- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02671149
The Effect of Small Changes in Hydration on Cognition
How do Small Changes in Hydration Influence Cognition: A Mechanistic Investigation
Study Overview
Detailed Description
As an essential nutrient, an inadequate intake of water has negative consequences: without a source of water death will occur in days. When Benton and Young (2015) reviewed the topic they concluded that in healthy adults, mild dehydration (in the range of a loss of 2% body mass) had been found to adversely influence mood and cognition. However, it is unclear at what degree of hypohydration these effects begin to emerge.
This study was designed to determine whether small changes in hydration, of the level that might occur on a day to day basis, influence cognition and mood. During a dehydration protocol (sitting in a room heated to 30 degrees for four hours) young adult participants receive either drink two 150ml cups of water or nothing. Effects on memory, attention and mood are monitored.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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West Glamorgan
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Swansea, West Glamorgan, United Kingdom, SA2 8PP
- Swansea University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- In good general health i.e. no major health condition such as diabetes
- BMI < 30
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Drink water
Participants will receive two 150ml drinks of water during the dehydration protocol
|
Participants will receive two cups of 150ml plain water
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No Intervention: Drink nothing
Participants will drink nothing during the dehydration protocol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Episodic memory - list of 30 words
Time Frame: change from 0 to 180 minutes after the start of the dehydration protocol
|
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
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Focused attention - Eriksen Flanker Task
Time Frame: change from 0 to 180 minutes after the start of the dehydration protocol
|
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.
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change from 0 to 180 minutes after the start of the dehydration protocol
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thirst (Participants rate their thirst)
Time Frame: change from 0 to 180 minutes after the start of the dehydration protocol
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Participants rate their thirst
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change from 0 to 180 minutes after the start of the dehydration protocol
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount of weight lost due to dehydration protocol
Time Frame: 180 minutes
|
participants will be weighed at the start and end of the dehydration protocol and % weight loss calculated
|
180 minutes
|
Body temperature
Time Frame: 180 minutes
|
Change in body temperature will be monitored throughout
|
180 minutes
|
Urine Osmolality
Time Frame: 180 minutes
|
Urine samples will be collected at the start and end of the procedure so that changes in osmolality can be measured.
|
180 minutes
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HYD01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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