- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07518355
Effects of Rutin on Oxidative Stress, Inflammatory Markers, and Blood Flow Velocity During Cycling 40km Time Trial Performance
April 6, 2026 updated by: China Medical University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Taichung, Taiwan, 404332
- China Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Recruit people who are healthy are 18-25 years male and have regular exercise habits in college students
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Containing edible yellow No. 4, edible yellow No. 5, sucrose, silica, talc, oxidized starch, gelatin, magnesium stearate, and palm wax.
|
The placebo capsule supplement was taken for 14 days (4 capsules per day)
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).
|
|
Experimental: Rutin
Each capsule containing 500 mg of rutin
|
The placebo capsule supplement was taken for 14 days (4 capsules per day)
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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14 days
|
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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.
|
14 days
|
|
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).
|
14 days
|
|
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).
|
14 days
|
|
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)
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14 days
|
|
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).
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14 days
|
|
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)
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14 days
|
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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)
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14 days
|
|
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)
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14 days
|
|
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).
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14 days
|
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Uric Acid (UA) Levels
Time Frame: 14 days
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Measured in serum as a marker of metabolic stress and muscle damage using commercial analytical reagents.
Unit of Measure: Milligrams per deciliter (mg/dL).
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14 days
|
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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).
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14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Jung-Piao Tsao, China Medical University, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 30, 2024
Primary Completion (Actual)
January 22, 2025
Study Completion (Actual)
February 17, 2025
Study Registration Dates
First Submitted
July 20, 2025
First Submitted That Met QC Criteria
April 6, 2026
First Posted (Actual)
April 8, 2026
Study Record Updates
Last Update Posted (Actual)
April 8, 2026
Last Update Submitted That Met QC Criteria
April 6, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMUH113-REC3-119
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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