水合状态对静息、轻度及中度运动期间底物氧化的影响
2026年8月25日 更新者：PepsiCo Global R&D
代谢灵活性是指在不同条件下（休息、进食、运动）能够适当切换脂肪和碳水化合物储存以获取能量的能力。代谢灵活性受损（也称为代谢不灵活）被认为是代谢疾病（如2型糖尿病）的潜在原因。长期低液体摄入可能因胰岛素抵抗（一种代谢不灵活的形式）而增加2型糖尿病的风险。此外，低液体摄入已被证明会损害在运动期间切换燃料偏好的能力。
虽然有一些证据表明低液体摄入可能导致代谢灵活性受损，但还需要更多信息。因此，本研究的目的是评估水合状态在不同强度（轻度和中度）休息和运动期间对底物偏好的影响。此外，我们将检查在这些相同条件下，生物性别和月经周期阶段是否影响水合和代谢。
研究概览
地位
主动，不招人
详细说明
针对女性，三臂干预将在卵泡期和黄体期两个阶段完成，共计13次访视，包括医学筛查。
针对男性，三臂干预将完成一次，共计7次访视，包括医学筛查。
针对男性，三臂干预将完成一次，共计7次访视，包括医学筛查。
研究类型
介入性
注册 (估计的)
104
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。
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
- 成人
接受健康志愿者
是的
描述
纳入标准：
- 受试者为男性或女性
- 若为女性，受试者未怀孕（基于自我报告）
- 若为女性，受试者在研究开始时已停止服用避孕药或移除长效可逆避孕措施超过6个月
- 若为女性，受试者月经周期正常（21-35天）
- 若为女性，受试者愿意追踪其月经周期
- 若为女性，受试者拥有兼容用于追踪月经周期（仅女性）和/或可穿戴数据（女性和男性）应用程序的智能手机
- 受试者年龄在18-35岁之间（含）
- 受试者身体质量指数（BMI）介于18.5-25 kg/m²之间
- 受试者至少为休闲活跃者（每周至少进行3天中等强度、间歇性或稳态运动，每次至少60分钟）
- 受试者习惯骑行至少60分钟
- 受试者不吸烟（或已戒烟至少6个月）
- 受试者未服用可能干扰研究的药物（例如利尿剂、泻药或减肥药）
- 受试者无可能干扰研究的健康状况，如一般健康问卷（GHQ）所示，例如心血管、肾脏或代谢疾病
- 受试者未积极参与减肥干预（节食和/或抗肥胖药物）
- 受试者对粘合剂（例如医用胶带）不过敏
- 受试者愿意在访视前24小时内避免饮酒
- 受试者愿意禁食过夜（约8-12小时）
- 受试者愿意在24小时内避免剧烈运动（仅进行轻度体力活动）
- 受试者愿意在必要时剃除贴片或电极部位的毛发
- 受试者愿意在每次实验室访视前一天食用完全相同的食物
- 能够说、写和读英语
- 提供参与研究的书面同意
排除标准：
- 受试者在过去30天内参与过临床试验
- 受试者在过去36个月内参与过任何百事公司的试验
- 受试者存在某种状况或正在服用某种药物，研究者认为这可能会干扰其提供知情同意、遵守研究方案的能力，可能混淆研究结果的解释，或使个人面临不当风险
- 受试者对酒精过敏（抽血时使用酒精预垫）
- 若为女性，受试者正在服用避孕药或使用长效可逆避孕措施
- 若为男性，受试者正在接受激素治疗以改变睾酮水平（注射、透皮贴剂、药丸等）
- 受试者受雇于生产任何与佳得乐产品竞争产品的公司，或其父母、监护人或其他直系亲属受雇于此类公司。如果受试者不确定某公司是否会被视为佳得乐的竞争对手，将被要求在签署知情同意书前告知研究者该其他公司的名称及其与该公司的关系性质。
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：其他
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Part 1- Dehydrated control trial
Fluid restriction during exercise and for remaining 24 hours
|
Perform steady-state cycling exercise for approximately 1 hour at 70-80% of maximal heart rate
24h after exercise trial, following assigned 24h hydration plan, perform indirect calorimetry followed by 30 min of light cycling (~50% VO2 max) then 30 min of moderate-high cycling (~80% VO2 max).
|
|
其他：Part 1 - Euhydrated with water
Euhydrated with water to account for sweat loss and to maintain hydration over 24-hour period
|
Perform steady-state cycling exercise for approximately 1 hour at 70-80% of maximal heart rate
24h after exercise trial, following assigned 24h hydration plan, perform indirect calorimetry followed by 30 min of light cycling (~50% VO2 max) then 30 min of moderate-high cycling (~80% VO2 max).
