Accelerating Post-exercise Muscle Glycogen Resynthesis in Humans: Impact of Combined Nutrient Intake and Intermittent Pneumatic Compression or Heat Therapy
2021年3月8日 更新者：PepsiCo Global R&D
To determine if modalities designed to improve blood flow combined with post-exercise nutrient intake will improve replenishment of muscle glycogen better than nutrient intake alone.
A secondary objective is to compare the effectiveness of heat therapy and intermittent pneumatic compression on glycogen replenishment.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
26
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Indiana
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West Lafayette、Indiana、美国、47907
- Purdue University, Department of Health & Kinesiology
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 35年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Subjects will be male and female participants in good health
- 18-35 years of age
- Currently performing cardiovascular or intermittent exercise at a moderate to high intensity at least 5 days per week for 60 minutes or longer per day.
- Understanding of the procedures to be undertaken as part of the study
- Willingness to participate in exercise testing and follow instructions provided by the experimenter
- Informed, voluntary, written consent to participate in the study
Exclusion Criteria:
- History of deep vein thrombosis
- Obesity (BMI > 30 kg/m2)
- Hypertension (resting SBP > 140/90 mmHg)
- Smoking
- Pregnant, planning to become pregnant, or lactating
- Supplements containing antioxidants including vitamin C and E and N-acetyl cysteine
- Any medication
- Lactose intolerance
- Participation in another study within the previous 30 days or in a PepsiCo funded study within the past 6 months.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Intermittent pneumatic compression
IPC sleeve device on leg
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From foot to hip/groin on both legs with only 1 leg connected to pneumatic pump for 1 hour
其他名称：
Prolonged intermittent high intensity running (LIST protocol)
Post-exercise, all participants will receive a beverage containing 1.0 g/kg carbohydrate and 0.3 g/kg protein from the mixture of Gatorade Recover Protein Shake and Gatorade Thirst Quencher
Vastus lateralis muscle in the lower thigh will be obtained by the percutaneous needle technique
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实验性的：Heat therapy
Custom water-circulating garment on leg
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Prolonged intermittent high intensity running (LIST protocol)
Post-exercise, all participants will receive a beverage containing 1.0 g/kg carbohydrate and 0.3 g/kg protein from the mixture of Gatorade Recover Protein Shake and Gatorade Thirst Quencher
Vastus lateralis muscle in the lower thigh will be obtained by the percutaneous needle technique
Custom leg garment with one leg heated by circulating hot water approx 40 degrees C, the other leg approx 32 degrees C (thermoneutral) for 1 hour
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Rate of glycogen resynthesis
大体时间：Change from baseline to 1.5 hrs and 3.5 hrs post exercise bout. Biopsy 1 post-exercise pre nutrient intake 1 and compression (IPC) or heat, biopsy 2 post compression or heat, pre-nutrition intake 2, biopsy 3 at 210 min. Higher rate is better.
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Leg skeletal muscle glycogen level assessment using assay kit
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Change from baseline to 1.5 hrs and 3.5 hrs post exercise bout. Biopsy 1 post-exercise pre nutrient intake 1 and compression (IPC) or heat, biopsy 2 post compression or heat, pre-nutrition intake 2, biopsy 3 at 210 min. Higher rate is better.
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Muscle functional recovery: Skeletal muscle function
大体时间：Change from pre-exercise to post-exercise and prior to biopsies and treatments, and 24 hours post exercise. Less fatigue is better.
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Work fatigue (%) of the knee extensors measured using an isokinetic dynamometer
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Change from pre-exercise to post-exercise and prior to biopsies and treatments, and 24 hours post exercise. Less fatigue is better.
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Muscle functional recovery: Perceived muscle soreness
大体时间：Change from pre-exercise to post-exercise and prior to biopsies and treatments, and 24 hours post exercise. Less soreness is better.
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Knee extensor muscle soreness on a visual analog scale (VAS) of 100 mm after stepping on and off a 40 cm (female) or 45 cm (male) box three times
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Change from pre-exercise to post-exercise and prior to biopsies and treatments, and 24 hours post exercise. Less soreness is better.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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mRNA expression of genes involved in regulation of glucose and glycogen metabolism and muscle functional recovery
大体时间：Change from baseline to 1.5 hours and 3.5 hours post exercise bout. Biopsy 1 post-exercise pre- nutrient intake 1 and compression (IPC) or heat, biopsy 2 post compression or heat and pre- nutrition intake 2, biopsy 3 at 210 min. Higher expression better.
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Leg skeletal muscle fiber analysis determined using RT-PCR (Real-time polymerase chain reaction)
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Change from baseline to 1.5 hours and 3.5 hours post exercise bout. Biopsy 1 post-exercise pre- nutrient intake 1 and compression (IPC) or heat, biopsy 2 post compression or heat and pre- nutrition intake 2, biopsy 3 at 210 min. Higher expression better.
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Serum insulin
大体时间：Change from post exercise at same time as biopsy 1 (Time 0), biopsy 2 (1.5 hrs) and biopsy 3 (3.5 hrs)
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Blood test using ELISA kit
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Change from post exercise at same time as biopsy 1 (Time 0), biopsy 2 (1.5 hrs) and biopsy 3 (3.5 hrs)
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Serum Glucose
大体时间：Change from post exercise at same time as biopsy 1 (Time 0), biopsy 2 (1.5 hrs) and biopsy 3 (3.5 hrs
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Blood test using ELISA kit
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Change from post exercise at same time as biopsy 1 (Time 0), biopsy 2 (1.5 hrs) and biopsy 3 (3.5 hrs
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Bruno Roseguini, PhD、Purdue University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年9月19日
初级完成 (实际的)
2019年12月21日
研究完成 (实际的)
2019年12月21日
研究注册日期
首次提交
2020年4月29日
首先提交符合 QC 标准的
2020年4月29日
首次发布 (实际的)
2020年5月1日
研究记录更新
最后更新发布 (实际的)
2021年3月10日
上次提交的符合 QC 标准的更新
2021年3月8日
最后验证
2021年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Compression sleeve的临床试验
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University Hospital, Montpellier终止
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novoGI完全的淋巴瘤 | 结直肠肿瘤 | 子宫内膜异位症 | 克罗恩病 | 结肠炎、溃疡 | 肠息肉病 | 回肠造口术 - 造口 | 肠扭转 | 结肠造口术 | 憩室，结肠 | 直肠脱垂美国
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Calvary Hospital, Bronx, NYNew York State Department of Health; RTS Family Foundation完全的