Actively Recruiting
Adequate Hydration and Health Outcomes in Normal-Weight and Obese Adults Comparing Plain Water and Non-Sugar-Sweetened Beverages Impact on Cardiovascular and Glucose Regulation
Led by Arizona State University · Updated on 2026-01-27
144
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cardiovascular diseases are a leading cause of death worldwide, with increasing concerns about metabolic dysfunction and type 2 diabetes. Research suggests that the hormone arginine vasopressin (AVP), which regulates body fluid balance, may be linked to diabetes risk when water intake is low. This study aims to explore whether increasing water intake with plain water or non-sugar-sweetened beverages can improve hydration, glucose regulation, and cardiovascular health in normal-weight and obese adults. The study involves two groups of adults classified by body mass index (BMI) as normal weight or obese. Participants will follow an 8-week crossover design with periods of habitual fluid intake, low, moderate, and adequate fluid intake using either plain water or non-sugar-sweetened beverages. Fluid intake is controlled by providing drinks and smart water bottles that record intake and send reminders. The study includes a washout period and weekly lab visits for assessments. Participants will attend weekly lab visits after fasting for at least 10 hours. Assessments include hydration biomarkers from urine samples, body composition, blood pressure, cognitive tests, resting metabolic rate, endothelial function via ultrasound, and oral glucose tolerance tests with multiple blood draws. Continuous glucose monitoring will occur throughout the intervention. Mood, sleep quality, diet, and physical activity will also be monitored using questionnaires and wearable devices. The study's main outcomes include measures of vascular function and glucose regulation over the 8 weeks.
CONDITIONS
Brief Title
Adequate Hydration and Health Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) between 18.5 and 24.9 or between 30.0 and 39.9 kg/m2
- HbA1c less than or equal to 7%
- Age between 20 and 65 years
- Available for 8 consecutive weeks for weekly visits at the same day and time
You will not qualify if you...
- Diagnosis of diabetes
- HbA1c greater than 7%
- BMI less than 18.5, between 25 and less than 30, or 40 and above
- Night shift work
- Weight loss or gain over 5 pounds in the last 2 months
- Use of thyroid medication
- History of bariatric surgery
- Habitual strenuous exercise over 120 minutes per week
- Occupations involving significant outdoor work
- Commuting by bicycle
- Eating disorders
- Use of aspirin during the study
- Cancer
- Kidney disease, kidney stones, or recurrent urinary tract infections
- Liver disease
- Heart conditions
- Current infection requiring medication
- Chronic contagious infections such as tuberculosis, hepatitis A, B, C, or HIV
- Medications affecting appetite or body weight regulation
- Use of GLP1-RA or SSRI medications
- Testosterone replacement therapy
- Participation in another study at the same time
- Unable to abstain from alcohol during the study
- Unable to limit caffeine intake to one cup per day
- Blood donation within the past two months
- Difficult vein access
- No smartphone available
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants maintain their habitual fluid intake without any intervention during this week.
1 visit (in-person)
Duration - 8 weeks
Participants undergo an 8-week crossover intervention with controlled fluid intake, alternating between plain water and non-sugar-sweetened beverages. Fluid intake levels vary weekly from very low to adequate. Participants visit the lab weekly for assessments including urine collection, body composition, blood pressure, cognitive and mood questionnaires, resting metabolic rate, endothelial function testing, and oral glucose tolerance testing.
Weekly visits for 8 weeks (in-person)
Duration - 8 weeks concurrent with intervention
Participants wear a continuous glucose monitor and a smartwatch during the entire intervention to monitor glucose levels, physical activity, heart rate, and sleep quality. Dietary recalls and physical activity questionnaires are completed weekly.
Continuous monitoring with devices; weekly questionnaires
Trial Site Locations
Total: 2 locations
1
850 PBC
Phoenix, Arizona, United States, 85004
Actively Recruiting
2
850 Phoenix Bioscience Core
Phoenix, Arizona, United States, 85004
Not Yet Recruiting
Research Team
H
Holly Emmanuel
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
8
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