NCT03525470

Brief Summary

The influence of relatively small decreases in hydration status have been little studied. On two occasions subjects will be allowed to lose about 0,5% of their body weight and one occasion 300ml of water will be consumed. Functional MRI will be used to monitor brain functioning when performing a mental arithmetic task. Heart rate variability will be monitored and related to differences in brain functioning when water has and has not been drunk

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

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

Study Start

First participant enrolled

January 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 15, 2018

Completed
Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

2.2 years

First QC Date

April 13, 2018

Last Update Submit

May 14, 2018

Conditions

Keywords

HydrationBrain functioningHeart-rate variability

Outcome Measures

Primary Outcomes (2)

  • BOLD signal

    Participants will be presented with an arithmetic task, modified for use in the scanner, similar to the Paced Auditory Serial Addition Task: a 'stressful' task that measures calculation ability and is known to elicit an autonomic response 35. Pairs of two digit numbers appeared on a screen in red and participants will be required to mentally add or subtract the numbers. After 2 seconds the screens will be removed and a second screen appeared containing a correct and an incorrect answer. Participants will be required to press either a left or right button to indicate which answer was correct ). The speed of presentation is designed to be just at the level that it is possible to perform the task although it required mental effort and was 'stressful'.This allows investigation of areas of the brain associated with working memory but also those associated with emotional arousal.

    One hour in scanner (1300-1400 hours)

  • Heart-rate variability

    Differences in inter-beat intervals derived from RS800 Polar heart rate monitor with a sampling rate of 1000Hz. Profile to be analysed using the Kubios software

    Differences on two testing occasions (0900 and 1300 hours) will be related to BOLD

Secondary Outcomes (3)

  • Ratings of ,mood and perceived effort

    Rated baseline (0830 hours), 30 mins later, 280 minutes later

  • Change in body weight

    Measured at baseline (0830 hours), after 290 minutes (before urinating) and 300 mintues (after urinating)

  • Osmolality

    Baseline (0830 hours) and after 300 minutes

Study Arms (2)

Water

EXPERIMENTAL

Subjects consumed water

Biological: Water

No water

EXPERIMENTAL

Subjects did not consume water

Other: No drink

Interventions

WaterBIOLOGICAL

150 mil of water was drunk on two occasions

Water

Although body weight lost no drink consumed

No water

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Self declared as healthy and not taking any medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Cross-over design where on one occasion subjects lost 0.5% body weight,and drank 300ml water and on another occasion nothing was consumed
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 13, 2018

First Posted

May 15, 2018

Study Start

January 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

May 15, 2018

Record last verified: 2018-05