Recruiting

Hydration Impact

Sponsor:

Texas Tech University

Code:

NCT07084675

Conditions

Aging

Eligibility Criteria

Sex: All

Age: 45 - 65

Healthy Volunteers: Accepted

Interventions

Hydration-Dehydration-Rehydration Protocol (HDR)

Study Details

Brief summary:

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)

Conditions

Aging

Study ID

NCT07084675

Start date

Jul 15, 2025

Status verified date

Sep, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 65

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Hydration-Dehydration-Rehydration (HDR) Protocol Arm

Participants in this arm complete the HDR Protocol over 12 days and attend five lab visits.

Interventions

Hydration-Dehydration-Rehydration Protocol (HDR)

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 outcome measure

  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • Total sleep time (hrs) [ Time Frame: through study completion, 18 days ]
  • Sleep efficiency (%) [ Time Frame: through study completion, 18 days ]
  • Number of awakenings (count) [ Time Frame: through study completion, 18 days ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Hui Ying Luk, Ph.D.

806-834-0827huiying.luk@ttu.edu

Locations

Texas Tech University

Recruiting

Lubbock, Texas, United States, 79409

Contacts

Hui Ying Luk, Ph.D.

806-834-0827huiying.luk@ttu.edu

More Information

Sponsor

Texas Tech University

Last update posted

Sep 17, 2025

Last verified

Sep, 2025

Keywords

  • rehydration
  • hypohydration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Tech University on 2025-09-17.