DehydrationHYDRATENCT07179107
Adequate Hydration and Health Outcomes
A study testing Baseline - week 1, Low Water Intake - week 2 and Moderate Water Intake - week 3 in people with Dehydration and Dehydration (Physiology), run by Arizona State University at 2 sites in United States.
Trial summary
Cardiovascular diseases (CVD) are the leading cause of death in middle- and high-income countries, according to data from the World Health Organization (WHO). Epidemiological studies have associated low water intake and underhydration with diabetes, chronic kidney disease, and an increased risk of CVD. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration, Dehydration (Physiology), Glucose Abnormalities
- What is being tested?
- Baseline - week 1, Low Water Intake - week 2 and Moderate Water Intake - week 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Sep 2025to 31 Dec 2028
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 18.5-24.9 or 30.0-39.9 kg/m2
- HbA1c ≤7%
- Age 20-65 y
- available for 8 consecutive weeks same day and time
Who cannot join
- Diabetes
- HbA1c >7% BMI ≤18.5, BMI of 25 to <30, or ≥ 40 kg/m2
- night shifting work
- losing or gaining weight during the last 2 months (>5 lbs. fluctuation)
- thyroid medication
- bariatric surgery
Show all 27Show fewer
- Habitual strenuous exercise (>120 min/week) Strenuous exercise is defined as activities that take hard physical effort and make you breathe much harder than normal.
- Construction and other workers that spend signifant portion of their work day outdoors
- Commuting by bicycle
- Eating disorders
- Use of aspirin during the duration of the study
- Cancer
- Renal disease (including kidney stones or recurrent urinary track infections
- Hepatic disease
- Cardiac conditions
- Current infection requiring medication
- Chronic, contagious, infectious diseases such as tuberculosis, Hepatitis A, B, C, or HIV
- Medication that could affect appetite or body weight regulation
- GLP1-RA medication
- Anti-depressent SSRI medication
- Testosterone replacement therapy
- Participating in another study at the same time
- Unable to abstain from alcohol during the study
- Unable to limit caffeinated beverage intake to 1 cup per day
- Donated blood during the past two months
- Uneasibly acessable veins
- Does not have smart phone
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
850 PBC
Phoenix, Arizona, 85004
Holly Emmanuel, MA, 602-935-7138, hydrate.study@gmail.com
- Not yet recruiting
850 Phoenix Bioscience Core
Phoenix, Arizona, 85004
Veronica Martinez, MBA, 480-487-7734, veronica.m.martinez@asu.edu
About this study
Cardiovascular diseases (CVD) are the leading cause of death in middle- and high-income countries, according to data from the World Health Organization (WHO). Epidemiological studies have associated low water intake and underhydration with diabetes, chronic kidney disease, and an increased risk of CVD. Similarly, the prevalence of chronic metabolic dysfunction is increasing dramatically worldwide, becoming both a significant public health concern and a global economic burden. Reports from the WHO indicate that the number of people with diabetes worldwide has risen from 108 million in 1980 to 422 million in 2014, representing 8.5% of adults. Therefore, there is an urgent need to identify modifiable risk factors that could help prevent metabolic dysfunction and mitigate the epidemic of type 2 diabetes (T2D). Evidence suggests that the hormone arginine vasopressin (AVP) may play a key role. AVP is the primary hormone responsible for regulating body fluid balance; however, increased AVP secretion, such as under conditions of low water intake, appears to be a risk factor for developing diabetes.
Increasing water intake may represent a simple and cost-effective way to improve glucose regulation and cardiovascular health. However, many individuals do not prefer drinking plain water, and although beverages with high sugar content may promote greater fluid intake, they also contribute additional calories that can negatively impact body weight and overall health. Thus, the central research question of this study is whether improving hydration with non-sugar-sweetened beverages can provide equivalent benefits for hydration and health outcomes in adults.
Read more
Aim 1: To explore the association between habitual fluid intake and fluid preferences (water and non-sugar-sweetened beverages), hydration biomarkers, and health outcomes in normal-weight and obese adults.
Aim 2: To compare the impact of increased total water intake, provided as plain water or non-sugar-sweetened beverages, on hydration, cardiovascular health, and glucose regulation in normal-weight and obese adults.
Read the detailed description
Protocol
Subjects will first come into the lab for a screening visit (approximately 1 hour). In this visit, they will learn more about the study, provide written informed consent (if they choose to participate), fill out a medical history form, have their weight, height, and body composition measured, and have a finger stick blood test to measure glycosylated hemoglobin (HbA1c). Those with A1c values >7% at screening will not be included in the study. We will provide them with information about HbA1c levels that meet the diagnostic criterion for diabetes immediately. Those with A1c values from 6.5 to ≤7% will be provided with information about HbA1c levels that meet the diagnostic criterion for diabetes at the end of the trial. We will suggest they share this information with their doctor. We will answer any questions they may have.
