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临床试验/NCT07084675
NCT07084675招募中不适用

Impact of Mild Dehydration and Subsequent Rehydration on Cellular Stress and Physiological Performance

Texas Tech University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年7月15日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
2
主要终点
Fasting blood glucose (mg/dL)

研究概览

简要总结

Our goal is to determine whether hydration status influences inflammation, and overall physiological performance in adults aged 45-65.

Aim 1: The effects of 4-day mild dehydration followed by 4-day rehydration (defined as approximately 2-3% body mass loss) on H2O2, upstream inflammatory signal (NFkB), mitochondrial fragmentation, and autophagy in circulating PBMCs.

Aim 2: The effects of 4-day mild dehydration followed by 4-day rehydration (defined as approximately 2-3% body mass loss) on fasting glucose, sleep performance, and strength performance.

Participant will:

complete a 4-day hydration protocol, followed by a 4-day dehydration protocol, and then a 4-day rehydration protocol.

attend five laboratory visits for testing: Day 1: Informed consent and familiarization Day 2: Pre-hydration testing (before the 4-day hydration protocol) Day 3: Pre-dehydration testing (before the dehyration protocol) Day 4: Post-dehydration testing (after the dehydration protocol) Day 5: Post-rehydration testing (after the rehydration protocol)

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Apparently Healthy
  • BMI < 30 kg/m2
  • Body weight is at least 110 lbs

排除标准

  • Currently pregnant
  • Have Type 1 Diabetes or Type 2 Diabetes
  • Have chronic kidney disease or a history of kidney stones
  • Have hypertension
  • Take medications that can cause fluid retention, such as corticosteroids, chronic use of Nonsteroidal Anti-inflammatory Drugs (NSAIDs), Hormonal Therapies (e.g., estrogen, androgens or anabolic steroids), Antihypertensives, Psychiatric Medications (e.g., Lithium), Vasodilators
  • Take medications that reduce fluid retention: diuretics, and RAAS Inhibitors (e.g., ACE inhibitors and ARBs)

结局指标

主要结局

Fasting blood glucose (mg/dL)

时间窗: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)

Fasting blood glucose will be measured via fingerstick at each testing visit. Values will be used to examine changes in glucose regulation in response to hydration status across the HDR Protocol phases.

Total body water (L)

时间窗: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)

Bioelectrical impedance spectroscopy (BIS) will be used to assess changes in total body water, BIS measurements will be collected at each testing visit to evaluate fluid shifts.

Isometric leg pull strength (kg)

时间窗: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)

Isometric lower body strength will be evaluated using a standardized leg pull test at four timepoints during the HDR Protocol. Results will be used to determine the effect of hydration status on lower body muscular strength.

Intracellular water (L)

时间窗: Time Frame: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)

Description: Bioelectrical impedance spectroscopy (BIS) will be used to assess changes in intracellular water across hydration phases. BIS measurements will be collected at each testing visit to evaluate fluid shifts.

Total sleep time (hrs)

时间窗: through study completion, 18 days

Total sleep time will be continuously monitored throughout the HDR Protocol using a wearable device.

Extracellular water (L)

时间窗: Time Frame: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)

Description: Bioelectrical impedance spectroscopy (BIS) will be used to assess changes in extracellular water across hydration phases. BIS measurements will be collected at each testing visit to evaluate fluid shifts.

Hand grip strength (kg)

时间窗: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)

Handgrip strength will be measured using a handheld dynamometer at four time points during the HDR Protocol. Measurements will be used to assess the impact of hydration status on upper body muscular strength.

PBMC H2O2 ( µg/mL)

时间窗: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)

Peripheral blood mononuclear cells (PBMCs) will be isolated from whole blood samples collected at four time points during the HDR Protocol. H2O2 will be assessed.

DRP1 (Arbitrary Units)

时间窗: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)

Peripheral blood mononuclear cells (PBMCs) will be isolated from whole blood samples collected at four time points during the HDR Protocol. Fission expression (DRP1).

MFN (Arbitrary Units)

时间窗: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)

Peripheral blood mononuclear cells (PBMCs) will be isolated from whole blood samples collected at four time points during the HDR Protocol. Mitochondrial fusion expression (MFN) will be assessed.

PINK1 (Arbitrary Units)

时间窗: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)

Peripheral blood mononuclear cells (PBMCs) will be isolated from whole blood samples collected at four time points during the HDR Protocol. Mitophagy marker (PINK1) will be assessed.

Parkin (Arbitrary Units)

时间窗: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)

Peripheral blood mononuclear cells (PBMCs) will be isolated from whole blood samples collected at four time points during the HDR Protocol. Mitophagy marker (Parkin) will be assessed.

Malondialdehyde (nmol/mg)

时间窗: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)

Peripheral blood mononuclear cells (PBMCs) will be isolated from whole blood samples collected at four time points during the HDR Protocol. Lipid peroxidation will be assessed by measuring malondialdehyde concentrations.

Sleep efficiency (%)

时间窗: through study completion, 18 days

Sleep efficiency will be continuously monitored throughout the HDR Protocol using a wearable device.

Number of awakenings (count)

时间窗: through study completion, 18 days

Number of awakenings will be continuously monitored throughout the HDR Protocol using a wearable device.

次要结局

  • Change in hydration status via urine specific gravity (USG)(Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing))
  • Total lean mass (g)(Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing))
  • Total fat mass (g)(Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hui Ying Luk

Assistant Professor

Texas Tech University

研究点 (2)

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