Children Rehydration During Exercise

NCT06084702 | Completed

• 1 other identifier: FP00036850
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Dehydration in Children

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Urine output

  1, 2 and 3 hour of the protocol

• urine osmolality

  1, 2, and 3 hour

• Urine osmotic excretion

  1, 2, and 3 hour

Study Arms (2)

Water

PLACEBO COMPARATOR

Plain Water

Other: Rehydration with plain water

Low Carb drink

EXPERIMENTAL

Roaring Water

Other: Rehydration Drink

Interventions

Rehydration with plain water OTHER

Plain water without calories, sweetener, or electolytes

Water

Rehydration Drink OTHER

Roaring Water. An electrolyte drink with low Carbohydrate content

Low Carb drink

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead
• Kraft Heinz Company: collaborator

Study Sites (1)

Interdisciplinary Science and Technology Building 8

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Interventions

Fluid Therapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: non-identifiable bottles
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Crossover

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: October 16, 2023
• Study Start: October 14, 2023
• Primary Completion: April 6, 2024
• Study Completion: April 6, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)