Two groups of 72 volunteers each will be grouped as having normal weight or obesity based on their BMI. The subjects who enroll in the study will undergo an 8-week cross-ver study with two separate arms based on BMI category. Subjects in each BMI category will be evaluated weekly as described below and depicted in Figure 1:
Week 1: Baseline. During this week, the subjects will maintain their habitual fluid intake without any intervention.
Weeks 2-4 \& Weeks 6-8: All subjects will follow 3 weeks of consuming only plain water and a 3-week of non-sugar sweetened beverages, in a random order.
Weeks 2 and 6: The subject will consume very-low fluid intake, of 1.2 and 1.5 L/day for females and males, respectively.
Week 3 \& week 7: Subjects will consume low fluid intake, of 1.6 and 2.0 L/day for females and males, respectively.
Week 4 \& week 8: Subjects will consume adequate fluid intake according to the US dietary guidelines (2.2 and 3.0 L/day L/day for females and males, respectively).
Week 5: Wash-out period, where subjects can return to their habitual fluid and dietary intake.
Fluid intake:
Fluid intake will be controlled by providing drinks and programmable smart water bottles to record fluid intake and provide periodic reminders.
Plain Water:
During the 3 weeks, subjects will be instructed to consume fluids only in the form of plain water (tap, bottle, sparkling), coffee up to 1 cup a day, and alcohol, up to 2 servings per week only during week 5 but not anywhere else during the study.
Non-Sugar-Sweetened beverages:
During the 3-week period, of the NSSB portion of the study 1.0 L of fluids per day will be coming from non-sugar-sweetened beverages, with the rest coming from water.
Procedures:
During this study, beverages will be provided for participants. Programmable smart water bottles will be used to record fluid intake and provide periodic reminders.
Participants will be instructed to keep their diet as usual, without making any changes during the study. The ASA24 will be administered at the end of weeks 1, 2, 3, 4, 5, 6, 7, and 8. The volunteers will be asked to fill out 24-hour recalls (ASA24) three times each one of the weeks 1, 2 and 3. We will collect 2 weekdays and 1 weekend day. ASA24 is an online nutritional assessment tool developed by the NCI.
1 Week before data collection begins: Subjects will visit the lab to place the CGM for baseline data collection, distribute frozen meals, watches, urine containers, and water bottles.
Day Before each Testing:
During the 24 hours prior to each testing day, subjects will be provided with verbal and written instructions on the 24-h urine collection protocol and two 3L urine collection containers, which will include the preservative. They will be asked to collect all their urine beginning with the second void of the day. The first morning urine sample will not be collected; the second void on the day before testing will begin the 24-hour collection. The last urine sample to be collected will be the first morning urine sample of the testing day in a separate container. To measure compliance with the 24-h urine collection protocol, subjects will be asked to complete a 24-h urine collection log. They will record the time when they collect the urine samples, and if they missed any voids. Urine will be analyzed for hydration measures, urine creatinine, and non-nutritive sweeteners. Also participants will have to consume the same dinner before each one of the 8 lab visits, that will be provided in the form of frozen meal from the research team.
TESTING DAYS Each subject will visit the lab once a week for 8 consecutive weeks after at least 10 h of fasting. Upon arrival in the lab, subjects will provide a urine sample measured for hydration biomarkers and their body weight and body composition will be assessed on a bioelectrical impedance scale. We will acess seated blood pressure. Next, participants will fill out cognitive and perceptual questionaires. After this we will access resting metabolic rate, endothelial function by flow mediated dilation (FMD). After the completion of the FMD test, we will proceed to the oral glucose tolerance test (OGTT).
Glycemic Test:
Three separate glycemic tests will be performed depending on the stage of the protocol:
- Insulin Resistance on Matthews's homeostatic model assessment of insulin resistance (HOMA-IR) is based on fasting glucose and insulin.
- Oral Glucose Tolerance Test (OGTT). This 120-minute test consists of a fasted blood sample followed by 75 grams of glucose solution ingestion. Four more blood samples will be collected 30, 60, 90, and 120 minutes after the ingestion.
- Ambulatory 24-hour glucose responses will be assessed via continuous glucose monitor (CGM) during the 7-week intervention. Each CGM lasts for 14 days, thus 4 monitors will be used for each volunteer. The Abbott libre pro will be used to asses interstitial blood glucose every 15 min.
Blood Analysis:
Fasting blood samples will analyzed for :
- Glucose and insulin to assess insulin resistance based on Matthews's homeostatic model assessment of insulin resistance (HOMA-IR).
- Osmolality, sodium, and copeptin for hydration assessment.
- Glucagon and cortisol, since both are stimulated by vasopressin, and impacting glucose regulation.
Blood Samples during the Oral Glucose Tolerance Test (OGTT) will be analyzed:
- Glucose, insulin, glucagon, and cortisol. The primary outcome of the OGTT will be the area under the curve for glucose, insulin, glucagon, and cortisol during the 120-minute test.
