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Kids Rehydration During Exercise

Primary Purpose

Dehydration in Children, Dehydration Following Exertion (Disorder)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lower sugar flavored water
Plain Water
Sponsored by
University of Hartford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dehydration in Children

Eligibility Criteria

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

Inclusion Criteria: Girls and boys age 8 to 10y Willing and able to walk and cycle at a moderate intensity for sequential brief exercise periods (separated by a brief rest period) repeatedly (3x) in a warm environment (80-85°F) Body weight ≤85th percentile for their age group Exclusion Criteria: History of conditions or current use of medications known to alter body water balance (diabetes, renal disease, SSRI's, etc.) Current or recent (past two weeks) illness involving fever, diarrhea, and/or GI discomfort Physical or mental disabilities and injuries 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

  • University of HartfordRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low Sugar Flavored Water

Plain Water

Arm Description

A commercially available low sugar flavored water (2.88kcal/100ml; 0.57(sugar) +0.03 (stevia)=0.60g/100ml; sodium 7.9mg/100ml).

Plain water (bottled, spring).

Outcomes

Primary Outcome Measures

Net fluid balance (according to body weight change) from baseline to 3 hours post exercise
Net fluid balance (according to body weight change) attributable to sweat/body water losses/additions by control of food/beverage intake and urine/fecal output; post 3 hour post exercise body weight (180min) - baseline body weight (0 minutes) = net fluid balance.

Secondary Outcome Measures

Hydration status change (according to urine concentration) from baseline to 3 hours post exercise
Hydration status change according to urine concentration measurement (osmolality, specific gravity, and color); 3 hour post-exercise urine concentration (180min) - baseline urine concentration (0 minutes) = hydration status change.
Total and compartmental body water change (according to bioelectrical impedance spectroscopy) from baseline to 3 hours post-exercise
Total and compartmental body water change (according to bioelectrical impedance spectroscopy); 3 hour post exercise kilohertz (180 minutes) - baseline kilohertz (0 minutes) = total and compartmental body water change.
Hydration-related perceptual variable change (thirst, mouth dryness, taste pleasantness) from baseline to 3 hours post-exercise
Hydration-related perceptual variable change (thirst, mouth dryness, taste pleasantness; via visual analog scale, measured in millimeters, where higher millimeters represents greater perception of that variable); 3 hours post-exercise millimeters (180min) - baseline millimeters (0min) = hydration-related perceptual variable change

Full Information

First Posted
July 11, 2023
Last Updated
August 4, 2023
Sponsor
University of Hartford
Collaborators
Kraft Heinz Company, Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT05989607
Brief Title
Kids Rehydration During Exercise
Official Title
Kids Rehydration During Exercise (ROAR East)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2023 (Anticipated)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

