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Clinical Trials/NCT06084702
NCT06084702CompletedNot Applicable

Kids Rehydration During Exercise

Arizona State University1 site in 1 country21 target enrollmentStarted: October 14, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
1
Primary Endpoint
Net Fluid Balance based on body weight changes

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Single (Participant)

Masking Description

non-identifiable bottles

Eligibility Criteria

Ages
8 Years to 10 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Low Carb drink

Experimental

Roaring Water

Intervention: Rehydration Drink (Other)

Water

Placebo Comparator

Plain Water

Intervention: Rehydration with plain water (Other)

Outcomes

Primary Outcomes

Net Fluid Balance based on body weight changes

Time Frame: 1, 2, and 3 hours of the protocol

Fluid intake during the 3 hour period

Time Frame: 1, 2, and 3 hours of the protocol

ad-libitum fluid intake

Secondary Outcomes

  • Urine osmotic excretion(1, 2, and 3 hour)
  • urine osmolality(1, 2, and 3 hour)
  • Urine output(1, 2 and 3 hour of the protocol)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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