Children Rehydration During Exercise

Dehydration in Children Clinical Trial

— ROAR  

Official title:

Kids Rehydration During Exercise

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06084702
• Other study ID #: FP00036850
• Status: Recruiting
• Phase: N/A
• Start date: October 14, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: January 2024
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: November 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Dehydration
• Dehydration in Children

Intervention

Other:
• Rehydration with plain water
Plain water without calories, sweetener, or electolytes
• Rehydration Drink
Roaring Water. An electrolyte drink with low Carbohydrate content

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	Kraft Heinz Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluid intake during the 3 hour period	ad-libitum fluid intake	1, 2, and 3 hours of the protocol
Primary	Net Fluid Balance based on body weight changes		1, 2, and 3 hours of the protocol
Secondary	Urine output	Cumulative urine volume	1, 2 and 3 hour of the protocol
Secondary	urine osmolality		1, 2, and 3 hour
Secondary	Urine osmotic excretion		1, 2, and 3 hour