Children Rehydration During Exercise

NCT ID: NCT06084702

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-14
• Study Completion Date: 2024-04-06

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

Conditions

Dehydration in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Water

Plain Water

Group Type: PLACEBO_COMPARATOR

Rehydration with plain water

Intervention Type: OTHER

Plain water without calories, sweetener, or electolytes

Low Carb drink

Roaring Water

Group Type: EXPERIMENTAL

Rehydration Drink

Intervention Type: OTHER

Roaring Water. An electrolyte drink with low Carbohydrate content

Interventions

Rehydration with plain water

Plain water without calories, sweetener, or electolytes

Intervention Type: OTHER

Rehydration Drink

Roaring Water. An electrolyte drink with low Carbohydrate content

Intervention Type: OTHER

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kraft Heinz Company

INDUSTRY

Sponsor Role: collaborator

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Interdisciplinary Science and Technology Building 8

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

FP00036850

Identifier Type: -

Identifier Source: org_study_id