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临床试验/NCT01714479
NCT01714479已完成不适用

Skeletal Muscle and Physical Performance Responses to Leucine-Enriched Nutrition Supplementation During Load Carriage

United States Army Research Institute of Environmental Medicine2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年10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
40
试验地点
2
主要终点
Change in muscle protein synthesis and whole-body protein turnover during and after load carriage or conventional exercise with or without amino acid supplementation

研究概览

简要总结

Warfighters often experience physical overload, as the uniform and associated gear that they carry burdens them with substantial loads. The loads increase energy expenditure to levels that exceed a Warfighter's typical energy intake. The typical assault load is approximately 25 kg, although loads as high as 55 kg are often carried, which when combined with extreme energy expenditures can degrade health and performance, and increase the risk of injury. Branched-chain amino acid (leucine) supplementation may confer protection against the negative effects of operational stress by stimulating muscle protein synthesis and reducing degradation. This study will determine if leucine-enriched nutrition supplementation confers protection against the negative consequences of sustained load carriage exercise, and explore the mechanisms by which leucine might impart protection.

研究设计

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

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Weight stable (±5 lbs)with a body mass index between 22-29 kg/m2 and a VO2peak of 40 - 60 ml/kg/min
  • Willing to refrain from taking any NSAIDS (i.e., aspirin, Advil®, Aleve®, Naprosyn®), or any aspirin-containing products, alchohol, and nicotine
  • Females must be on oral contraception

排除标准

  • Metabolic or cardiovascular abnormalities, gastrointestinal disorders
  • Disease or medication that affects macronutrient metabolism or the ability to participate in strenuous exercise
  • Allergies or intolerance to foods (e.g. lactose intolerance/milk allergy), vegetarian practices, or medications (including, but not limited to, lidocaine or phenylalanine) to be used in the study
  • Anemia (HCT <38) and Sickle Cell Anemia/Trait, abnormal PT/PTT test or problems with blood clotting
  • Present condition of alcoholism, use of nutritional/sports supplements, anabolic steroids, or other substance abuse issues
  • Musculoskeletal injuries that compromise the ability to exercise
  • Blood donation within 8 weeks of enrollment
  • Pregnancy and women not on oral contraceptives

研究组 & 干预措施

Load Carriage - Control

Placebo Comparator

Load Carriage - with a calorie-free placebo

干预措施: Placebo (Other)

Load Carriage - leucine-enriched nutrition supplement

Experimental

Load Carriage with leucine-enriched amino acid supplementation

干预措施: Leucine-enriched nutritional supplement (Other)

Conventional Exercise - Control

Placebo Comparator

Conventional Exercise with a calorie-free placebo

干预措施: Placebo (Other)

Conventional Exercise - Leucine-enriched Nutrition Supplement

Active Comparator

Conventional Exercise with leucine-enriched Amino Acid supplementation

干预措施: Leucine-enriched nutritional supplement (Other)

结局指标

主要结局

Change in muscle protein synthesis and whole-body protein turnover during and after load carriage or conventional exercise with or without amino acid supplementation

时间窗: 90 min exercise bout (exercise) and 180 min of recovery

次要结局

  • Changes in muscle performance in recovery from load carriage or conventional exercise with or without amino acid supplementation(4, 24, 48, and 72 hours post exercise)

研究者

发起方
United States Army Research Institute of Environmental Medicine
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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