The Effect of Hydration on Postprandial Metabolic Responses

February 10, 2025 updated by: Lewis James, Loughborough University

Certain populations, such as industrial workers and endurance athletes are particularly susceptible to dehydration due to exposure to heat for long periods of time causing evaporative water loss via sweating. The physical and cognitive decrements associated with dehydration have been widely researched, however the effect of dehydration on metabolism is lesser known. As climate change is causing temperatures to rise, and metabolic diseases such as type 2 diabetes are more common, the effect of dehydration on metabolism, specifically glycemic response to meals, needs to be established for future recommendations in clinical, environmental and athletic settings.

Therefore, the aim of this study is to investigate the effect of acute exercise-induced dehydration on subsequent metabolic responses to feeding (i.e. glycaemia and insulinaemia).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • Leicestershire
      • Loughborough, Leicestershire, United Kingdom, LE113TU
        • Loughborough University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male or female
  • Generally fit and healthy
  • Participate in endurance or intermittent exercise at least 3 times a week or minimum of 150 minutes moderate intensity activity per week

Exclusion Criteria:

  • < 18 or > 45
  • Any health condition that may affect study outcomes (e.g., endocrine/liver/renal/cardiovascular disease)
  • Any morbidity that affects ability to cycle
  • Smoker or vaper

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Euhydrated
Light exercise in a hot environment with water ingested to fully replace sweat losses and maintain euhydration.
Other: Water intake
Water ingested to fully replace sweat losses during exercise.
Experimental: Hypohydrated
Light exercise in a hot environment with water restricted to induce hypohydration of ~3% body mass through sweating.
Other: Water restriction
Water restriction to induce hypohydration of ~3% body mass through sweat losses during exercise.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plasma glucose
Time Frame: 6 hours
Measured using colorimetric assay from venous blood samples
6 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma insulin
Time Frame: 6 hours
Measured using ELISA from venous blood samples
6 hours
Plasma osmolality
Time Frame: 6 hours
Measured using freezing point depression from venous blood samples
6 hours
Plasma volume change
Time Frame: 6 hours
Determined from haemoglobin and haematocrit measures in blood samples collected before and after drink ingestion
6 hours
Urine volume
Time Frame: 6 hours
Determined from urine samples collected before and after exercise
6 hours
Body mass
Time Frame: 6 hours
Determined from weighing participants before and after exercise
6 hours
Urine specific gravity/osmolality
Time Frame: 6 hours
Determined from urine samples collected before and after exercise
6 hours
Thirst sensation
Time Frame: 6 hours
Measured via 100 mm visual analogue scales 0 mm = not at all thirsty 100 mm = extremely thirsty
6 hours
Hunger sensation
Time Frame: 6 hours
Measured via 100 mm visual analogue scales 0 mm = not at all hungry 100 mm = extremely hungry
6 hours
Fullness sensation
Time Frame: 6 hours
Measured via 100 mm visual analogue scales 0 mm = not at all full 100 mm = extremely full
6 hours
Core body temperature
Time Frame: 6 hours
Measured via ingestible pill
6 hours
Blood pressure
Time Frame: 6 hours
Measured via and automated sphygmomanometer
6 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
N-back task for working memory (cognitive function)
Time Frame: 3 hours
The task will comprise three progressively harder memory loads (1-Back, 2-Back, 3-Back). Each stimulus type will be used in all memory loads. Participants will have to respond using the space bar when they see a stimulus that is presented one, two, or three steps previously, dependent on the load condition. Each phase will comprise 50 trials with ten targets presented centrally on a plain white screen. Each stimulus will be presented for 1000 ms unless the participant responds and in which case the next trial will begin. Commission errors and correct responses will be used as indices of performance. Commission errors occur when participants respond to non-targets.
3 hours
Go/no-go task for response inhibition (cognitive function)
Time Frame: 3 hours
Participants will be instructed to press the space bar when an image of a tree appears onscreen ("go" stimulus) and to inhibit responding when an image of a football is presented (the "no-go" stimulus). The task will comprise 200 trials, of which 10% will be no-go trials. Each trial will last 500 ms and will have a black image on a white background. The sequence of stimuli will be the same for each participant. In order to allow for pre-potent tendencies to develop, 50 go trials will precede the first no-go trial. Increased commission error responses (i.e. responding incorrectly on a no-go trial) will indicate reduced response inhibition. Commission errors and correct responses will be measured as indices of performance.
3 hours
Oculomotor function antisaccade task
Time Frame: 3 hours
Each trial will start with a 1-second instruction screen prompting participants to focus on the target. A central fixation point will be displayed for one second, followed by a brief blank interval and then the appearance of a red distractor. The distractor will appear randomly to the left or right of the fixation point and will remain visible for 2 seconds. Participants will be instructed to maintain fixation at the centre and then make a saccade in the opposite direction as soon as the distractor appears. The task will include 24 trials, with four additional practice trials. The primary variables measured will be reaction time mean and standard deviation, which reflect inhibition latency and variability. Antisaccade errors, or the number of incorrect saccades, will also be calculated.
3 hours
Oculomotor function prosaccade task
Time Frame: 3 hours
Each trial will begin with a 1-second instruction screen, followed by a central fixation point and a brief blank interval. A green target then will appear randomly to the left or right of the fixation point for 2 seconds. Participants will be instructed to fixate at the centre and then make a saccade towards the target. The task will include a total of 14 trials, with four additional practice trials. The variables measured will be reaction time mean and standard deviation, which indicate prosaccade latency and variability.
3 hours
Oculomotor function smooth pursuit task
Time Frame: 3 hours
A smooth pursuit task consists of participants following a stimulus with their eyes as it moves in an elliptical pattern on a screen. The stimulus is in motion for 60 seconds. The primary variable measured will be the variability in x and y coordinates of the left and the right eye.
3 hours

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Loughborough University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute for Health Research Leicester Biomedical Research Centre

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-20370

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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