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AgingDRIPNCT07084675

Dehydration, Rehydration, and Impact on Physiology

A study testing Hydration-Dehydration-Rehydration Protocol (HDR) in people with Aging, run by Texas Tech University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 45 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
Hydration-Dehydration-Rehydration Protocol (HDR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
15 Jul 2025to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hui Ying Luk, Ph.D. contact

806-834-0827

huiying.luk@ttu.edu

United States1 site, 1 recruiting
  • Texas Tech University

    Lubbock, Texas, 79409

    Hui Ying Luk, Ph.D., 806-834-0827, huiying.luk@ttu.edu

    Recruiting

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About this study

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

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.

Read more

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
Being tested
Hydration-Dehydration-Rehydration Protocol (HDR)
Keywords
rehydration, hypohydration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hydration-Dehydration-Rehydration Protocol (HDR)Behavioural

    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.

Study groups in NCT07084675
Study groupRoleWhat they receive
Hydration-Dehydration-Rehydration (HDR) Protocol ArmExperimentalParticipants in this arm complete the HDR Protocol over 12 days and attend five lab visits.
Receives: Behavioral: Hydration-Dehydration-Rehydration Protocol (HDR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

  5. Hand grip strength (kg)

    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.

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

  6. Isometric leg pull strength (kg)

    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.

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

  7. Total sleep time (hrs)

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

    Measured: through study completion, 18 days

  8. Sleep efficiency (%)

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

    Measured: through study completion, 18 days

  9. Number of awakenings (count)

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

    Measured: through study completion, 18 days

  10. PBMC H2O2 ( µg/mL)

    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.

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

  11. DRP1 (Arbitrary Units)

    Peripheral blood mononuclear cells (PBMCs) will be isolated from whole blood samples collected at four time points during the HDR Protocol. Fission expression (DRP1).

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

  12. MFN (Arbitrary Units)

    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.

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

  13. PINK1 (Arbitrary Units)

    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.

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

  14. Parkin (Arbitrary Units)

    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.

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

  15. Malondialdehyde (nmol/mg)

    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.

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

Secondary outcomes (3)
  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.

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2025
  2. Study start15 Jul 2025
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07084675
Sponsor's protocol ID
IRB2025-288
Acronym
DRIP
Status last verified
Sep 2025
First submitted
3 Jul 2025
Last updated
17 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All raw data generated from this project will be stored on cloud-based servers at Texas Tech University. Cleaned data in an analysis-ready format will be stored in REDCap and periodically uploaded to repositories. Data of sufficient quality from human participants will be uploaded the Aging Research Biobank to allow others to validate replicate research findings. In alignment with the Data Submission Worksheet for the Aging Research Biobank, the following will be submitted to accompany deidentified data derived from human participants: * Full study protocol * Names and descriptions of data sets * Manual of operations * Annotated data collection forms * Data dictionary * Documentation of calculated variables * Summary of deidentification and crosslinking of study ID with new randomized ID * Any changes made to the protocol over time * Frozen datasets used for the primary publication, when applicable

Questions about this trial

What is this clinical trial studying?

A study testing Hydration-Dehydration-Rehydration Protocol (HDR) in people with Aging, run by Texas Tech University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hui Ying Luk, Ph.D. (806-834-0827, huiying.luk@ttu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.

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