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: Measured immediately after each cycling challenge at baseline and at the end of the 4-week crossover trial.
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: Measured immediately after each cycling challenge at baseline and at the end of the 4-week crossover trial.
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: Measured immediately after each cycling challenge at baseline and at the end of the 4-week crossover trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start21 Apr 2023
- Primary completion1 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- The study recruited 14 healthy adult, all of whom engage in regular physical training. Participants were crossed over for Pine bark extract or placebo supplements, which could be ended in two days.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, China Medical University, Taiwan
- Responsible party
- Sponsor
- Investigators
- Jung-Piao Tsao, Study chair, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440394
- Sponsor's protocol ID
- CMUH111-REC2-173
- Status last verified
- Feb 2026
- First submitted
- 27 Jul 2025
- Last updated
- 27 Feb 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pine Bark Extract for Anti-fatigue Ergogenic Properties
- ClinicalTrials.gov ID
- NCT07440394
- Acronym / sponsor ID
- CMUH111-REC2-173
- Conditions
- Healthy
- Keywords
- pine bark extract, exercise performance, Maximal oxygen consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, China Medical University, Taiwan
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Feb 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.
This research proposal aims to elucidate the physiological responses to pine bark extract supplementation during a single bout of high-intensity cycling exercise at 70% VO₂max and the subsequent recovery phase. Specifically, the study seeks to investigate the underlying mechanisms by which pine bark extract modulates exercise-induced fatigue and metabolic fitness, and to determine whether such supplementation may enhance endurance performance in the post-recovery period.
Detailed description
The primary active component of natural pine bark extract (PBE) is proanthocyanidins, which possess antioxidant, anti-inflammatory, and endothelial function-enhancing properties. These attributes suggest its potential as an ergogenic aid to improve exercise performance. In this study, 14 healthy participants will be randomly assigned to receive either 300 mg/day of PBE or a placebo for 4 consecutive days. Following supplementation, participants will consume a low-calorie meal (300 kcal) accompanied by either the placebo or PBE and rest for one hour. One hour after capsule ingestion, participants will perform a 60-minute cycling exercise at 70% VO₂max. Upon completion of the exercise challenge, they will consume a post-exercise meal adjusted to body weight. After a 3-hour recovery period, subjects will undergo an anaerobic power test followed by an endurance test at 75% VO₂max to volitional exhaustion. Gas exchange and blood samples will be collected at multiple time points: pre- and post-initial cycling session, during the recovery phase, and following the exhaustive endurance test. Gas samples will be analyzed to determine rates of fat and carbohydrate oxidation. Blood biomarkers will be assessed for glucose, superoxidase dismutase (SOD), malondialdehyde (MDA), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), creatine kinase (CK), lactate dehydrogenase (LDH), and uric acid (UA).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study recruited 14 healthy adult, all of whom engage in regular physical training. Participants were crossed over for Pine bark extract or placebo supplements, which could be ended in two days.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo (Placebo trial), Other: PBE (PBE trial)Containing edible yellow No. 4, edible yellow No. 5, sucrose, silica, talc, oxidized starch, gelatin, magnesium stearate, and palm wax. |
| PBE | Experimental | Other: Placebo (Placebo trial), Other: PBE (PBE trial)Each capsule containing 100 mg of Pycnogenol®, Taiwan |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- A minimum of three years of regular exercise habits.
Key exclusion criteria (4 listed)
- Have smoking and drinking habits.
- People who feel unwell due to other reasons during the experiment.
- Individuals with respiratory disorders.
- Severe lower limb musculoskeletal injuries within the past six months.
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 |
|---|---|---|
| Placebo (Placebo trial)The Placebo capsule supplement was taken for 4 days (3 capsules per day) | Other | PBE, Placebo |
| PBE (PBE trial)The PBE capsule supplement was taken for 4 days, with a daily dosage of 300 mg of PBE (equivalent to 3 capsules per day, each containing 100 mg of PBE). | Other | PBE, Placebo |
Primary outcome
Time to Exhaustion (TTE)
Time frame: Baseline and at the end of the 4-week crossover period.
The total duration (in minutes) from the start of the graded exercise test until the participant reaches volitional exhaustion or can no longer maintain the required cadence of 60 RPM. Unit of Measure: Minutes
19 secondary outcomes
Serum Tumor Necrosis Factor-alpha (TNF-alpha) Concentration
Time frame: 7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.
Superoxide Dismutase (SOD) Activity
Time frame: 7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.
Blood Glucose Levels
Time frame: 7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.
Uric Acid (UA) Levels
Time frame: 7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.
Lactate Dehydrogenase (LDH) Activity
Time frame: 7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.
Serum Interleukin-6 (IL-6) Concentration
Time frame: 7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.
Malondialdehyde (MDA) Levels
Time frame: 7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.
Serum Creatine Kinase (CK) Concentration
Time frame: 7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.
Carbohydrate (CHO) Oxidation Rate
Time frame: 7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.
Fat Oxidation Rate
Time frame: 7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.
Respiratory Exchange Ratio (RER)
Time frame: 7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.
Maximal Oxygen Consumption (VO2max)
Time frame: Baseline and at the end of the 4-week crossover period.
Profile of Mood States (POMS) - Vigor Subscale Score
Time frame: Measured immediately after each cycling challenge at baseline and at the end of the 4-week crossover trial.
Profile of Mood States (POMS) - Self-esteem Subscale Score
Time frame: Measured immediately after each cycling challenge at baseline and at the end of the 4-week crossover trial.
Profile of Mood States (POMS) - Tension Subscale Score
Time frame: Measured immediately after each cycling challenge at baseline and at the end of the 4-week crossover trial.
Profile of Mood States (POMS) - Confusion Subscale Score
Time frame: Measured immediately after each cycling challenge at baseline and at the end of the 4-week crossover trial.
Profile of Mood States (POMS) - Anger Subscale Score
Time frame: Measured immediately after each cycling challenge at baseline and at the end of the 4-week crossover trial.
Profile of Mood States (POMS) - Fatigue Subscale Score
Time frame: Measured immediately after each cycling challenge at baseline and at the end of the 4-week crossover trial.
Profile of Mood States (POMS) - Depression Subscale Score
Time frame: Measured immediately after each cycling challenge at baseline and at the end of the 4-week crossover trial.
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 27 Feb 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 PBE (PBE trial) in people with Healthy, 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 4 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 27 Feb 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. Some participants in this study may receive a placebo. 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?
Time to Exhaustion (TTE) (time frame: Baseline and at the end of the 4-week crossover period.). 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 27 Feb 2026.