Rehydration Efficiency During Ad-libitum Fluid Intake (LIV-D2O)

It is well established that rehydration with a carbohydrate-electrolyte solution is more effective in comparison to plain water. This is primarily based on the sodium-glucose co transporter, based on which the world health organization has based its oral rehydration solution recommendations. Also, rehydration with a solution that includes sodium and glucose plasma osmolality should not drop as much as it happens during rehydration with water. As a result, we should have higher fluid intake due to higher thirst perception and lower urinary output due to higher levels of vasopressin.

The present study aims to examine the effectiveness of a electrolyte-glucose drink on rehydration following exercise-induced dehydration.

Study Overview

• Status: Not yet recruiting
• Conditions: Dehydration
• Intervention / Treatment: Other: Plain Water; Other: Liquid IV Hydration Multiplier; Other: Liquid IV Sugar Free

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stavros Kavouras, PhD; Phone Number: (602) 496-2547; Email: stavros.kavouras@asu.edu

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Interdisciplinary Science and Technology Building 8

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18-60 years
• Training at least 2 times per week
• stable weight for the last 2 months (fluctuation less than 5 pounds)

Exclusion Criteria:

• Night shifting work
• Thyroid medication
• Bariatric surgery
• Cardiovascular disease
• Renal disease
• Hepatic disease
• Participating in another study at the same time
• Bodyweight over 110 pounds

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Water; Rehydration with low mineral content bottle water	Other: Plain Water; Plain water without calories, sweetener, or electolytes
Experimental: Carbohydrate Electrolyte solution; Drink with 22 grams of carbohydrate, 1020 milligrams of sodium, and 760 milligrams of potassium per liter. Hydration multiplier liquid IV	Other: Liquid IV Hydration Multiplier; Drink with 22 grams of carbohydrate, 1020 milligrams of sodium, and 760 milligrams of potassium per liter. Hydration multiplier liquid IV
Experimental: Low Sugar electrolyte solution; 10 grams of carbohydrate, 1060 milligrams of sodium, and 760 milligrams of potassium per liter. Sugar free Liquid IV	Other: Liquid IV Sugar Free; 10 grams of carbohydrate, 1060 milligrams of sodium, and 760 milligrams of potassium per liter. Sugar free Liquid IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total fluid intake	Total amount of fluid ingested	4 hours of rehydration
Net fluid balance	amount of water retained during the rehydration period	at 4 hours of the rehydration period
Net fluid balance	amount of water retained during the rehydration period	at 3 hours of the rehydration period
Rate of absorption	The rate of Deuterium appearance in the blood during 30 minutes of rehydration	during the first 30 minutes of rehydration
Rate of absorption	The rate of Deuterium appearance in the blood during 60 minutes of rehydration	during the first 60 minutes of rehydration
Rate of absorption	The rate of Deuterium appearance in the blood during 120 minutes of rehydration	during the first 120 minutes of rehydration
Rate of absorption	The rate of Deuterium appearance in the blood during 180 minutes of rehydration	during the first 180 minutes of rehydration
Rate of absorption	The rate of Deuterium appearance in the blood during 240 minutes of rehydration	during the first 240 minutes of rehydration
Cumulative urine output	Total amount of urine output during rehydration	during the first 3 hours of rehydration
Cumulative urine output	Total amount of urine output during rehydration	during the first 4 hours of rehydration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma copeptin	Plasam Copeptin during rehydration	at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period
Plasma volume	percent of plasma volume recovery during the rehydration	at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period
Free water Clearance	Free water clearance calculated based on plasma and urine osmolality	at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period
Free Osmotic Clearance	Free Osmotic clearance calculated based on plasma and urine osmolality	at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period
Thirst	Thirst estimated with a visual analog scale from 0-125 millimeters with higher value indicating greater perception	at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period
Stomach fullness	Stomach fullness estimated with a visual analog scale from 0-125 millimeters with higher value indicating greater perception	at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period
Taste Likeness	Taste Likeness estimated with a visual analog scale from 0-125 millimeters with higher value indicating greater perception	at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period

Collaborators and Investigators

• Sponsor: Arizona State University

Study record dates

Study Major Dates

• Study Start (Estimated): May 21, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 9, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration
• Other Study ID Numbers: FP00039672

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No