Cognitive Data:
A neuropsychological test measuring such aspects of cognition as attention, executive function and memory will be administered to each subject. We will ask participants to complete a cognitive task designed to examine mostly their Executive function (inhibition) abilities, named the Flanker's test. The task will be administered on a laptop computer, lasts 5 minutes and will be given at each visit.
Perceptual Data:
Perceptual data on hunger, cravings, thirst, and mouth dryness will be collected in a pen and paper format.
Mood Assessment:
Mood will be assessed by the validated thirty-five-question Adult Short Profile of Mood States (POMS) questionnaire (POMS 2®-A Short, Multi-Health Systems Inc.). It will be administed on a laptop computer and it lasts 5 min
Sleep Quality Assessment:
This will be assessed via the Pittsburgh Sleep Quality Index. This is a short questionnaire that takes about 2-3 minutes to fill out. The sleep quality assessment will be completed on paper.
Resting Blood pressure:
After the cognitive/ perceptual test, a resting blood pressure in seated position will be taken with and automated blood pressure cuff in duplicate.
Resting Metabolic Rate:
Resting metabolic rate via indirect calorimetry for 30 minutes. This will take place while subjects are resting prior to the flow mediated dilation test.
Flow Mediated Dilation Test:
Endothelium-dependent, FMD of the brachial artery is assessed at baseline (pre-condition) and at the end of each visit (post-condition), at the end of weeks 1, 2, 3, 4, 5, 6, 7, and 8. Measurement procedures are done in accordance with established guidelines and performed by a registered sonographer using B-mode ultrasound (Philips Epic Elite™,Bothell WA). FMD analyses are conducted in a dim, quiet, temperature-controlled environment (22-25 oC) with the participants lying down on an ultrasound bed. Participants will be sized for appropriate blood pressure cuff (Hokanson Instruments, Bellevue, WA) and cuff will be placed around the right arm, 2-3 cm below the elbow/forearm area. Simultaneous ultrasound images (B-mode) and doppler waveforms of the brachial artery are captured for baseline before the blood pressure cuff is inflated to a suprasystolic pressure of 250 mmHg for 5 minutes. After 5 minutes, the cuff will be rapidly deflated, and arterial images will be obtained for 6 minutes post-inflation. Subjects may experience mild discomfort as the cuff is inflated on the upper arm. The images are obtained and analyzed by a trained, blinded researcher using an automated, previously validated FMD software.
Oral Glucose Tolerance Test (OGTT):
Before this test, an indwelling catheter will be placed in an antecubital vein by a trained and experienced phlebotomist using sterile techniques. After a couple of minutes of rest, a baseline blood sample will be taken and the subject will ingest a drink containing 75 g glucose. Four more blocatheterd samples will be taken at 30, 60, 90, and 120 minutes after the drink ingestion. Blood samples will be analyzed for glucose, insulin, glucagon, cortisol, and copeptin. Extra plasma and serum aliquots will be stoford in the deep freezer to -nalysis of other health related biomarkers. The first blood sample will be 15 mL and the remaining four samples will be 10 mL. The total volume for each test will be 55 mL.The total blood volume for all samples during the eight testing sessions will be 440 mL, which is equivalent to a blood donation.
Continuous Glucose Monitor (CGM):
Ambulatory glucose measurements will be obtained using CGM sensors during the entire 8-week period. Since the sensors work for 14 days, a new sensor will be used every two weeks and placed on an alternate arm. The Abbot FreeStyle Libre Pro sensor will be used and it will be applied at the back of the upper arm. A protective round band-aid will also be used to ensure the sensor will not fall off.
Physical Activity:
Physical activity will be assessed via the validated International Physical Activity Questionnaire (IPAQ). This questionnaire will take approximately 2 minutes to complete. Participants will take the questionnaire on paper. The questionnaire will be administered at the end of weeks 1, 2, 3, 4, 5, 6, 7, and 8. IPAQ data will be expressed as a continuous variable of MET-min per week and a three-level categorical variable of physical activity level.
Also, participants will wear a Garmin smart watch that provides heart rate, sleep quality, and time spent on different levels of physical activity. Participants will wear this watch for the entire duration of the intervention. Researchers will provide the watch, and participants will be required to return the watch upon completion of the study.
