Menu
Recruiting NCT07084675

Dehydration, Rehydration, and Impact on Physiology

No phase Interventional Aging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hydration-Dehydration-Rehydration Protocol (HDR).
Who it may be relevant to
Registry conditions: Aging. Basic parameters: 45 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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)

Interventions

  • Behavioral 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): Participant

Primary outcome measures

  • 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)]
Secondary outcome measures (3)
  • 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)]
  • 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)]
  • 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)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Texas Tech University — Lubbock

Identifiers

NCT: NCT07084675 · IRB2025-288

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