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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06414291
Other study ID # FP00039672
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 21, 2024
Est. completion date May 31, 2025

Study information

Verified date May 2024
Source Arizona State University
Contact Stavros Kavouras, PhD
Phone (602) 496-2547
Email stavros.kavouras@asu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date May 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Plain Water
Plain water without calories, sweetener, or electolytes
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
Liquid IV Sugar Free
10 grams of carbohydrate, 1060 milligrams of sodium, and 760 milligrams of potassium per liter. Sugar free Liquid IV

Locations

Country Name City State
United States Interdisciplinary Science and Technology Building 8 Phoenix Arizona

Sponsors (1)

Lead Sponsor Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total fluid intake Total amount of fluid ingested 4 hours of rehydration
Primary Net fluid balance amount of water retained during the rehydration period at 4 hours of the rehydration period
Primary Net fluid balance amount of water retained during the rehydration period at 3 hours of the rehydration period
Primary Rate of absorption The rate of Deuterium appearance in the blood during 30 minutes of rehydration during the first 30 minutes of rehydration
Primary Rate of absorption The rate of Deuterium appearance in the blood during 60 minutes of rehydration during the first 60 minutes of rehydration
Primary Rate of absorption The rate of Deuterium appearance in the blood during 120 minutes of rehydration during the first 120 minutes of rehydration
Primary Rate of absorption The rate of Deuterium appearance in the blood during 180 minutes of rehydration during the first 180 minutes of rehydration
Primary Rate of absorption The rate of Deuterium appearance in the blood during 240 minutes of rehydration during the first 240 minutes of rehydration
Primary Cumulative urine output Total amount of urine output during rehydration during the first 3 hours of rehydration
Primary Cumulative urine output Total amount of urine output during rehydration during the first 4 hours of rehydration
Secondary Plasma copeptin Plasam Copeptin during rehydration at 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours of the rehydration period
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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