Adequate Hydration and Health Outcomes

NCT07179107 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-01-27

No results posted yet for this study

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

Interventions

OTHER

Baseline - week 1

Habitual fluid intake during week 1

OTHER

Low Water Intake - week 2

Low water intake as described by the protocol

OTHER

Moderate Water Intake - week 3

Moderate Water Intake - Week 3

OTHER

Adequate Water Intake - week 4

Adequate Water Intake - week 4

OTHER

Washout - week 5

Washout - week 5

OTHER

Low fluid intake with non caloric sweeteners - Week 6

Low fluid intake with non caloric sweeteners - Week 6

OTHER

Moderate fluid intake with non caloric sweeteners - Week 7

Moderate fluid intake with non caloric sweeteners - Week 7

OTHER

Adequate fluid intake with non caloric sweeteners - Week 8

Adequate fluid intake with non caloric sweeteners - Week 8

Sponsors & Collaborators

  • Arizona State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-29
Primary Completion
2028-07-02
Completion
2028-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07179107 on ClinicalTrials.gov