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Children Rehydration During Exercise (ROAR)

Primary Purpose

Dehydration in Children

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rehydration with plain water
Rehydration Drink
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dehydration in Children

Eligibility Criteria

8 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Girls and boys age 8 to 10 years Willing to walk and cycle in a warm environment (80-85°F) Body weight ≤85th percentile for their age group Exclusion Criteria: History of conditions known to alter body water balance (diabetes, renal disease, etc.) Drugs that (may) influence hydration status (including Selective serotonin reuptake inhibitor (SSRI), ADHD medication, diuretics and corticoids) Physical or mental disabilities that would prevent participation in moderate-intensity treadmill walking/jogging and cycling Previous diagnosis of heat stroke Body weight ≥86th percentile for their age group

Sites / Locations

  • Interdisciplinary Science and Technology Building 8Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Water

Low Carb drink

Arm Description

Plain Water

Roaring Water

Outcomes

Primary Outcome Measures

Fluid intake during the 3 hour period
ad-libitum fluid intake
Net Fluid Balance based on body weight changes

Secondary Outcome Measures

Urine output
Cumulative urine volume
urine osmolality
Urine osmotic excretion

Full Information

First Posted
August 23, 2023
Last Updated
October 12, 2023
Sponsor
Arizona State University
Collaborators
Kraft Heinz Company
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1. Study Identification

Unique Protocol Identification Number
NCT06084702
Brief Title
Children Rehydration During Exercise
Acronym
ROAR
Official Title
Kids Rehydration During Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2023 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University
Collaborators
Kraft Heinz Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The low fluid intake in combination with a high intake of sugar-sweetened beverages (SSB) by children is a significant concern among public health professionals. Therefore reformulation of existing commercially available beverages has been suggested as one of the strategies to change SSB beverage behaviors of children. It has been suggested that lack of flavor in plain water is one of the factors of low water intake in children. Therefore, the addition of a flavor to a low-carbohydrate beverage might increase and facilitate the voluntary fluid intake in children, and result in more effective rehydration during and after exercise. The present study aims to examine if a lower sugar flavored water will improve voluntary hydration in children that perform multiple exercise bouts within a period of 3 hours.
Detailed Description
Subject will enter a warm room with a temperature between 28-30°C (80-85°F). Then, subjects will undergo a 3-hour walk, cycle, and rest protocol. The exercise intensity is based on 70% of the subject's predicted heart rate using the formula: 220 beats per minute (bpm) - 10 years of age = 210 bpm, and 70% equals 147 bpm). This is an intensity in which the subject has an elevated breathing frequency but can still talk. During the 3-h period subject will complete the following one-hour test three times: 10 min walking on the treadmill at 70% of predicted max heart rate (~147 bpm) 5 min rest 10 min cycling on the cycle ergometer at 70% of predicted max heart rate (~147 bpm) 35 min rest During the 3-h period, subjects will have free access to fluids Body weight and urine samples will be collected during the experiement

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration in Children

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized Crossover
Masking
Participant
Masking Description
non-identifiable bottles
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Water
Arm Type
Placebo Comparator
Arm Description
Plain Water
Arm Title
Low Carb drink
Arm Type
Experimental
Arm Description
Roaring Water
Intervention Type
Other
Intervention Name(s)
Rehydration with plain water
Intervention Description
Plain water without calories, sweetener, or electolytes
Intervention Type
Other
Intervention Name(s)
Rehydration Drink
Intervention Description
Roaring Water. An electrolyte drink with low Carbohydrate content
Primary Outcome Measure Information:
Title
Fluid intake during the 3 hour period
Description
ad-libitum fluid intake
Time Frame
1, 2, and 3 hours of the protocol
Title
Net Fluid Balance based on body weight changes
Time Frame
1, 2, and 3 hours of the protocol
Secondary Outcome Measure Information:
Title
Urine output
Description
Cumulative urine volume
Time Frame
1, 2 and 3 hour of the protocol
Title
urine osmolality
Time Frame
1, 2, and 3 hour
Title
Urine osmotic excretion
Time Frame
1, 2, and 3 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Girls and boys age 8 to 10 years Willing to walk and cycle in a warm environment (80-85°F) Body weight ≤85th percentile for their age group Exclusion Criteria: History of conditions known to alter body water balance (diabetes, renal disease, etc.) Drugs that (may) influence hydration status (including Selective serotonin reuptake inhibitor (SSRI), ADHD medication, diuretics and corticoids) Physical or mental disabilities that would prevent participation in moderate-intensity treadmill walking/jogging and cycling Previous diagnosis of heat stroke Body weight ≥86th percentile for their age group
Facility Information:
Facility Name
Interdisciplinary Science and Technology Building 8
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stavros Kavouras, PhD
Phone
602-496-2547
Email
Stavros.kavouras@asu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Children Rehydration During Exercise

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