RecruitingNot ApplicableNCT07179107

Adequate Hydration and Health Outcomes


Sponsor

Arizona State University

Enrollment

144 participants

Start Date

Sep 29, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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 Criteria27

  • 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

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Interventions

OTHERBaseline - week 1

Habitual fluid intake during week 1

OTHERLow Water Intake - week 2

Low water intake as described by the protocol

OTHERModerate Water Intake - week 3

Moderate Water Intake - Week 3

OTHERAdequate Water Intake - week 4

Adequate Water Intake - week 4

OTHERWashout - week 5

Washout - week 5

OTHERLow fluid intake with non caloric sweeteners - Week 6

Low fluid intake with non caloric sweeteners - Week 6

OTHERModerate fluid intake with non caloric sweeteners - Week 7

Moderate fluid intake with non caloric sweeteners - Week 7

OTHERAdequate fluid intake with non caloric sweeteners - Week 8

Adequate fluid intake with non caloric sweeteners - Week 8


Locations(2)

850 PBC

Phoenix, Arizona, United States

850 Phoenix Bioscience Core

Phoenix, Arizona, United States

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NCT07179107


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