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

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 present study aims to measure the impact of consuming a lower sugar flavored water compared to an equal amount of plain water during exercise on selected rehydration markers in healthy children. Participants will complete two experimental visits designed to examine the differentiating effects of one of two selected beverages (1) lower sugar flavored water beverage and 2) plain water) on certain hydration markers and related perceptual variables during repeated bouts of exercise in a warm environment to induce mild dehydration.
Detailed Description
Parents of adolescent children have demonstrated a preference to remove added and larger boluses of sugar from their child's diet in accordance with accumulating health concerns. While forms of sugar are often included in oral rehydration solutions, evidence demonstrates that electrolytes such as sodium are the predominant beverage ingredients contributing to rehydration. Determining the efficacy and preference when thirsty of a flavored water beverage (with lower sugar content), compared to plain water could guide future beverage selection to achieve rehydration in young people. Protocol: This is a randomized, counter-balanced, cross-over design study. Thirty participants will be voluntarily enrolled (defined as the completion of assent and successful screening). Upon enrollment, participants will be familiarized to the study procedures: exercise, dietary consumption, urine sample collection, body weight measurement, bioelectrical impedance spectroscopy (BIS) analysis, and perceptual questionnaire completion. Participants will be scheduled to complete two experimental visits within three weeks of one another. Each experimental visit is designed to examine the differentiating effects of one of two selected beverages (1) lower sugar flavored water beverage and 2) plain water) on certain hydration markers and related perceptual variables during repeated bouts of exercise. Day Before study: Participants will consume a standardized frozen dinner (provided by the researchers) and consume at least 250 ml (8oz) of water after dinner. Food and beverages other than water will be prohibited following dinner. Study Day: Participants will arrive at each study visit fasted (no food or beverages within the previous eight hours, except 250 ml of plain water two to three hours prior to the experimental visit). In the event that the participant did not fast, their visit will be rescheduled. Only one visit reschedule will be offered throughout the course of their participation. Upon arrival, participants will then consume a standardized breakfast. Following breakfast (approximately 15min following completion) they will provide a urine sample, the investigators will record body weight and measure body fluids by BIS (in a prone position), and they will complete questionnaires (with appropriate guidance and in visual analogue scale format) about mouth dryness, taste pleasantness, stomach fullness, and thirst. All body weight measurements will be taken with as minimal clothing as possible; only the participant's parent/guardian will be with the participant for this measurement to protect privacy. Each participant will wear the same amount of clothing for every body weight measurement during their individual participation. Subsequently, the participant will enter a warm room with a controlled/recorded temperature between 28-30°C (80-85°F). Then the participant will undergo a 3 hour intermittent walk, cycle, rest protocol. During the 3-h period, each participant will complete the following one hour test, three sequential times: 10 min walking on the treadmill at 70% of age-predicted max heart rate (~140 bpm) 5 min rest 10 min cycling on the cycle ergometer at 70 of age-predicted max heart rate (~140 bpm) 35 min rest During the 3-h period, participants will be provided with the fluid volume equating to 2% of body mass losses (as determined by ongoing individual body weight difference measurements) during each one hour test (water or a lower sugar flavored water beverage); anticipated as ~200ml). During this time body weight, and urine samples, BIS, and perceptual data via questionnaires will be collected (prior to and following each exercise bout).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration in Children, Dehydration Following Exertion (Disorder)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
randomized, counter-balanced, cross-over design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Sugar Flavored Water
Arm Type
Experimental
Arm Description
A commercially available low sugar flavored water (2.88kcal/100ml; 0.57(sugar) +0.03 (stevia)=0.60g/100ml; sodium 7.9mg/100ml).
Arm Title
Plain Water
Arm Type
Active Comparator
Arm Description
Plain water (bottled, spring).
Intervention Type
Other
Intervention Name(s)
Lower sugar flavored water
Intervention Description
A commercially available low sugar flavored water (2.88kcal/100ml; 0.57(sugar) +0.03 (stevia)=0.60g/100ml; sodium 7.9mg/100ml).
Intervention Type
Other
Intervention Name(s)
Plain Water
Intervention Description
Commercially available bottled, spring water.
Primary Outcome Measure Information:
Title
Net fluid balance (according to body weight change) from baseline to 3 hours post exercise
Description
Net fluid balance (according to body weight change) attributable to sweat/body water losses/additions by control of food/beverage intake and urine/fecal output; post 3 hour post exercise body weight (180min) - baseline body weight (0 minutes) = net fluid balance.
Time Frame
baseline to 3 hours post exercise
Secondary Outcome Measure Information:
Title
Hydration status change (according to urine concentration) from baseline to 3 hours post exercise
Description
Hydration status change according to urine concentration measurement (osmolality, specific gravity, and color); 3 hour post-exercise urine concentration (180min) - baseline urine concentration (0 minutes) = hydration status change.
Time Frame
baseline to 3 hours post exercise
Title
Total and compartmental body water change (according to bioelectrical impedance spectroscopy) from baseline to 3 hours post-exercise
Description
Total and compartmental body water change (according to bioelectrical impedance spectroscopy); 3 hour post exercise kilohertz (180 minutes) - baseline kilohertz (0 minutes) = total and compartmental body water change.
Time Frame
baseline to 3 hours post exercise
Title
Hydration-related perceptual variable change (thirst, mouth dryness, taste pleasantness) from baseline to 3 hours post-exercise
Description
Hydration-related perceptual variable change (thirst, mouth dryness, taste pleasantness; via visual analog scale, measured in millimeters, where higher millimeters represents greater perception of that variable); 3 hours post-exercise millimeters (180min) - baseline millimeters (0min) = hydration-related perceptual variable change
Time Frame
baseline to 3 hours post exercise

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 10y Willing and able to walk and cycle at a moderate intensity for sequential brief exercise periods (separated by a brief rest period) repeatedly (3x) in a warm environment (80-85°F) Body weight ≤85th percentile for their age group Exclusion Criteria: History of conditions or current use of medications known to alter body water balance (diabetes, renal disease, SSRI's, etc.) Current or recent (past two weeks) illness involving fever, diarrhea, and/or GI discomfort Physical or mental disabilities and injuries 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colleen Munoz, PhD
Phone
860-768-4368
Email
cmunoz@hartford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Chris Standish, x
Phone
860-768-5938
Email
standish@hartford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen Munoz, PhD
Organizational Affiliation
University of Hartford
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hartford
City
West Hartford
State/Province
Connecticut
ZIP/Postal Code
06117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen Munoz, PhD
Phone
860-768-4368
Email
cmunoz@hartford.edu
First Name & Middle Initial & Last Name & Degree
Chris Standish
Phone
860-768-5938
Email
standish@hartford.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Kids Rehydration During Exercise

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