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OpenTrials
Completed

NCT Number: NCT06084702

Children Rehydration During Exercise

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.

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Key information

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Interdisciplinary Science and Technology Building 8

Phoenix, Arizona, 85004, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rehydration with plain water

Other

Plain water without calories, sweetener, or electolytes

Rehydration Drink

Other

Roaring Water. An electrolyte drink with low Carbohydrate content

Primary outcomes

  1. Fluid intake during the 3 hour period

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

    ad-libitum fluid intake

  2. Net Fluid Balance based on body weight changes

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

Secondary outcomes

  1. Urine output

    Time frame: 1, 2 and 3 hour of the protocol

    Cumulative urine volume

  2. urine osmolality

    Time frame: 1, 2, and 3 hour

  3. Urine osmotic excretion

    Time frame: 1, 2, and 3 hour

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • Kraft Heinz Company

Registry information

Official study title

Kids Rehydration During Exercise

Acronym: ROAR

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 16, 2023
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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