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NCT Number: NCT07084675

Dehydration, Rehydration, and Impact on Physiology

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)

Recruiting

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Key information

Conditions

Aging

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Tech University

Lubbock, Texas, 79409, United States

Location status: Recruiting

Location contact

Hui Ying Luk, Ph.D.

CONTACT

[email protected]

806-834-0827

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Hydration-Dehydration-Rehydration Protocol (HDR)

Behavioral

The 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.

Primary outcomes

  1. Fasting blood glucose (mg/dL)

    Time frame: 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.

  2. Total body water (L)

    Time frame: 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.

  3. Intracellular water (L)

    Time frame: 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.

  4. Extracellular water (L)

    Time frame: 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.

  5. Hand grip strength (kg)

    Time frame: 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.

  6. Isometric leg pull strength (kg)

    Time frame: 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.

  7. Total sleep time (hrs)

    Time frame: through study completion, 18 days

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

  8. Sleep efficiency (%)

    Time frame: through study completion, 18 days

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

  9. Number of awakenings (count)

    Time frame: through study completion, 18 days

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

  10. PBMC H2O2 ( µg/mL)

    Time frame: 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.

  11. DRP1 (Arbitrary Units)

    Time frame: 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).

  12. MFN (Arbitrary Units)

    Time frame: 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.

  13. PINK1 (Arbitrary Units)

    Time frame: 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.

  14. Parkin (Arbitrary Units)

    Time frame: 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.

  15. Malondialdehyde (nmol/mg)

    Time frame: 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.

Secondary outcomes

  1. Change in hydration status via urine specific gravity (USG)

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

    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.

  2. Total lean mass (g)

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

    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.

  3. Total fat mass (g)

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Ying Luk, Ph.D.

CONTACT

[email protected]

806-834-0827

Sponsors and collaborators

Lead sponsor

Texas Tech University

Other

Registry information

Official study title

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

Acronym: DRIP

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 24, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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