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

NCT07518355 | Completed

• 1 other identifier: CMUH113-REC3-119
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

rutin; Ergogenic aids; Oxidative stress; 40km time trial

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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).

  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).

  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)

  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).

  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)

  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)

  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)

  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).

  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).

  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).

  14 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Containing edible yellow No. 4, edible yellow No. 5, sucrose, silica, talc, oxidized starch, gelatin, magnesium stearate, and palm wax.

Other: Placebo (Placebo trial); Other: Rutin (Rutin trial)

Rutin

EXPERIMENTAL

Each capsule containing 500 mg of rutin

Other: Placebo (Placebo trial); Other: Rutin (Rutin trial)

Interventions

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).

Placebo; Rutin

Placebo (Placebo trial) OTHER

The placebo capsule supplement was taken for 14 days (4 capsules per day)

Placebo; Rutin

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Recruit people who are healthy are 18-25 years male and have regular exercise habits in college students

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead
• National Science and Technology Council: collaborator
• China Medical University, China: collaborator

Study Sites (1)

China Medical University

Taichung, 404332, Taiwan

Location

MeSH Terms

Interventions

Rutin

Intervention Hierarchy (Ancestors)

Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jung-Piao Tsao

  China Medical University, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: April 8, 2026
• Study Start: October 30, 2024
• Primary Completion: January 22, 2025
• Study Completion: February 17, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)