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临床试验/NCT07518355
NCT07518355已完成不适用

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

China Medical University Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年10月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
40 km cycling time trial

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Placebo

Placebo Comparator

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

干预措施: Placebo (Placebo trial) (Other)

Placebo

Placebo Comparator

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

干预措施: Rutin (Rutin trial) (Other)

Rutin

Experimental

Each capsule containing 500 mg of rutin

干预措施: Placebo (Placebo trial) (Other)

Rutin

Experimental

Each capsule containing 500 mg of rutin

干预措施: Rutin (Rutin trial) (Other)

结局指标

主要结局

40 km cycling time trial

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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