- Being tested
- Baseline - week 1, Low Water Intake - week 2, Moderate Water Intake - week 3, Adequate Water Intake - week 4, Washout - week 5
- Keywords
- hydration, dehydration, underhydration, fluid intake, non caloric sweeteners
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline - week 1Other
Habitual fluid intake during week 1
Low Water Intake - week 2Other
Low water intake as described by the protocol
Moderate Water Intake - week 3Other
Moderate Water Intake - Week 3
Adequate Water Intake - week 4Other
Adequate Water Intake - week 4
Washout - week 5Other
Washout - week 5
Low fluid intake with non caloric sweeteners - Week 6Other
Low fluid intake with non caloric sweeteners - Week 6
Moderate fluid intake with non caloric sweeteners - Week 7Other
Moderate fluid intake with non caloric sweeteners - Week 7
Adequate fluid intake with non caloric sweeteners - Week 8Other
Adequate fluid intake with non caloric sweeteners - Week 8
| Study group | Role | What they receive |
|---|---|---|
| Baseline - week 1 | Other | Habitual fluid intake during week 1 of the study Receives: Other: Baseline - week 1 |
| Low Water intake - week 2 | Experimental | Low water intake as described by the protocol Receives: Other: Low Water Intake - week 2 |
| Moderate water intake - week 3 | Experimental | Moderate water intake as described by the protocol Receives: Other: Moderate Water Intake - week 3 |
| Adequate Water intake - Week 4 | Experimental | Adequate water intake as described by the protocol Receives: Other: Adequate Water Intake - week 4 |
| Washout period - week 5 | Other | Habitual fluid intake week Receives: Other: Washout - week 5 |
| Low fluid intake with non caloric sweeteners - Week 6 | Experimental | Low fluid intake with non-caloric sweeteners - Week 6 Receives: Other: Low fluid intake with non caloric sweeteners - Week 6 |
| Moderate fluid intake with non caloric sweeteners - Week 7 | Experimental | Moderate fluid intake with non caloric sweeteners - Week 7 Receives: Other: Moderate fluid intake with non caloric sweeteners - Week 7 |
| Adequate fluid intake with non caloric sweeteners - Week 8 | Experimental | Adequate fluid intake with non caloric sweeteners - Week 8 Receives: Other: Adequate fluid intake with non caloric sweeteners - Week 8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilation %
Flow-mediated dilation (FMD) will be assessed as a non-invasive measure of endothelial function using brachial artery ultrasound. A high-resolution ultrasound probe will measure baseline artery diameter, then artery diameter after 5 minutes of forearm cuff occlusion, followed by rapid cuff deflation. FMD% will be calculated as a percent of [(Maximum Post-Deflation Diameter - Baseline Diameter)/Baseline Diameter]×100 This outcome provides the percent increase in brachial artery diameter relative to baseline, reflecting endothelium-dependent vasodilation.
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Area under the curve for glucose
The positive integer of the glucose levels during the 120 minutes post ingestion of 75 g of glucose
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Insulin area under the curve
The positive integer of the insulin levels during the 120 minutes post ingestion of 75 g of glucose
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
glucagon area under the curve
The positive integer of the glucagon levels during the 120 minutes post ingestion of 75 g of glucose
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Cortisol area under the curve
The positive integer of the cortisol levels during the 120 minutes post ingestion of 75 g of glucose
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Mean glucose
Mean weekly interstitial glucose from the continuous glucose monitor
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Glycemic Variability
coefficent of variation (%) of weekly interstitial glucose from the continuous glucose monitor
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Serum copeptin
Serum copeptin/vasopressin at baseline of the oral glucose tolerance test
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Plasma Sodium
Plasma sodium at baseline of the oral glucose tolerance test
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Plasma Osmolality
Plasma osmolality at baseline of the oral glucose tolerance test
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Total Water Intake
Weekly average total water intake from Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Urine volume
24 hours urine volume the day prior to the oral glucose tolerance test
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Urine Osmolality
Urine Osmolality from a 24 hours urine sample the day prior to the oral glucose tolerance test
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Reaction time
Reaction time assessed via Erikson Flankers Test
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Accuracy of cognitive test
Accuracy on the Erikson Flankers cognitive test
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Homeostasis Model Assessment of Insulin Resistance
The Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), as described by Matthews et al., is a validated index used to estimate insulin resistance from fasting plasma glucose and insulin concentrations. It is commonly applied in clinical trials as a practical and reliable surrogate measure of insulin sensitivity when clamp techniques are not feasible.
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention based on the baseline (0 minutes) fasting blood sample.
Secondary outcomes (19)
Confusion-bewilderment
Confusion-bewilderment assessment via the short version of Profile of Mood State Questionnaire. Score range 0-20 with higher score indicating negative mood descriptor
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Depression-dejection
Depression-dejection assessment via the short version of Profile of Mood State Questionnaire. Score range 0-20 with higher score indicating negative mood descriptor
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Fatigue-inertia
Fatigue-inertia assessment via the short version of the Profile of Mood State Questionnaire. Score range 0-20, with higher score indicating a negative mood descriptor
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Vigour-activity
Vigour-activity assessment via the short version of Profile of Mood State Questionnaire. Score range 0-20 with higher score indicating positive mood descriptor
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Total mood disturbance
Total mood disturbance assessment via the short version of the Profile of Mood State Questionnaire. Score range 0-120, with higher score indicating overall negative mood descriptor
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Thirst
Thirst assessed via a visual analog scale
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Hunger
Hunger assessed via a Visual Analog scale
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Total Body Water
Total Body Water assessed via SOZO multiple frequency bioelectrical impedance spectroscopy
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Intracellular Water
Intracellular Water assessed via SOZO multiple frequency bioelectrical impedance spectroscopy
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Extra cellular water
Extra cellular water assessed via SOZO multiple frequency bioelectrical impedance spectroscopy
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Cravings
Cravings assessed via a five questions with a score out of 25
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Urine acesulfame potassium
Urine acesulfame potassium assessed from 24 urine sample the day prior to the oral glucose tolerance test
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Urine Sucralose
Urine sucralose assessed from 24 urine sample the day prior to the oral glucose tolerance test
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Resting Energy Expenditure
Resting Energy expenditure assessed by indirect calorimetry with canopy
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Resting Energy expediture from fat oxidation
Resting Energy expediture from fat oxidation assessed by indirect calorimetry with canopy
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Resting energy expenditure from carbohydrates oxidation
Resting energy expenditure from carbohydrates oxidation assessed by indirect calorimetry with canopy
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Total Caloric Intake
Total Caloric intake from Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Total Sodium intake
Total Sodium intake assessed by the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Total Protein intake
Total Protein Intake from the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Measured: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start29 Sep 2025
- Primary completion2 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized control trial. Data collection will cover a period of 3 years. Each participant will be part of the study for 8 weeks. Each testing day, once a week will last 3.5 hours. First subject in September 2025 and last subject out July 2028
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stavros Kavouras, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179107
- Sponsor's protocol ID
- FP00043890
- Acronym
- HYDRATE
- Status last verified
- Jan 2026
- First submitted
- 4 Sep 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adequate Hydration and Health Outcomes
- ClinicalTrials.gov ID
- NCT07179107
- Acronym / sponsor ID
- HYDRATE / FP00043890
- Keywords
- hydration, dehydration, underhydration, fluid intake, non caloric sweeteners
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 2 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiovascular diseases (CVD) are the leading cause of death in middle- and high-income countries, according to data from the World Health Organization (WHO). Epidemiological studies have associated low water intake and underhydration with diabetes, chronic kidney disease, and an increased risk of CVD. Similarly, the prevalence of chronic metabolic dysfunction is increasing dramatically worldwide, becoming both a significant public health concern and a global economic burden. Reports from the WHO indicate that the number of people with diabetes worldwide has risen from 108 million in 1980 to 422 million in 2014, representing 8.5% of adults. Therefore, there is an urgent need to identify modifiable risk factors that could help prevent metabolic dysfunction and mitigate the epidemic of type 2 diabetes (T2D). Evidence suggests that the hormone arginine vasopressin (AVP) may play a key role. AVP is the primary hormone responsible for regulating body fluid balance; however, increased AVP secretion, such as under conditions of low water intake, appears to be a risk factor for developing diabetes.
Increasing water intake may represent a simple and cost-effective way to improve glucose regulation and cardiovascular health. However, many individuals do not prefer drinking plain water, and although beverages with high sugar content may promote greater fluid intake, they also contribute additional calories that can negatively impact body weight and overall health. Thus, the central research question of this study is whether improving hydration with non-sugar-sweetened beverages can provide equivalent benefits for hydration and health outcomes in adults.
Aim 1: To explore the association between habitual fluid intake and fluid preferences (water and non-sugar-sweetened beverages), hydration biomarkers, and health outcomes in normal-weight and obese adults.
Aim 2: To compare the impact of increased total water intake, provided as plain water or non-sugar-sweetened beverages, on hydration, cardiovascular health, and glucose regulation in normal-weight and obese adults.
Detailed description
Protocol
Subjects will first come into the lab for a screening visit (approximately 1 hour). In this visit, they will learn more about the study, provide written informed consent (if they choose to participate), fill out a medical history form, have their weight, height, and body composition measured, and have a finger stick blood test to measure glycosylated hemoglobin (HbA1c). Those with A1c values >7% at screening will not be included in the study. We will provide them with information about HbA1c levels that meet the diagnostic criterion for diabetes immediately. Those with A1c values from 6.5 to ≤7% will be provided with information about HbA1c levels that meet the diagnostic criterion for diabetes at the end of the trial. We will suggest they share this information with their doctor. We will answer any questions they may have.
Two groups of 72 volunteers each will be grouped as having normal weight or obesity based on their BMI. The subjects who enroll in the study will undergo an 8-week cross-ver study with two separate arms based on BMI category. Subjects in each BMI category will be evaluated weekly as described below and depicted in Figure 1:
Week 1: Baseline. During this week, the subjects will maintain their habitual fluid intake without any intervention.
Weeks 2-4 \& Weeks 6-8: All subjects will follow 3 weeks of consuming only plain water and a 3-week of non-sugar sweetened beverages, in a random order.
Weeks 2 and 6: The subject will consume very-low fluid intake, of 1.2 and 1.5 L/day for females and males, respectively.
Week 3 \& week 7: Subjects will consume low fluid intake, of 1.6 and 2.0 L/day for females and males, respectively.
Week 4 \& week 8: Subjects will consume adequate fluid intake according to the US dietary guidelines (2.2 and 3.0 L/day L/day for females and males, respectively).
Week 5: Wash-out period, where subjects can return to their habitual fluid and dietary intake.
Fluid intake:
Fluid intake will be controlled by providing drinks and programmable smart water bottles to record fluid intake and provide periodic reminders.
Plain Water:
During the 3 weeks, subjects will be instructed to consume fluids only in the form of plain water (tap, bottle, sparkling), coffee up to 1 cup a day, and alcohol, up to 2 servings per week only during week 5 but not anywhere else during the study.
Non-Sugar-Sweetened beverages:
During the 3-week period, of the NSSB portion of the study 1.0 L of fluids per day will be coming from non-sugar-sweetened beverages, with the rest coming from water.
Procedures:
During this study, beverages will be provided for participants. Programmable smart water bottles will be used to record fluid intake and provide periodic reminders.
Participants will be instructed to keep their diet as usual, without making any changes during the study. The ASA24 will be administered at the end of weeks 1, 2, 3, 4, 5, 6, 7, and 8. The volunteers will be asked to fill out 24-hour recalls (ASA24) three times each one of the weeks 1, 2 and 3. We will collect 2 weekdays and 1 weekend day. ASA24 is an online nutritional assessment tool developed by the NCI.
1 Week before data collection begins: Subjects will visit the lab to place the CGM for baseline data collection, distribute frozen meals, watches, urine containers, and water bottles.
Day Before each Testing:
During the 24 hours prior to each testing day, subjects will be provided with verbal and written instructions on the 24-h urine collection protocol and two 3L urine collection containers, which will include the preservative. They will be asked to collect all their urine beginning with the second void of the day. The first morning urine sample will not be collected; the second void on the day before testing will begin the 24-hour collection. The last urine sample to be collected will be the first morning urine sample of the testing day in a separate container. To measure compliance with the 24-h urine collection protocol, subjects will be asked to complete a 24-h urine collection log. They will record the time when they collect the urine samples, and if they missed any voids. Urine will be analyzed for hydration measures, urine creatinine, and non-nutritive sweeteners. Also participants will have to consume the same dinner before each one of the 8 lab visits, that will be provided in the form of frozen meal from the research team.
TESTING DAYS Each subject will visit the lab once a week for 8 consecutive weeks after at least 10 h of fasting. Upon arrival in the lab, subjects will provide a urine sample measured for hydration biomarkers and their body weight and body composition will be assessed on a bioelectrical impedance scale. We will acess seated blood pressure. Next, participants will fill out cognitive and perceptual questionaires. After this we will access resting metabolic rate, endothelial function by flow mediated dilation (FMD). After the completion of the FMD test, we will proceed to the oral glucose tolerance test (OGTT).
Glycemic Test:
Three separate glycemic tests will be performed depending on the stage of the protocol:
- Insulin Resistance on Matthews's homeostatic model assessment of insulin resistance (HOMA-IR) is based on fasting glucose and insulin.
- Oral Glucose Tolerance Test (OGTT). This 120-minute test consists of a fasted blood sample followed by 75 grams of glucose solution ingestion. Four more blood samples will be collected 30, 60, 90, and 120 minutes after the ingestion.
- Ambulatory 24-hour glucose responses will be assessed via continuous glucose monitor (CGM) during the 7-week intervention. Each CGM lasts for 14 days, thus 4 monitors will be used for each volunteer. The Abbott libre pro will be used to asses interstitial blood glucose every 15 min.
Blood Analysis:
Fasting blood samples will analyzed for :
- Glucose and insulin to assess insulin resistance based on Matthews's homeostatic model assessment of insulin resistance (HOMA-IR).
- Osmolality, sodium, and copeptin for hydration assessment.
- Glucagon and cortisol, since both are stimulated by vasopressin, and impacting glucose regulation.
Blood Samples during the Oral Glucose Tolerance Test (OGTT) will be analyzed:
- Glucose, insulin, glucagon, and cortisol. The primary outcome of the OGTT will be the area under the curve for glucose, insulin, glucagon, and cortisol during the 120-minute test.
Cognitive Data:
A neuropsychological test measuring such aspects of cognition as attention, executive function and memory will be administered to each subject. We will ask participants to complete a cognitive task designed to examine mostly their Executive function (inhibition) abilities, named the Flanker's test. The task will be administered on a laptop computer, lasts 5 minutes and will be given at each visit.
Perceptual Data:
Perceptual data on hunger, cravings, thirst, and mouth dryness will be collected in a pen and paper format.
