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临床试验/NCT02385357
NCT02385357Unknown早期 1 期

Effect of a Protein-enriched Drink on Muscle Function Recovery Following an Acute High Intensity Exercise Bout

Puleva Biotech2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年2月1日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
发起方
入组人数
12
试验地点
2
主要终点
Isometric muscle strength

研究概览

简要总结

There is no conclusive evidence about the effect of intake of protein-enriched drink after and acute high intensity exercise bout on muscle function and damage. The investigators aimed to study the effect of a protein-enriched drink on muscle function recovery following an acute high intensity exercise bout. The present counterbalanced, crossover, and double blind study will involve a total of 12 active men.

详细描述

Participants will run downhill (-10%) during 30 min at a intensity equivalent to 75-80% of their maximum heart rate (previously determined). After the exercise bout, participants will have either the placebo or the experimental drink. The investigators will measure muscle function and damage-related parameters right after the exercise as well as the three following days. This protocol will be repeated after a wash out period of 3 weeks, where the participants will have the other drink. The investigators will control exercise and diet three weeks before study entry, during the experimental week as the investigators as during the wash out period.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Recreational triathletes with 2 years of experience
  • Maximum oxygen uptake : ≥55 ml/kg/min
  • Fat mass: 8-20% measured by dual energy x-ray absorptiometry
  • Not participating in another study
  • Not having ergogenic aids
  • Not participating in a weight loss program
  • Normal electrocardiogram
  • Participants must be capable and willing to provide consent, understand

排除标准

  • and accept the randomized group assignment
  • Exclusion Criteria:
  • History of cardiovascular disease
  • Diabetes or hypertension
  • Medication for hypertension, hyperlipidemia, hyperuricemia or other illness.
  • Other significant medical conditions that are life-threatening or that can interfere with or be aggravated by exercise.
  • Unwillingness to either complete the study requirements or to be randomized into control or training group.

研究组 & 干预措施

Control

Placebo Comparator

330 ml of commercial protein-enriched drink (2.5 g/100 ml of protein)

Experimental

Experimental

330 ml of protein-enriched drink (6 g/100 ml of protein)

干预措施: Protein-enriched drink (Dietary Supplement)

结局指标

主要结局

Isometric muscle strength

时间窗: Change from pre- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink

Isometric muscle strength of lower limbs at 90% angle.

次要结局

  • Power output assessed with the 30sec. Wingate anaerobic test(Change from post- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink)
  • Urine Creatinine(Change from post- protein-enriched drink to 24, 48 hrs post- protein-enriched drink)
  • Resting metabolic rate(Change from pre- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink)
  • Creatine kinase(Change from post- protein-enriched drink to 24, 48 hrs post- protein-enriched drink)
  • Muscle soreness of lower limbs self-reported by a visual anagogic scale and with an algometer score.(Change from post- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink)
  • Time limit (time that the participant is able to run 90% of his determined maximum aerobic velocity)(24hrs after protein-enriched drink)

研究者

发起方
Puleva Biotech
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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