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临床试验/NCT02726516
NCT02726516已完成不适用

Effects of PRJ-205 on Performance in Trained Young Subjects After Acute and Chronic Intake of the Study Product

Bioiberica1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年3月1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
发起方
入组人数
20
试验地点
1
主要终点
Aerobic performance determined by VO2max

研究概览

简要总结

Compare a dietary supplement (PRJ-205) and placebo during 1 or 4 days on aerobic exercise performance, oxidative stress and muscle damage.

The hypothesis is that supplementation with PRJ-205 improve aerobic performance

详细描述

Twenty young active males will be recruited and randomized to either placebo or PRJ-205. Subjects will take the designated treatment in an acute dosage and chronically, 4 days of treatment.

They will undergo 3 exercise tasks (before the administration of the product, 1.5h after the acute administration of the product and after 4 days of treatment). VO2max and anaerobic threshold will be measured during the tests. Blood samples will be taken to measure muscle damage and oxidative stress.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Physically active

排除标准

  • •known cardiovascular, pulmonary or metabolic disease
  • •any medical condition that could affect the development and safety of the exercise task

研究组 & 干预措施

Treated

Experimental

Treated volunteers will be administered one dose of PRJ-205 1,5 hours before the exercise task for the acute testing and will be taking one dose per day of PRJ-205 for 4 days for the chronic testing.

干预措施: PRJ-205 (Dietary Supplement)

Placebo

Placebo Comparator

Placebo volunteers will be administered one dose of placebo 1,5 hours before the exercise task for the acute testing and will be taking one dose per day of placebo for 4 days for the chronic testing.

干预措施: Placebo (Other)

结局指标

主要结局

Aerobic performance determined by VO2max

时间窗: 4 days

次要结局

  • Pressure pain threshold of calf muscle(4 days)
  • Serum markers of muscular damage(4 days)
  • Oxidative stress parameters(4 days)

研究者

发起方
Bioiberica
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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