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临床试验/NCT04090138
NCT04090138已完成不适用

The Effect of Setria Performance Blend on Endurance Performance

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Change in Blood Flow (ml/min-1)

研究概览

简要总结

The objective of this trial is to evaluate the effects of setria performance blend supplementation on endurance performance in healthy men.

详细描述

This study is a randomized, double-blind, placebo-controlled crossover trial in healthy men. Subjects will take either a placebo or setria performance blend (L-citrulline + glutathione) for 8 days. At the day 8, subjects run on the treadmill to measure the time to exhaustion at 90%, 100%, and 110% of peak velocity. Arterial blood flow and blood vessel diameter (via ultrasound), blood analytes (plasma nitrate/nitrite, L-arginine, L-citrulline), subjective feelings of fatigue from a visual analog scale (VAS) and ratings of perceived exertion will be assessed. There is a minimum of a two week washout period in between trials/treatments. The same procedures are completed upon return visit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Each subject and their associated information will be identified by a 4-digit alpha-numerical identification code.

入排标准

年龄范围
20 Years 至 30 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Participant is an adult male between the ages of 20-30 years
  • Participant is aerobically fit, as defined by a VO2max between 42-70 ml*kg/min (determined by the screening test)
  • Participant is not obese (18.5 ≦ BMI < 30 kg/m²)
  • Participant has provided written and dated informed consent to participate in the study
  • Participant is willing and able to comply with the protocol
  • Participant is apparently healthy and free from disease, as determined by a health history questionnaire
  • Participant agrees to refrain from strenuous exercise and alcohol consumption within 24 hours of laboratory visits, and to refrain from caffeine consumption within twelve hours of visits
  • Participant agrees to refrain from using antibacterial mouthwash, chewing gum, and brushing their teeth on the morning of laboratory visits

排除标准

  • Participant has consistently used prescription drugs or ergogenic dietary supplements that may influence study outcomes within eight weeks prior to enrollment, or begins to do so during the study. Potential drugs and supplements include but are not limited to whey protein, creatine, beta-alanine, antihypertensive medications, or anabolic steroids
  • Participant has gained or lost ≥10 lbs in the previous 2 months
  • Participant is enrolled in a separate clinical trial involving diet, exercise, physical activity, or the potential ingestion of an active drug or dietary supplement in the previous 2 months and during this study
  • Participant has participated in a clinical trial within the previous 2 months that includes modifications to their physical and/or diet that may influence study outcomes and during this study
  • Participant has a known allergy or sensitivity to the placebo or active ingredients
  • Participant consumes more than 3 alcoholic drinks per day
  • Participant has used tobacco more than three days per week (on average) in the previous eight weeks
  • Participant has used recreational drugs within the past month, or refuses to abstain from recreational drug use for the entirety of the study

结局指标

主要结局

Change in Blood Flow (ml/min-1)

时间窗: 8 days

Measured from ultrasound before and after 8 days of supplementation

Change in Vessel Diameter (mm)

时间窗: 8 days

Measured from ultrasound before and after 8 days of supplementation

Change in Time to exhaustion (sec)

时间窗: 8 days

Measured from a treadmill run before and after 8 days of supplementation

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 (2)

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