NCT02816450

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

1.3 years

First QC Date

June 17, 2016

Last Update Submit

July 28, 2018

Conditions

Keywords

WaterChildrenCognitionHydration

Outcome Measures

Primary Outcomes (1)

  • Flanker Task Accuracy

    2 Hours on the morning of Day 5

Secondary Outcomes (1)

  • Urine Osmolality

    24 hours during final day of fluid intake modulation (Day 4)

Study Arms (2)

HIGH

EXPERIMENTAL

Increase water intake to 2.5 liters per day for 4 days

Behavioral: Water Intake

LOW

EXPERIMENTAL

Decrease water intake to 0.5 liter per day for 4 days

Behavioral: Water Intake

Interventions

Water IntakeBEHAVIORAL
HIGHLOW

Eligibility Criteria

Age9 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parental/guardian consent
  • Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).

You may not qualify if:

  • Participants younger than 9 years and older than 10 years at the time of testing age.
  • Prior diagnosis of cognitive or physical disability, including ADHD (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid).
  • 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).
  • 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
  • IQ below 85
  • Use of medications that alter urinary excretion and water metabolism
  • Use of internal electronic device, such as a pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Kinesiology and Community Health

Urbana, Illinois, 61801, United States

Location

Related Publications (1)

  • Khan NA, Westfall DR, Jones AR, Sinn MA, Bottin JH, Perrier ET, Hillman CH. A 4-d Water Intake Intervention Increases Hydration and Cognitive Flexibility among Preadolescent Children. J Nutr. 2019 Dec 1;149(12):2255-2264. doi: 10.1093/jn/nxz206.

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

Drinking

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

EatingNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 17, 2016

First Posted

June 28, 2016

Study Start

June 1, 2014

Primary Completion

October 1, 2015

Study Completion

June 1, 2018

Last Updated

July 31, 2018

Record last verified: 2018-07

Locations