Adequate Hydration and Health Outcomes Study
This study is looking at how different levels of water intake affect your health, specifically focusing on how your blood vessels work and how your body handles sugar. Researchers want to understand if drinking enough water can help with conditions like dehydration, problems with blood sugar (glucose abnormalities), and heart health. You would participate in a structured plan over several weeks, trying different amounts of water intake. The study will measure changes in your blood vessel function and how your body processes glucose and insulin to see the impact of hydration. This study is for adults aged 20 to 65 with certain BMI and HbA1c (a measure of average blood sugar) levels.
- Study design
- This interventional study plans to enroll 144 participants, divided into two groups based on their BMI. It involves an 8-week cross-over design where participants will experience different water intake levels.
- What's involved
- You would have a screening visit, then participate for 8 consecutive weeks, coming to the lab weekly on the same day and time. During this time, you would follow specific water intake instructions.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your blood vessel function, glucose, and insulin levels will be measured weekly throughout the 8-week intervention period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Adequate Hydration and Health Outcomes
At a glance
Conditions
NCT07179107
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
850 PBC
Phoenix, Arizonastudy coordinator listed
Recruiting
850 Phoenix Bioscience Core
Phoenix, Arizonastudy coordinator listed
Not yet recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Flow-mediated dilation %1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Flow-mediated dilation (FMD) will be assessed as a non-invasive measure of endothelial function using brachial artery ultrasound. A high-resolution ultrasound probe will measure baseline artery diameter, then artery diameter after 5 minutes of forearm cuff occlusion, followed by rapid cuff deflation. FMD% will be calculated as a percent of \[(Maximum Post-Deflation Diameter - Baseline Diameter)/Baseline Diameter\]×100 This outcome provides the percent increase in brachial artery diameter relative to baseline, reflecting endothelium-dependent vasodilation.
- Area under the curve for glucose1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
The positive integer of the glucose levels during the 120 minutes post ingestion of 75 g of glucose
- Insulin area under the curve1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
The positive integer of the insulin levels during the 120 minutes post ingestion of 75 g of glucose
- glucagon area under the curve1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
The positive integer of the glucagon levels during the 120 minutes post ingestion of 75 g of glucose
- Cortisol area under the curve1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
The positive integer of the cortisol levels during the 120 minutes post ingestion of 75 g of glucose
- Mean glucose1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Mean weekly interstitial glucose from the continuous glucose monitor
- Glycemic Variability1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
coefficent of variation (%) of weekly interstitial glucose from the continuous glucose monitor
- Serum copeptin1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Serum copeptin/vasopressin at baseline of the oral glucose tolerance test
- Plasma Sodium1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Plasma sodium at baseline of the oral glucose tolerance test
- Plasma Osmolality1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Plasma osmolality at baseline of the oral glucose tolerance test
- Total Water Intake1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Weekly average total water intake from Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
- Urine volume1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
24 hours urine volume the day prior to the oral glucose tolerance test
- Urine Osmolality1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Urine Osmolality from a 24 hours urine sample the day prior to the oral glucose tolerance test
- Reaction time1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Reaction time assessed via Erikson Flankers Test
- Accuracy of cognitive test1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention
Accuracy on the Erikson Flankers cognitive test
- Homeostasis Model Assessment of Insulin Resistance1, 2, 3, 4, 5, 6, 7, 8 weeks of the intervention based on the baseline (0 minutes) fasting blood sample.
The Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), as described by Matthews et al., is a validated index used to estimate insulin resistance from fasting plasma glucose and insulin concentrations. It is commonly applied in clinical trials as a practical and reliable surrogate measure of insulin sensitivity when clamp techniques are not feasible.