NCT02671149

Brief Summary

The aim of this study is to determine whether drinking plain water when mildly dehydrated benefits cognitive performance and mood. Volunteers undergo a dehydration protocol designed to result in minor dehydration. While some participants receive two 150ml drinks of water others do not. Differences in cognitive functioning are assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 6, 2020

Status Verified

April 1, 2020

Enrollment Period

6 months

First QC Date

September 22, 2015

Last Update Submit

April 3, 2020

Conditions

CognitionHydration

Outcome Measures

Primary Outcomes (2)

  • Episodic memory - list of 30 words

    Participants listen to a list of 30 words presented using a tape recorder. The words are of similar difficulty and matched for the number of syllables and frequency with which they occur in English. The subjects are asked to recall and write down as many words as possible. The difference in the total number of words remembered from baseline (before the intervention) is analysed.

    change from 0 to 180 minutes after the start of the dehydration protocol

  • Focused attention - Eriksen Flanker Task

    The Arrow Flankers test measures the ability to direct attention and ignore peripheral information. Participants are required to indicate whether the middle arrow is pointing to the right or left by pressing the corresponding arrow on the keyboard. Either side of the central arrow are distractors. Both the average reaction times (in milliseconds) and accuracy are recorded. The difference in performance from baseline (before the intervention) is analysed.

    change from 0 to 180 minutes after the start of the dehydration protocol

Secondary Outcomes (1)

  • Thirst (Participants rate their thirst)

    change from 0 to 180 minutes after the start of the dehydration protocol

Other Outcomes (3)

  • Amount of weight lost due to dehydration protocol

    180 minutes

  • Body temperature

    180 minutes

  • Urine Osmolality

    180 minutes

Study Arms (2)

Drink water

EXPERIMENTAL

Participants will receive two 150ml drinks of water during the dehydration protocol

Dietary Supplement: Water

Drink nothing

NO INTERVENTION

Participants will drink nothing during the dehydration protocol

Interventions

WaterDIETARY_SUPPLEMENT

Participants will receive two cups of 150ml plain water

Drink water

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • In good general health i.e. no major health condition such as diabetes
  • BMI \< 30

You may not qualify if:

  • Not on blood pressure medication or blood thinning medication such as aspirin - No learning difficulty such as dyslexia
  • Diabetes
  • Gastro-intestinal disease
  • High BMI
  • Cholesterol and BP
  • Smoker
  • Dyslexic/dyspraxic
  • Depression or history of depression or other psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swansea University

Swansea, West Glamorgan, SA2 8PP, United Kingdom

Location

Related Publications (2)

  • Benton D, Young HA. Do small differences in hydration status affect mood and mental performance? Nutr Rev. 2015 Sep;73 Suppl 2:83-96. doi: 10.1093/nutrit/nuv045.

    PMID: 26290294BACKGROUND

  • Benton D, Jenkins KT, Watkins HT, Young HA. Minor degree of hypohydration adversely influences cognition: a mediator analysis. Am J Clin Nutr. 2016 Sep;104(3):603-12. doi: 10.3945/ajcn.116.132605. Epub 2016 Aug 10.

    PMID: 27510536DERIVED

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 22, 2015

First Posted

February 2, 2016

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 6, 2020

Record last verified: 2020-04

Locations

GB(1)