|
|
实验性的：Part 1 - Euhydrated with electrolyte beverage
Euhydrated with electrolyte beverage (220 mg sodium in 20 oz) to account for sweat loss and to maintain hydration over 24-hour period
|
Perform steady-state cycling exercise for approximately 1 hour at 70-80% of maximal heart rate
24h after exercise trial, following assigned 24h hydration plan, perform indirect calorimetry followed by 30 min of light cycling (~50% VO2 max) then 30 min of moderate-high cycling (~80% VO2 max).
|
|
实验性的：Part 2 - Euhydrated with water and electrolyte beverage
Euhydrated with water and electrolyte beverage to maintain euhydration status over 3-day study period
|
a 2-hour oral glucose tolerance test
|
|
其他：Part 2 - Dehydration
fluid restriction during experimental period (3 days),
|
a 2-hour oral glucose tolerance test
|
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 |
|---|---|---|
|
Respiratory Exchange Ratio
大体时间：Measured over the course of exercise bouts performed during the exercise and experimental trials. Compared across DEH, EUH-H2O, and EUH-Electrolyte arms.
|
Part 1 only.
VCO2 / VO2 measured using indirect calorimetry measured by metabolic cart (Moxus or similar device) while exercising on cycle ergometer.
|
Measured over the course of exercise bouts performed during the exercise and experimental trials. Compared across DEH, EUH-H2O, and EUH-Electrolyte arms.
|
|
Blood glucose levels
大体时间：baseline and 120-minutes following glucose ingestion for both the dehydration and euhydrated interventions
|
Part 2 only. mg/dL
|
baseline and 120-minutes following glucose ingestion for both the dehydration and euhydrated interventions
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
月经分类
大体时间：经过医学筛查且首次研究访视前一个月
|
当前状态（例如，避孕情况、月经周期是否规律等）通过纸质记录或家用月经周期监测套件（Proov）追踪
|
经过医学筛查且首次研究访视前一个月
|
|
Body Mass
大体时间：Exercise - after bladder void at baseline, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. Experimental -after bladder void at baseline, post 10 min rest, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. OGTT- pre & post
|
Part 1 & 2. kg
|
Exercise - after bladder void at baseline, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. Experimental -after bladder void at baseline, post 10 min rest, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. OGTT- pre & post
|
|
Plasma copeptin concentration
大体时间：Exercise trial- Post 10 min rest, pre-exercise bout. Experimental trial- Post 10 min rest, pre indirect calorimetry; post 1st and 2nd 30 min exercise bout; post 20 min rest. OGTT- every 30 min over 2 hour OGTT.
|
Part 1 & 2. pmol/L
|
Exercise trial- Post 10 min rest, pre-exercise bout. Experimental trial- Post 10 min rest, pre indirect calorimetry; post 1st and 2nd 30 min exercise bout; post 20 min rest. OGTT- every 30 min over 2 hour OGTT.
|
|
Plasma osmolality
大体时间：Exercise trial- Post 10 min rest, pre-exercise bout. Experimental trial- Post 10 min rest, pre indirect calorimetry; post 1st and 2nd 30 min exercise bout; post 20 min rest. OGTT- every 30 min over 2 hour OGTT.
|
Part 1 & 2. mOsm/kg
|
Exercise trial- Post 10 min rest, pre-exercise bout. Experimental trial- Post 10 min rest, pre indirect calorimetry; post 1st and 2nd 30 min exercise bout; post 20 min rest. OGTT- every 30 min over 2 hour OGTT.
|
|
Blood glucose
大体时间：At medical screening to determine eligibility. Exercise trial- Post 10 min rest, pre-exercise bout. Experimental trial- Post 10 min rest, pre indirect calorimetry; post 1st and 2nd 30 min exercise bout; post 20 min rest.
|
Part 1. mg/dL
|
At medical screening to determine eligibility. Exercise trial- Post 10 min rest, pre-exercise bout. Experimental trial- Post 10 min rest, pre indirect calorimetry; post 1st and 2nd 30 min exercise bout; post 20 min rest.
|
|
Blood lactate
大体时间：Exercise trial- Post 10 min rest, pre-exercise bout. Experimental trial- Post 10 min rest, pre indirect calorimetry; post 1st and 2nd 30 min exercise bout; post 20 min rest. OGTT- every 30 min over 2 hour OGTT.
|
Part 1 & 2. mmol/L
|
Exercise trial- Post 10 min rest, pre-exercise bout. Experimental trial- Post 10 min rest, pre indirect calorimetry; post 1st and 2nd 30 min exercise bout; post 20 min rest. OGTT- every 30 min over 2 hour OGTT.
|
|
Peripheral blood mononuclear cell (PBMC) mitochondrial function
大体时间：Exercise trial- Post 10 min rest, pre-exercise bout. Experimental trial- Post 10 min rest, pre indirect calorimetry; post 1st and 2nd 30 min exercise bout; post 20 min rest. OGTT- every 30 min over 2 hour OGTT.
|
Part 1 & 2. cells/uL
|
Exercise trial- Post 10 min rest, pre-exercise bout. Experimental trial- Post 10 min rest, pre indirect calorimetry; post 1st and 2nd 30 min exercise bout; post 20 min rest. OGTT- every 30 min over 2 hour OGTT.
|
|
Urine Specific Gravity
大体时间：Exercise Trial-baseline, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. Experimental Trial-baseline, post resting metabolism assessment, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. OGTT- pre & post 2 hour OGTT.
|
Part 1 & 2. au
|
Exercise Trial-baseline, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. Experimental Trial-baseline, post resting metabolism assessment, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. OGTT- pre & post 2 hour OGTT.
|
|
Urine Osmolality
大体时间：Exercise Trial-baseline, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. Experimental Trial-baseline, post resting metabolism assessment, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. OGTT- pre & post 2 hour OGTT
|
Part 1 & 2. mOsm/kg
|
Exercise Trial-baseline, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. Experimental Trial-baseline, post resting metabolism assessment, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. OGTT- pre & post 2 hour OGTT
|
|
Urine mass
大体时间：Exercise Trial-baseline, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. Experimental Trial-baseline, post resting metabolism assessment, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. OGTT- pre & post 2 hour OGTT
|
Part 1 & 2. g
|
Exercise Trial-baseline, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. Experimental Trial-baseline, post resting metabolism assessment, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. OGTT- pre & post 2 hour OGTT
|
|
Urine Color
大体时间：Exercise Trial-baseline, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. Experimental Trial-baseline, post resting metabolism assessment, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. OGTT- pre & post 2 hour OGTT.
|
Part 1 & 2. Scale of 1 (most hydrated) to 7 (most dehydrated)
|
Exercise Trial-baseline, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. Experimental Trial-baseline, post resting metabolism assessment, post 1st and 2nd 30 min exercise sessions, and post 20 min rest. OGTT- pre & post 2 hour OGTT.
|
|
Fat and Carbohydrate Oxidation
大体时间：Exercise Trial- resting metabolism assessed over 30 min rest period pre-exercise bout and exercise metabolism assessed over final 10 min of 1st and 2nd 30min exercise bout. OGTT- the last 30 min of 2 hour OGTT.
|
Part 1 & 2. resting metabolism measured by Cosmed Quark or similar device.
Exercise metabolism measured by Moxus or similar device.
|
Exercise Trial- resting metabolism assessed over 30 min rest period pre-exercise bout and exercise metabolism assessed over final 10 min of 1st and 2nd 30min exercise bout. OGTT- the last 30 min of 2 hour OGTT.
|
|
Energy Expenditure
大体时间：Exercise Trial- resting metabolism assessed over 30 min rest period pre-exercise bout and exercise metabolism assessed over final 10 min of 1st and 2nd 30min exercise bout. OGTT- the last 30 min of 2 hour OGTT.
|
Part 1 & 2. kcal-resting metabolism measured by Cosmed Quark or similar device.
Exercise metabolism measured by Moxus or similar device.
|
Exercise Trial- resting metabolism assessed over 30 min rest period pre-exercise bout and exercise metabolism assessed over final 10 min of 1st and 2nd 30min exercise bout. OGTT- the last 30 min of 2 hour OGTT.
|
|
VO2 peak
大体时间：Assessed at medical screening during a stress test with a 12-lead EKG on a cycle ergometer.
|
Part 1 only.
mL/kg/min measured using indirect calorimetry (Moxus or similar device)
|
Assessed at medical screening during a stress test with a 12-lead EKG on a cycle ergometer.
|
|
Fat and fat-free mass
大体时间：At medical screening to determine body composition
|
Part 1 & Part 2. kg measured using BodPod
|
At medical screening to determine body composition
|
|
Fluid Intake
大体时间：documented by subject on provided log for 24 hours prior to exercise trial, experimental trial, and OGTT. Exercise and Experimental Trial- DEH group restricted from fluid intake. EUH group fluid measured over duration of exercise bout (60 minutes).
|
Part 1 & Part 2. mL
|
documented by subject on provided log for 24 hours prior to exercise trial, experimental trial, and OGTT. Exercise and Experimental Trial- DEH group restricted from fluid intake. EUH group fluid measured over duration of exercise bout (60 minutes).
