NCT05989607

Brief Summary

The present study aims to measure the impact of consuming a lower sugar flavored water compared to an equal amount of plain water during exercise on selected rehydration markers in healthy children. Participants will complete two experimental visits designed to examine the differentiating effects of one of two selected beverages (1) lower sugar flavored water beverage and 2) plain water) on certain hydration markers and related perceptual variables during repeated bouts of exercise in a warm environment to induce mild dehydration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 10, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2023

Completed
Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

July 11, 2023

Last Update Submit

April 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Net fluid balance (according to body weight change) from baseline to 3 hours post exercise

    Net fluid balance (according to body weight change) attributable to sweat/body water losses/additions by control of food/beverage intake and urine/fecal output; post 3 hour post exercise body weight (180min) - baseline body weight (0 minutes) = net fluid balance.

    baseline to 3 hours post exercise

Secondary Outcomes (3)

  • Hydration status change (according to urine concentration) from baseline to 3 hours post exercise

    baseline to 3 hours post exercise

  • Total and compartmental body water change (according to bioelectrical impedance spectroscopy) from baseline to 3 hours post-exercise

    baseline to 3 hours post exercise

  • Hydration-related perceptual variable change (thirst, mouth dryness, taste pleasantness) from baseline to 3 hours post-exercise

    baseline to 3 hours post exercise

Study Arms (2)

Low Sugar Flavored Water

EXPERIMENTAL

A commercially available low sugar flavored water (2.88kcal/100ml; 0.57(sugar) +0.03 (stevia)=0.60g/100ml; sodium 7.9mg/100ml).

Other: Lower sugar flavored water

Plain Water

ACTIVE COMPARATOR

Plain water (bottled, spring).

Other: Plain Water

Interventions

A commercially available low sugar flavored water (2.88kcal/100ml; 0.57(sugar) +0.03 (stevia)=0.60g/100ml; sodium 7.9mg/100ml).

Low Sugar Flavored Water

Commercially available bottled, spring water.

Plain Water

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Girls and boys age 8 to 10y
  • Willing and able to walk and cycle at a moderate intensity for sequential brief exercise periods (separated by a brief rest period) repeatedly (3x) in a warm environment (80-85°F)
  • Body weight ≤85th percentile for their age group

You may not qualify if:

  • History of conditions or current use of medications known to alter body water balance (diabetes, renal disease, SSRI's, etc.)
  • Current or recent (past two weeks) illness involving fever, diarrhea, and/or GI discomfort
  • Physical or mental disabilities and injuries 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hartford

West Hartford, Connecticut, 06117, United States

Location

Study Officials

  • Colleen Munoz, PhD

    University of Hartford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: randomized, counter-balanced, cross-over design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Associate Professor, Hydration Health Center Director

Study Record Dates

First Submitted

July 11, 2023

First Posted

August 14, 2023

Study Start

August 10, 2023

Primary Completion

October 31, 2023

Study Completion

December 13, 2023

Last Updated

April 11, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations