Dehydration, Rehydration, and Impact on Physiology
ConditionAging
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-65
SponsorTexas Tech University
About this trial
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)
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Apparently Healthy
BMI < 30 kg/m2
Body weight is at least 110 lbs
Disqualifiers
Currently pregnant
Have Type 1 Diabetes or Type 2 Diabetes
Have chronic kidney disease or a history of kidney stones
Have hypertension
Trial design
Design model
Single group
Treatments tested in this trial
Hydration-Dehydration-Rehydration Protocol (HDR)
BehavioralThe HDR Protocol is a 12-day, sequential fluid manipulation intervention designed to assess the physiological effects of controlled changes in hydration status. The protocol consists of three consecutive 4-day phases: Hydration Phase (Days 1-4): Participants follow a standardized fluid intake protocol designed to promote and maintain a euhydrated state. Hydration status is monitored using objective measures such as urine specific gravity and body mass. Dehydration Phase (Days 5-8): Participants adhere to a fluid-restriction regimen to induce a hypohydrated state. The level of dehydration is verified through the same hydration status measures to ensure consistent and safe hypohydration. Rehydration Phase (Days 9-12): Participants resume the standardized fluid intake protocol used during the Hydration Phase to restore euhydration. Rehydration effectiveness is confirmed through repeated hydration assessments.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Hydration-Dehydration-Rehydration (HDR) Protocol ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Fasting blood glucose (mg/dL)
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.
Time frame
Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)2
Total body water (L)
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.
Time frame
Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)3
Intracellular water (L)
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.
Time frame
Time Frame: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)4
Extracellular water (L)
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.
Time frame
Time Frame: Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)Secondary outcomes
1
Change in hydration status via urine specific gravity (USG)
Hydration status will be assessed using urine specific gravity (USG) at four time points across the HDR Protocol: prior to the hydration phase, following the hydration phase, after the dehydration phase, and after the rehydration phase. These values will be used to confirm the effectiveness of each fluid manipulation phase.
Time frame
Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)2
Total lean mass (g)
Body composition will be assessed using dual-energy X-ray absorptiometry (DXA) at four time points across the HDR Protocol. Total lean mass will be evaluated in relation to hydration status at each phase.
Time frame
Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)3
Total fat mass (g)
Body composition will be assessed using dual-energy X-ray absorptiometry (DXA) at four time points across the HDR Protocol. Total fat mass will be evaluated in relation to hydration status during each phase.
Time frame
Day 2 (Pre-hydration testing), Day 3 (Pre-dehydration testing), Day 4 (Post-dehydration testing), Day 5 (Post-rehydration testing)Sponsors and contacts
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Source ClinicalTrials.gov