Dehydration, Rehydration, and Impact on Physiology

NCT ID: NCT07084675

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2026-12-31

Brief Summary

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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)

Detailed Description

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Conditions

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Aging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Hydration-Dehydration-Rehydration (HDR) Protocol Arm

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

Group Type EXPERIMENTAL

Hydration-Dehydration-Rehydration Protocol (HDR)

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Texas Tech University

OTHER

Sponsor Role lead

Responsible Party

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Hui Ying Luk

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Texas Tech University

Lubbock, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Hui Ying Luk, Ph.D.

Role: CONTACT

806-834-0827

Facility Contacts

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Hui Ying Luk, Ph.D.

Role: primary

806-834-0827

Other Identifiers

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IRB2025-288

Identifier Type: -

Identifier Source: org_study_id

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