Children Rehydration During Exercise (ROAR)

Kids Rehydration During Exercise

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.

Study Overview

• Status: Completed
• Conditions: Dehydration in Children
• Intervention / Treatment: Other: Rehydration with plain water; Other: Rehydration Drink

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

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Water; Plain Water	Other: Rehydration with plain water; Plain water without calories, sweetener, or electolytes
Experimental: Low Carb drink; Roaring Water	Other: Rehydration Drink; Roaring Water. An electrolyte drink with low Carbohydrate content

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluid intake during the 3 hour period	ad-libitum fluid intake	1, 2, and 3 hours of the protocol
Net Fluid Balance based on body weight changes		1, 2, and 3 hours of the protocol

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine output	Cumulative urine volume	1, 2 and 3 hour of the protocol
urine osmolality		1, 2, and 3 hour
Urine osmotic excretion		1, 2, and 3 hour

Collaborators and Investigators

• Sponsor: Arizona State University
• Collaborators: Kraft Heinz Company

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2023
• Primary Completion (Actual): April 6, 2024
• Study Completion (Actual): April 6, 2024

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 16, 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: FP00036850

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