|
|
Blood Pressure
大体时间：Medical Screening to determine eligibility
|
Part 1 only.
systolic/diastolic (mmHg)
|
Medical Screening to determine eligibility
|
|
Heart Rate
大体时间：At medical screening to determine eligibility. Throughout entire duration of each 90-120 min exercise trial. Throughout entire duration of 120-150 min of each experimental trial.
|
Part 1 only. bpm
|
At medical screening to determine eligibility. Throughout entire duration of each 90-120 min exercise trial. Throughout entire duration of 120-150 min of each experimental trial.
|
|
Standardized Exercise Intensity
大体时间：Every 10 min throughout entire duration of each 60 min exercise trial to reach 70-80% of VO2 max. Every 10 min throughout entire duration of each 60 min experimental trial to reach 50-80% of VO2 max.
|
Part 1 Only. W
|
Every 10 min throughout entire duration of each 60 min exercise trial to reach 70-80% of VO2 max. Every 10 min throughout entire duration of each 60 min experimental trial to reach 50-80% of VO2 max.
|
|
Sweat Rate
大体时间：Throughout entire duration of 60 min exercise bout of exercise trial. Throughout entire duration of 60 min exercise bout of each experimental trial.
|
Part 1 only.
[Body mass loss (kg) + fluid intake (mL)]/Duration of exercise (hr)
|
Throughout entire duration of 60 min exercise bout of exercise trial. Throughout entire duration of 60 min exercise bout of each experimental trial.
|
|
Wearable Sensr Data
大体时间：Continuous data collection over 24 hours from start of exercise trial through completion of experimental trial.
|
Part 1 only.
photoplethysmogram (PPG) waveform data- optical signals obtained from photoplethysmography, which measure blood volume changes in the microvascular bed of tissue.
|
Continuous data collection over 24 hours from start of exercise trial through completion of experimental trial.
|
|
Rate of Perceived Exhaustion
大体时间：Every 10 min throughout entire duration of each (2x) 30 min exercise bout for each exercise trial. Every 10 min throughout entire duration of each (2x) 30 min exercise bout for each experimental trial.
|
Part 1 Only.
Borg scale of rating of perceived exertion.
Rated on a 6-20 scale from No exertion at all to maximal exertion.
|
Every 10 min throughout entire duration of each (2x) 30 min exercise bout for each exercise trial. Every 10 min throughout entire duration of each (2x) 30 min exercise bout for each experimental trial.
|
|
Adverse Events
大体时间：Through study completion. Part 1 only, an average of 3 weeks for males and 8 weeks for females. Part 2 only, an average of 1 week for males and 4 weeks for females. Part 1 & 2, an average of 4 weeks for males and 12 weeks for females.
|
Part 1 & 2. Documented changes in health and symptoms
|
Through study completion. Part 1 only, an average of 3 weeks for males and 8 weeks for females. Part 2 only, an average of 1 week for males and 4 weeks for females. Part 1 & 2, an average of 4 weeks for males and 12 weeks for females.
|
|
RER
大体时间：30 min pre-2 hour OGTT.
|
Part 2 only.
VCO2 / VO2 measured using indirect calorimetry measured by metabolic cart (Moxus or similar device).
|
30 min pre-2 hour OGTT.
|
|
Diet Log
大体时间：documented by subject on provided log for 24 hours prior to exercise trial, experimental trial, and OGTT to confirm similar diets across trial days.
|
Part 1 & 2.
|
documented by subject on provided log for 24 hours prior to exercise trial, experimental trial, and OGTT to confirm similar diets across trial days.
|
|
AUC during OGTT
大体时间：Across 2 hour OGTT at 30 min increments.
|
Part 2 only.
Area under the curve
|
Across 2 hour OGTT at 30 min increments.
|
|
Plasma insulin concentration
大体时间：Across 2 hour OGTT at 30 min increments.
|
Part 2 only. insulin units
|
Across 2 hour OGTT at 30 min increments.
|
|
Continuous Glucose Monitor (CGM) Outputs
大体时间：Throughout study participation, an average of 1 week for males and 4 weeks for females.
|
Part 2 only.
time in range, time above range, time below range
|
Throughout study participation, an average of 1 week for males and 4 weeks for females.
|
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。
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)
2025年11月5日
初级完成 (估计的)
2026年9月1日
研究完成 (估计的)
2026年9月1日
研究注册日期
首次提交
2025年11月24日
首先提交符合 QC 标准的
2025年12月8日
首次发布 (实际的)
2025年12月23日
研究记录更新
最后更新发布 (实际的)
2026年8月27日
上次提交的符合 QC 标准的更新
2026年8月25日
最后验证
2026年8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.