Overview

This trial is active, not recruiting.

Condition low fluid intake, chronic
Treatment water intake
Phase phase 0
Sponsor University of Illinois at Urbana-Champaign
Collaborator Danone Research
Start date June 2014
End date October 2015
Trial size 30 participants
Trial identifier NCT02816450, 14701

Summary

The aim of this study is to determine the influence of changes in water intake on changes in cognitive function among preadolescent children. Further, the proposed work will determine the relationship between urinary markers of hydration process and cognitive function. We hypothesize that an increase in water intake will result in greater cognitive performance. In addition, improvements in hydration demonstrated by lower urine concentration will be correlated with greater cognitive performance.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Arm
(Experimental)
Increase water intake to 2 liters per day for 4 days
water intake
(Experimental)
Decrease water intake to 1 liter per day for 4 days
water intake

Primary Outcomes

Measure
Flanker Task Accuracy
time frame: 2 Hours on the morning of Day 5

Secondary Outcomes

Measure
Urine Osmolality
time frame: 24 hours during final day of fluid intake modulation (Day 4)

Eligibility Criteria

Male or female participants from 9 years up to 10 years old.

Inclusion Criteria: 1. Parental/guardian consent 2. Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision). Exclusion Criteria: 1. Participants younger than 9 years and older than 10 years at the time of testing age. 2. Prior diagnosis of cognitive or physical disability, including ADHD (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid). 3. Use of anti-psychotic, anti-depressant, anti-anxiety medication, as well as those medications used for ADD/ADHD (use of any anti-psychotic, anti-depressant, anti-anxiety, and ADD/ADHD medications). 4. Participants must have not yet reached, or be in the earliest stages, of puberty, as measured by a modified test of the Tanner Staging System 5. IQ below 85 6. Use of medications that alter urinary excretion and water metabolism 7. Use of internal electronic device, such as a pacemaker

Additional Information

Official title The Effects of Hydration on Brain, Cognition, Memory & Achievement in Childhood
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Illinois at Urbana-Champaign.