Healthly VolunteersNCT07518355
Effects of Rutin on Oxidative Stress, Inflammatory Markers, and Blood Flow Velocity During Cycling 40km Time Trial Performance
A study testing Rutin (Rutin trial) in people with Healthly Volunteers, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Background: Rutin has several health benefits like improving total antioxidant capacity(TAC), inducing more nitric oxide(NO) produced from endothelium, and anti-inflammatory. Studies show rutin can enhance sport performance in mouse, but there isn't any human trail suggests that rutin can improve sport performance in… Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthly Volunteers
- What is being tested?
- Rutin (Rutin trial)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Oct 2024to 17 Feb 2025
- 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 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recruit people who are healthy are 18-25 years male and have regular exercise habits in college students
Who cannot join
- Have smoking and drinking habits.
- Those who have implanted artificial joints in the past six months and have had recent surgery.
- People who feel unwell due to other reasons during the experiment.
- Take any drugs or Nutrition supplements in the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Rutin on Oxidative Stress, Inflammatory Markers, and Blood Flow Velocity During Cycling 40km Time Trial Performance: A Randomized Controlled Trial
Background: Rutin has several health benefits like improving total antioxidant capacity(TAC), inducing more nitric oxide(NO) produced from endothelium, and anti-inflammatory. Studies show rutin can enhance sport performance in mouse, but there isn't any human trail suggests that rutin can improve sport performance in high-stressed state. Purpose: This study want to investigated the effects of rutin on oxidative stress, inflammatory markers, and blood flow velocity in 40km time trial. Method: A single-blinded crossover placebo-controlled study design is used and rutin supplementation is compared to a non-treatment control group. Twelve subjects are randomly assigned into two groups supplemented with the dose of 2000mg/day rutin or placebo for two weeks. All subjects participate 40km cycling time trails(TT) after rutin or placebo supplement. Venous blood samples are drawn before meal, before exercise and immediately after the exercise in order to estimate malondialdehyde(MDA) levels, TAC, Interleukin 10(IL-10), tumor necrosis factor-alpha(TNF-a), and high-sensitivity C-reactive protein(HS-CRP). In TT, blood flow velocity is monitored by near infrared spectroscopy(NIRS) and HR rating of perceived exertion(RPE) and rating-of-fatigue (ROF) scale are also recorded. Expected results:14 days rutin supplementation can improve 40km TT performance by reducing exercise-induced oxidative stress and enhancing blood flow velocity in healthy young adults.
- Conditions
- Healthly Volunteers
- Being tested
- Placebo (Placebo trial), Rutin (Rutin trial)
- Keywords
- rutin, Ergogenic aids, Oxidative stress, 40km time trial
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 14 days (4 capsules per day)
Rutin (Rutin trial)Other
The rutin capsule supplement was taken for 14 days, with a daily dosage of 2000 mg of rutin (equivalent 4 to capsules per day, each containing 500 mg of rutin).
| 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: Rutin (Rutin trial) |
| Rutin | Experimental | Each capsule containing 500 mg of rutin Receives: Other: Placebo (Placebo trial); Other: Rutin (Rutin trial) |
What is being measured
The primary outcome is the main question the study is designed to answer.
40 km cycling time trial
Investigators conducted a double-blind test, where volunteers' basal maximal oxygen consumption (VO2max) was measured both before the intervention. The pretest VO2max is a reference to adjust the exercise intensity for each individual. To assess volunteers' aerobic endurance capacity by 40km cycling time trail(40km TT), participants exercised at 55% VO2max, and the cycling time from the start to 40km was recorded.
Measured: 14 days
Near infrared spectroscopy
Near infrared spectroscopy(NIRS)(Moxy, Fortiori Design LLC, Minnesota, USA) can non-invasively observe blood oxygenation and blood flow through infrared light. Before the exercise, NIRS was fixed on the subject's thigh. During 40km time trial, blood flow velocity was collected by NIRS.
Measured: 14 days
Rating-of-fatigue (ROF) scale
The Rating of Fatigue Scale measures perceived fatigue during or after exercise. Participants rate fatigue from 0 (no fatigue) to 10 (extreme fatigue). A higher score indicates greater fatigue (worse condition).
Measured: 14 days
The Borg Rating of Perceived Exertion(RPE) Scale
The Borg Rating of Perceived Exertion Scale measures how hard exercise feels. Participants rate effort from 6 (no exertion) to 20 (maximal exertion). A higher score means greater effort (worse fatigue).
Measured: 14 days
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: 14 days
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: 14 days
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: 14 days
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: 14 days
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: 14 days
High-sensitivity C-reactive Protein(HS-CRP) Concentration
A biomarker of inflammation measured in serum using enzyme-linked immunosorbent assay (ELISA) with a microplate reader. Unit of Measure: milligrams per liter (mg/L).
Measured: 14 days
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: 14 days
Serum Interleukin-10 (IL-10) Concentration
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: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start30 Oct 2024
- Primary completion22 Jan 2025
- Study completion17 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthly VolunteersStudies 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
- Twelve young healthy physically active male college students. Participants were crossed over for rutin or placebo supplements, which was completed in fourteen days. Between the crossover trials, participants had a two-week washout period to nullify the effects of the supplement.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, China Medical University, China
- Responsible party
- Sponsor
- Investigators
- Jung-Piao Tsao, Study chair, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518355
- Sponsor's protocol ID
- CMUH113-REC3-119
- Status last verified
- Apr 2026
- First submitted
- 20 Jul 2025
- Last updated
- 8 Apr 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 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rutin on Oxidative Stress, Inflammatory Markers, and Blood Flow Velocity During Cycling 40km Time Trial Performance: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07518355
- Acronym / sponsor ID
- CMUH113-REC3-119
- Conditions
- Healthly Volunteers
- Keywords
- rutin, Ergogenic aids, Oxidative stress, 40km time trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, China Medical University, China
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 8 Apr 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.
Background: Rutin has several health benefits like improving total antioxidant capacity(TAC), inducing more nitric oxide(NO) produced from endothelium, and anti-inflammatory. Studies show rutin can enhance sport performance in mouse, but there isn't any human trail suggests that rutin can improve sport performance in high-stressed state. Purpose: This study want to investigated the effects of rutin on oxidative stress, inflammatory markers, and blood flow velocity in 40km time trial. Method: A single-blinded crossover placebo-controlled study design is used and rutin supplementation is compared to a non-treatment control group. Twelve subjects are randomly assigned into two groups supplemented with the dose of 2000mg/day rutin or placebo for two weeks. All subjects participate 40km cycling time trails(TT) after rutin or placebo supplement. Venous blood samples are drawn before meal, before exercise and immediately after the exercise in order to estimate malondialdehyde(MDA) levels, TAC, Interleukin 10(IL-10), tumor necrosis factor-alpha(TNF-a), and high-sensitivity C-reactive protein(HS-CRP). In TT, blood flow velocity is monitored by near infrared spectroscopy(NIRS) and HR rating of perceived exertion(RPE) and rating-of-fatigue (ROF) scale are also recorded. Expected results:14 days rutin supplementation can improve 40km TT performance by reducing exercise-induced oxidative stress and enhancing blood flow velocity in healthy young adults.
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
- Twelve young healthy physically active male college students. Participants were crossed over for rutin or placebo supplements, which was completed in fourteen days. Between the crossover trials, participants had a two-week washout period to nullify the effects of the supplement.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo (Placebo trial), Other: Rutin (Rutin trial)Containing edible yellow No. 4, edible yellow No. 5, sucrose, silica, talc, oxidized starch, gelatin, magnesium stearate, and palm wax. |
| Rutin | Experimental | Other: Placebo (Placebo trial), Other: Rutin (Rutin trial)Each capsule containing 500 mg of rutin |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Recruit people who are healthy are 18-25 years male and have regular exercise habits in college students
Key exclusion criteria (4 listed)
- Have smoking and drinking habits.
- Those who have implanted artificial joints in the past six months and have had recent surgery.
- People who feel unwell due to other reasons during the experiment.
- Take any drugs or Nutrition supplements in the past 3 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 14 days (4 capsules per day) | Other | Placebo, Rutin |
| Rutin (Rutin trial)The rutin capsule supplement was taken for 14 days, with a daily dosage of 2000 mg of rutin (equivalent 4 to capsules per day, each containing 500 mg of rutin). | Other | Placebo, Rutin |
Primary outcome
40 km cycling time trial
Time frame: 14 days
Investigators conducted a double-blind test, where volunteers' basal maximal oxygen consumption (VO2max) was measured both before the intervention. The pretest VO2max is a reference to adjust the exercise intensity for each individual. To assess volunteers' aerobic endurance capacity by 40km cycling time trail(40km TT), participants exercised at 55% VO2max, and the cycling time from the start to 40km was recorded.
Near infrared spectroscopy
Time frame: 14 days
Near infrared spectroscopy(NIRS)(Moxy, Fortiori Design LLC, Minnesota, USA) can non-invasively observe blood oxygenation and blood flow through infrared light. Before the exercise, NIRS was fixed on the subject's thigh. During 40km time trial, blood flow velocity was collected by NIRS.
Rating-of-fatigue (ROF) scale
Time frame: 14 days
The Rating of Fatigue Scale measures perceived fatigue during or after exercise. Participants rate fatigue from 0 (no fatigue) to 10 (extreme fatigue). A higher score indicates greater fatigue (worse condition).
The Borg Rating of Perceived Exertion(RPE) Scale
Time frame: 14 days
The Borg Rating of Perceived Exertion Scale measures how hard exercise feels. Participants rate effort from 6 (no exertion) to 20 (maximal exertion). A higher score means greater effort (worse fatigue).
Serum Tumor Necrosis Factor-alpha (TNF-alpha) Concentration
Time frame: 14 days
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)
Superoxide Dismutase (SOD) Activity
Time frame: 14 days
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).
Lactate Dehydrogenase (LDH) Activity
Time frame: 14 days
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)
Serum Creatine Kinase (CK) Concentration
Time frame: 14 days
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)
Malondialdehyde (MDA) Levels
Time frame: 14 days
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)
High-sensitivity C-reactive Protein(HS-CRP) Concentration
Time frame: 14 days
A biomarker of inflammation measured in serum using enzyme-linked immunosorbent assay (ELISA) with a microplate reader. Unit of Measure: milligrams per liter (mg/L).
Uric Acid (UA) Levels
Time frame: 14 days
Measured in serum as a marker of metabolic stress and muscle damage using commercial analytical reagents. Unit of Measure: Milligrams per deciliter (mg/dL).
Serum Interleukin-10 (IL-10) Concentration
Time frame: 14 days
Measured in serum as a marker of metabolic stress and muscle damage using commercial analytical reagents. Unit of Measure: Milligrams per deciliter (mg/dL).
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 8 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Healthly Volunteers
Not yet recruiting
A Two-Way Path to Health: Environmental Influences on Skeletal Muscle Endocrine Function
Healthly Volunteers, Oncologic Disease
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 Rutin (Rutin trial) in people with Healthly Volunteers, 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 8 Apr 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?
40 km cycling time trial (time frame: 14 days). The study lists 12 primary outcomes in all. 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 8 Apr 2026.