Adequate Hydration and Health Outcomes

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Arizona State University
Study ID
NCT07179107
Status
Recruiting
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Conditions

  • Cardiovascular
  • Dehydration
  • Dehydration (Physiology)
  • Glucose Abnormalities

Eligibility Criteria

Sex
ALL
Age
20 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Baseline - week 1 — OTHER
    Habitual fluid intake during week 1
  • Low Water Intake - week 2 — OTHER
    Low water intake as described by the protocol
  • Moderate Water Intake - week 3 — OTHER
    Moderate Water Intake - Week 3
  • Adequate Water Intake - week 4 — OTHER
    Adequate Water Intake - week 4
  • Washout - week 5 — OTHER
    Washout - week 5
  • Low 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 7 — OTHER
    Moderate fluid intake with non caloric sweeteners - Week 7
  • Adequate fluid intake with non caloric sweeteners - Week 8 — OTHER
    Adequate fluid intake with non caloric sweeteners - Week 8

Study Details

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.

Key Dates

Start date
Sep 29, 2025
Status verified
Jan 2026
Primary completion
Jul 2, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

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

Primary Outcome Measure

Flow-mediated dilation % [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
850 PBCPhoenixArizona85004
Holly Emmanuel, MA
[email protected]
602-935-7138
850 Phoenix Bioscience CorePhoenixArizona85004
Veronica Martinez, MBA
[email protected]
480-487-7734

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