Recruiting

Hydration & Health

Sponsor:

Arizona State University

Code:

NCT07179107

Conditions

Dehydration

Dehydration (Physiology)

Glucose Abnormalities

Cardiovascular

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Accepted

Interventions

Baseline - week 1

Low Water Intake - week 2

Moderate Water Intake - week 3

Adequate Water Intake - week 4

Washout - week 5

Study Details

Brief 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. 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.

Conditions

Dehydration

Dehydration (Physiology)

Glucose Abnormalities

Cardiovascular

Study ID

NCT07179107

Start date

Sep 29, 2025

Status verified date

Jan, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jul 2, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Baseline - week 1

Habitual fluid intake during week 1 of the study

experimental: Low Water intake - week 2

Low water intake as described by the protocol

experimental: Moderate water intake - week 3

Moderate water intake as described by the protocol

experimental: Adequate Water intake - Week 4

Adequate water intake as described by the protocol

other: Washout period - week 5

Habitual fluid intake week

experimental: Low fluid intake with non caloric sweeteners - Week 6

Low fluid intake with non-caloric sweeteners - Week 6

experimental: Moderate fluid intake with non caloric sweeteners - Week 7

Moderate fluid intake with non caloric sweeteners - Week 7

experimental: Adequate fluid intake with non caloric sweeteners - Week 8

Adequate fluid intake with non caloric sweeteners - Week 8

Interventions

Baseline - week 1

Habitual fluid intake during week 1

Low Water Intake - week 2

Low water intake as described by the protocol

Moderate Water Intake - week 3

Moderate Water Intake - Week 3

Adequate Water Intake - week 4

Adequate Water Intake - week 4

Washout - week 5

Washout - week 5

Low fluid intake with non caloric sweeteners - Week 6

Low fluid intake with non caloric sweeteners - Week 6

Moderate fluid intake with non caloric sweeteners - Week 7

Moderate fluid intake with non caloric sweeteners - Week 7

Adequate fluid intake with non caloric sweeteners - Week 8

Adequate fluid intake with non caloric sweeteners - Week 8

Primary outcome measure

  • Flow-mediated dilation % [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention ]
  • Area under the curve for glucose [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention ]
  • Insulin area under the curve [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention ]
  • glucagon area under the curve [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention ]
  • Cortisol area under the curve [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention ]
  • Mean glucose [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention ]
  • Glycemic Variability [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention ]
  • Serum copeptin [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention ]
  • Plasma Sodium [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention ]
  • Plasma Osmolality [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention ]
  • Total Water Intake [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention ]
  • Urine volume [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention ]
  • Urine Osmolality [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention ]
  • Reaction time [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention ]
  • Accuracy of cognitive test [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention ]
  • 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. ]

Central Contacts and Locations

Central contacts

Holly Emmanuel

602-935-7138hydrate.study@gmail.com

Locations

850 PBC

Recruiting

Phoenix, Arizona, United States, 85004

Contacts

Holly Emmanuel, MA

602-935-7138hydrate.study@gmail.com

More Information

Sponsor

Arizona State University

Last update posted

Jan 27, 2026

Last verified

Jan, 2026

Keywords

  • hydration
  • dehydration
  • underhydration
  • fluid intake
  • non caloric sweeteners

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Arizona State University on 2026-01-27.