Mood Assessment:
Mood will be assessed by the validated thirty-five-question Adult Short Profile of Mood States (POMS) questionnaire (POMS 2®-A Short, Multi-Health Systems Inc.). It will be administed on a laptop computer and it lasts 5 min
Sleep Quality Assessment:
This will be assessed via the Pittsburgh Sleep Quality Index. This is a short questionnaire that takes about 2-3 minutes to fill out. The sleep quality assessment will be completed on paper.
Resting Blood pressure:
After the cognitive/ perceptual test, a resting blood pressure in seated position will be taken with and automated blood pressure cuff in duplicate.
Resting Metabolic Rate:
Resting metabolic rate via indirect calorimetry for 30 minutes. This will take place while subjects are resting prior to the flow mediated dilation test.
Flow Mediated Dilation Test:
Endothelium-dependent, FMD of the brachial artery is assessed at baseline (pre-condition) and at the end of each visit (post-condition), at the end of weeks 1, 2, 3, 4, 5, 6, 7, and 8. Measurement procedures are done in accordance with established guidelines and performed by a registered sonographer using B-mode ultrasound (Philips Epic Elite™,Bothell WA). FMD analyses are conducted in a dim, quiet, temperature-controlled environment (22-25 oC) with the participants lying down on an ultrasound bed. Participants will be sized for appropriate blood pressure cuff (Hokanson Instruments, Bellevue, WA) and cuff will be placed around the right arm, 2-3 cm below the elbow/forearm area. Simultaneous ultrasound images (B-mode) and doppler waveforms of the brachial artery are captured for baseline before the blood pressure cuff is inflated to a suprasystolic pressure of 250 mmHg for 5 minutes. After 5 minutes, the cuff will be rapidly deflated, and arterial images will be obtained for 6 minutes post-inflation. Subjects may experience mild discomfort as the cuff is inflated on the upper arm. The images are obtained and analyzed by a trained, blinded researcher using an automated, previously validated FMD software.
Oral Glucose Tolerance Test (OGTT):
Before this test, an indwelling catheter will be placed in an antecubital vein by a trained and experienced phlebotomist using sterile techniques. After a couple of minutes of rest, a baseline blood sample will be taken and the subject will ingest a drink containing 75 g glucose. Four more blocatheterd samples will be taken at 30, 60, 90, and 120 minutes after the drink ingestion. Blood samples will be analyzed for glucose, insulin, glucagon, cortisol, and copeptin. Extra plasma and serum aliquots will be stoford in the deep freezer to -nalysis of other health related biomarkers. The first blood sample will be 15 mL and the remaining four samples will be 10 mL. The total volume for each test will be 55 mL.The total blood volume for all samples during the eight testing sessions will be 440 mL, which is equivalent to a blood donation.
Continuous Glucose Monitor (CGM):
Ambulatory glucose measurements will be obtained using CGM sensors during the entire 8-week period. Since the sensors work for 14 days, a new sensor will be used every two weeks and placed on an alternate arm. The Abbot FreeStyle Libre Pro sensor will be used and it will be applied at the back of the upper arm. A protective round band-aid will also be used to ensure the sensor will not fall off.
Physical Activity:
Physical activity will be assessed via the validated International Physical Activity Questionnaire (IPAQ). This questionnaire will take approximately 2 minutes to complete. Participants will take the questionnaire on paper. The questionnaire will be administered at the end of weeks 1, 2, 3, 4, 5, 6, 7, and 8. IPAQ data will be expressed as a continuous variable of MET-min per week and a three-level categorical variable of physical activity level.
Also, participants will wear a Garmin smart watch that provides heart rate, sleep quality, and time spent on different levels of physical activity. Participants will wear this watch for the entire duration of the intervention. Researchers will provide the watch, and participants will be required to return the watch upon completion of the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- This is a randomized control trial. Data collection will cover a period of 3 years. Each participant will be part of the study for 8 weeks. Each testing day, once a week will last 3.5 hours. First subject in September 2025 and last subject out July 2028
| Arm | Type | Receives |
|---|---|---|
| Baseline - week 1 | Other | Other: Baseline - week 1Habitual fluid intake during week 1 of the study |
| Low Water intake - week 2 | Experimental | Other: Low Water Intake - week 2Low water intake as described by the protocol |
| Moderate water intake - week 3 | Experimental | Other: Moderate Water Intake - week 3Moderate water intake as described by the protocol |
| Adequate Water intake - Week 4 | Experimental | Other: Adequate Water Intake - week 4Adequate water intake as described by the protocol |
| Washout period - week 5 | Other | Other: Washout - week 5Habitual fluid intake week |
| Low fluid intake with non caloric sweeteners - Week 6 | Experimental | Other: Low fluid intake with non caloric sweeteners - Week 6Low fluid intake with non-caloric sweeteners - Week 6 |
| Moderate fluid intake with non caloric sweeteners - Week 7 | Experimental | Other: Moderate fluid intake with non caloric sweeteners - Week 7Moderate fluid intake with non caloric sweeteners - Week 7 |
| Adequate fluid intake with non caloric sweeteners - Week 8 | Experimental | Other: Adequate fluid intake with non caloric sweeteners - Week 8Adequate fluid intake with non caloric sweeteners - Week 8 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI 18.5-24.9 or 30.0-39.9 kg/m2
- HbA1c ≤7%
- Age 20-65 y
- available for 8 consecutive weeks same day and time
Key exclusion criteria (27 listed)
- Diabetes
- HbA1c >7% BMI ≤18.5, BMI of 25 to <30, or ≥ 40 kg/m2
- night shifting work
- losing or gaining weight during the last 2 months (>5 lbs. fluctuation)
- thyroid medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline - week 1Habitual fluid intake during week 1 | Other | Baseline - week 1 |
| Low Water Intake - week 2Low water intake as described by the protocol | Other | Low Water intake - week 2 |
