Clinical trial NCT06084702: Children Rehydration During Exercise
Official title: Kids Rehydration During Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dehydration in Children
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Kraft Heinz Company
First posted: 2023-10-16
Enrollment: 21
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized Crossover
Primary purpose: OTHER

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

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

Primary outcomes:
measure: Fluid intake during the 3 hour period
timeFrame: 1, 2, and 3 hours of the protocol
measure: Net Fluid Balance based on body weight changes
timeFrame: 1, 2, and 3 hours of the protocol
Secondary outcomes:
measure: Urine output
timeFrame: 1, 2 and 3 hour of the protocol
measure: urine osmolality
timeFrame: 1, 2, and 3 hour
measure: Urine osmotic excretion
timeFrame: 1, 2, and 3 hour
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Interdisciplinary Science and Technology Building 8
state: Arizona
Study officials:
References: