Autonomic Adaptations to Hydration and Brain Functioning

May 14, 2018 updated by: David Benton, Swansea University

Autonomic Adaptation to Hydration and Brain Functioning

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

On two mornings twelve male participants will be exposed to a temperature of 30oC for four hours and either drink or not drink two 150ml glasses of water during that time. The subjects the participate in an fMRI protocol during which they complete a modified version of the Paced Auditory Serial Addition Test (PASAT): a challenging arithmetic task designed to elicit autonomic arousal.

Throughout the morning subjects will their heart rate variability (HRV) monitored. At periodic intervals subjects will rate their thirst and mood by visual analogue scales and at the end of the PASAT task they rate its difficulty. Changes in body temperature and fluid loss (perspiration and urine) and urine osmolality will be monitored.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Self declared as healthy and not taking any medication

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Water
Subjects consumed water
Biological: Water
150 mil of water was drunk on two occasions
EXPERIMENTAL: No water
Subjects did not consume water
Other: No drink
Although body weight lost no drink consumed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BOLD signal
Time Frame: One hour in scanner (1300-1400 hours)
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
Time Frame: Differences on two testing occasions (0900 and 1300 hours) will be related to BOLD
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratings of ,mood and perceived effort
Time Frame: Rated baseline (0830 hours), 30 mins later, 280 minutes later
Using visual analogue scales mood and perceived effort will be rated.
Rated baseline (0830 hours), 30 mins later, 280 minutes later
Change in body weight
Time Frame: Measured at baseline (0830 hours), after 290 minutes (before urinating) and 300 mintues (after urinating)
Scales, sensitive to 5 grams, will be used to monitor changes in body weight
Measured at baseline (0830 hours), after 290 minutes (before urinating) and 300 mintues (after urinating)
Osmolality
Time Frame: Baseline (0830 hours) and after 300 minutes
Using an Osmomat 300 freezing point osmometer the osmolality of urine will be measured at the beginning and end of testing sessions
Baseline (0830 hours) and after 300 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swansea University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

April 1, 2018

Study Completion (ACTUAL)

April 1, 2018

Study Registration Dates

First Submitted

April 13, 2018

First Submitted That Met QC Criteria

May 14, 2018

First Posted (ACTUAL)

May 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 15, 2018

Last Update Submitted That Met QC Criteria

May 14, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DB-0123-Hydration

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Hydration

Clinical Trials on Water

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe