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Completed

NCT Number: NCT07518355

Effects of Rutin on Oxidative Stress, Inflammatory Markers, and Blood Flow Velocity During Cycling 40km Time Trial Performance

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.

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Key information

Conditions

Healthly Volunteers

Age range

18 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University

Taichung, 404332, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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)

  6. 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).

  7. 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)

  8. 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)

  9. 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)

  10. 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).

  11. 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).

  12. 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).

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Collaborators

  • China Medical University, China
  • National Science and Technology Council

Registry information

Official study title

Effects of Rutin on Oxidative Stress, Inflammatory Markers, and Blood Flow Velocity During Cycling 40km Time Trial Performance: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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