| Moderate Water Intake - week 3Moderate Water Intake - Week 3 | Other | Moderate water intake - week 3 |
| Adequate Water Intake - week 4Adequate Water Intake - week 4 | Other | Adequate Water intake - Week 4 |
| Washout - week 5Washout - week 5 | Other | Washout period - week 5 |
| Low fluid intake with non caloric sweeteners - Week 6Low fluid intake with non caloric sweeteners - Week 6 | Other | Low fluid intake with non caloric sweeteners - Week 6 |
| Moderate fluid intake with non caloric sweeteners - Week 7Moderate fluid intake with non caloric sweeteners - Week 7 | Other | Moderate fluid intake with non caloric sweeteners - Week 7 |
| Adequate fluid intake with non caloric sweeteners - Week 8Adequate fluid intake with non caloric sweeteners - Week 8 | Other | Adequate fluid intake with non caloric sweeteners - Week 8 |
Primary outcome
Flow-mediated dilation %
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Flow-mediated dilation (FMD) will be assessed as a non-invasive measure of endothelial function using brachial artery ultrasound. A high-resolution ultrasound probe will measure baseline artery diameter, then artery diameter after 5 minutes of forearm cuff occlusion, followed by rapid cuff deflation. FMD% will be calculated as a percent of [(Maximum Post-Deflation Diameter - Baseline Diameter)/Baseline Diameter]×100 This outcome provides the percent increase in brachial artery diameter relative to baseline, reflecting endothelium-dependent vasodilation.
Area under the curve for glucose
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
The positive integer of the glucose levels during the 120 minutes post ingestion of 75 g of glucose
Insulin area under the curve
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
The positive integer of the insulin levels during the 120 minutes post ingestion of 75 g of glucose
glucagon area under the curve
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
The positive integer of the glucagon levels during the 120 minutes post ingestion of 75 g of glucose
Cortisol area under the curve
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
The positive integer of the cortisol levels during the 120 minutes post ingestion of 75 g of glucose
Mean glucose
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Mean weekly interstitial glucose from the continuous glucose monitor
Glycemic Variability
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
coefficent of variation (%) of weekly interstitial glucose from the continuous glucose monitor
Serum copeptin
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Serum copeptin/vasopressin at baseline of the oral glucose tolerance test
Plasma Sodium
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Plasma sodium at baseline of the oral glucose tolerance test
Plasma Osmolality
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Plasma osmolality at baseline of the oral glucose tolerance test
Total Water Intake
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Weekly average total water intake from Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Urine volume
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
24 hours urine volume the day prior to the oral glucose tolerance test
Urine Osmolality
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Urine Osmolality from a 24 hours urine sample the day prior to the oral glucose tolerance test
Reaction time
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Reaction time assessed via Erikson Flankers Test
Accuracy of cognitive test
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Accuracy on the Erikson Flankers cognitive test
Homeostasis Model Assessment of Insulin Resistance
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention based on the baseline (0 minutes) fasting blood sample.
The Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), as described by Matthews et al., is a validated index used to estimate insulin resistance from fasting plasma glucose and insulin concentrations. It is commonly applied in clinical trials as a practical and reliable surrogate measure of insulin sensitivity when clamp techniques are not feasible.
19 secondary outcomes
Confusion-bewilderment
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Depression-dejection
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Fatigue-inertia
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Vigour-activity
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Total mood disturbance
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Thirst
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Hunger
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Total Body Water
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Intracellular Water
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Extra cellular water
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Cravings
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Urine acesulfame potassium
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Urine Sucralose
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Resting Energy Expenditure
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Resting Energy expediture from fat oxidation
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Resting energy expenditure from carbohydrates oxidation
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Total Caloric Intake
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Total Sodium intake
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Total Protein intake
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline - week 1, Low Water Intake - week 2 and Moderate Water Intake - week 3 in people with Dehydration and Dehydration (Physiology), run by Arizona State University at 2 sites 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 4 inclusion and 27 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 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Holly Emmanuel (602-935-7138, hydrate.study@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow-mediated dilation % (time frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention). The study lists 16 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 27 Jan 2026.