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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06084702
Other study ID # FP00036850
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 14, 2023
Est. completion date April 6, 2024

Study information

Verified date May 2024
Source Arizona State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date April 6, 2024
Est. primary completion date April 6, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 10 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Rehydration with plain water
Plain water without calories, sweetener, or electolytes
Rehydration Drink
Roaring Water. An electrolyte drink with low Carbohydrate content

Locations

Country Name City State
United States Interdisciplinary Science and Technology Building 8 Phoenix Arizona

Sponsors (2)

Lead Sponsor Collaborator
Arizona State University Kraft Heinz Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fluid intake during the 3 hour period ad-libitum fluid intake 1, 2, and 3 hours of the protocol
Primary Net Fluid Balance based on body weight changes 1, 2, and 3 hours of the protocol
Secondary Urine output Cumulative urine volume 1, 2 and 3 hour of the protocol
Secondary urine osmolality 1, 2, and 3 hour
Secondary Urine osmotic excretion 1, 2, and 3 hour
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