Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06063655
Status:
RECRUITING
Last Update Posted:
2023-10-02
First Post:
2023-09-22
Brief Title:
Effects of Two Novel Hydration Beverage Formulas on Rehydration in Adults
Sponsor:
University of Memphis
Organization:
University of Memphis
Study Overview
Official Title:
A Randomized Placebo Controlled Semi-Blind Crossover Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Adults
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The electrolyte test products are composed of powder and provided in individual stick packs with 5 vitamins including Vitamins B3 B5 B6 B12 and Vitamin C The products are gluten- soy- and dairy-free and provide electrolytes at concentrations well below the daily value DV The DV tells us how much a particular nutrient in a serving of a food product contributes to a daily diet based on a standard 2000 calorie diet Despite what the name suggests this product is taken orally not intravenously These packets contain a small percentage of the needed total daily electrolytes but adequate amounts to replace lost electrolytes as a result of physical activity
The products will be consumed following a 90-minute bout of cycling exercise at a moderate intensity of 70-80 max heart rate at 30-32C 86-89F and 50 5 relative humidity This same exercise duration and room temperature has been used in a recent study which also utilized the same body temperature monitoring device as proposed in the present study The purpose of the exercise bout is to simulate what many individuals are exposed to when exercising in the heat and to moderately dehydrate subjects as would be the case during a moderate run or cycling event in exercise-trained individuals
Subjects will report to the lab on three separate occasions to consume one of the 3 drinks hydration multiplier sugar-free hydration matrix or water in random order The drinks will be consumed during the post-exercise period 30 minutes following the completion of exercise
The products will be consumed following a 90-minute bout of cycling exercise at a moderate intensity of 70-80 max heart rate at 30-32C 86-89F and 50 5 relative humidity This same exercise duration and room temperature has been used in a recent study which also utilized the same body temperature monitoring device as proposed in the present study The purpose of the exercise bout is to simulate what many individuals are exposed to when exercising in the heat and to moderately dehydrate subjects as would be the case during a moderate run or cycling event in exercise-trained individuals
Subjects will report to the lab on three separate occasions to consume one of the 3 drinks hydration multiplier sugar-free hydration matrix or water in random order The drinks will be consumed during the post-exercise period 30 minutes following the completion of exercise
Detailed Description:
Maintaining adequate hydration is essential to optimal health as well as athletic performance When individuals exercise in particular in a warm environment they can lose excessive amounts of fluids along with necessary electrolytes eg sodium potassium chloride through sweating With dehydration individuals may feel sluggish and can experience impaired physical performance
The use of electrolytes sodium in particular has been used for decades to aid athlete hydration and has led to the development of various sport drinks eg Gatorade Powerade -which also include small amounts of carbohydrate
This study will evaluate the hydration effects of two electrolyte products dissolved in water Hydration Multiplier and Sugar-Free Hydration Multiplier compared to a placebo water The nutrient composition of the Sugar-Free hydration Multiplier is similar to the Liquid IV Hydration Multiplier product currently on the market but without sugar content
The electrolyte test products are composed of powder and provided in individual stick packs with 5 vitamins including Vitamins B3 B5 B6 B12 and Vitamin C The products are gluten- soy- and dairy-free and provide electrolytes at concentrations well below the daily value DV The DV tells us how much a particular nutrient in a serving of a food product contributes to a daily diet based on a standard 2000 calorie diet Despite what the name suggests this product is taken orally not intravenously These packets contain a small percentage of the needed total daily electrolytes but adequate amounts to replace lost electrolytes as a result of physical activity
The products will be consumed following a 90-minute bout of cycling exercise at a moderate intensity of 70-80 max heart rate at 30-32C 86-89F and 50 5 relative humidity This same exercise duration and room temperature has been used in a recent study which also utilized the same body temperature monitoring device as proposed in the present study The purpose of the exercise bout is to simulate what many individuals are exposed to when exercising in the heat and to moderately dehydrate subjects as would be the case during a moderate run or cycling event in exercise-trained individuals
Subjects will report to the lab on three separate occasions to consume one of the 3 drinks hydration multiplier sugar-free hydration matrix or water in random order The drinks will be consumed during the post-exercise period 30 minutes following the completion of exercise
This study design and outcomes have been similarly used in previous rehydration studies that utilized exercise in heat to induce 2 body weight loss with different test products This study will help further the knowledge on how different formulations of hydration beverages eg different carbohydrate and electrolyte compositions alter rehydration following exercise It is hypothesized that both test products will provide improved rehydration above water alone during the post-exercise period Moreover it is believed that the sugar free product may improve hydration similar to the standard Hydration Multiplier
The use of electrolytes sodium in particular has been used for decades to aid athlete hydration and has led to the development of various sport drinks eg Gatorade Powerade -which also include small amounts of carbohydrate
This study will evaluate the hydration effects of two electrolyte products dissolved in water Hydration Multiplier and Sugar-Free Hydration Multiplier compared to a placebo water The nutrient composition of the Sugar-Free hydration Multiplier is similar to the Liquid IV Hydration Multiplier product currently on the market but without sugar content
The electrolyte test products are composed of powder and provided in individual stick packs with 5 vitamins including Vitamins B3 B5 B6 B12 and Vitamin C The products are gluten- soy- and dairy-free and provide electrolytes at concentrations well below the daily value DV The DV tells us how much a particular nutrient in a serving of a food product contributes to a daily diet based on a standard 2000 calorie diet Despite what the name suggests this product is taken orally not intravenously These packets contain a small percentage of the needed total daily electrolytes but adequate amounts to replace lost electrolytes as a result of physical activity
The products will be consumed following a 90-minute bout of cycling exercise at a moderate intensity of 70-80 max heart rate at 30-32C 86-89F and 50 5 relative humidity This same exercise duration and room temperature has been used in a recent study which also utilized the same body temperature monitoring device as proposed in the present study The purpose of the exercise bout is to simulate what many individuals are exposed to when exercising in the heat and to moderately dehydrate subjects as would be the case during a moderate run or cycling event in exercise-trained individuals
Subjects will report to the lab on three separate occasions to consume one of the 3 drinks hydration multiplier sugar-free hydration matrix or water in random order The drinks will be consumed during the post-exercise period 30 minutes following the completion of exercise
This study design and outcomes have been similarly used in previous rehydration studies that utilized exercise in heat to induce 2 body weight loss with different test products This study will help further the knowledge on how different formulations of hydration beverages eg different carbohydrate and electrolyte compositions alter rehydration following exercise It is hypothesized that both test products will provide improved rehydration above water alone during the post-exercise period Moreover it is believed that the sugar free product may improve hydration similar to the standard Hydration Multiplier
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None