Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06825962

The Effect of Hydration on Postprandial Metabolic Responses

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).

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

water intake

Other

Water ingested to fully replace sweat losses during exercise.

Water restriction

Other

Water restriction to induce hypohydration of ~3% body mass through sweat losses during exercise.

Primary outcomes

  1. Plasma glucose

    Time frame: 6 hours

    Measured using colorimetric assay from venous blood samples

Secondary outcomes

  1. Plasma insulin

    Time frame: 6 hours

    Measured using ELISA from venous blood samples

  2. Plasma osmolality

    Time frame: 6 hours

    Measured using freezing point depression from venous blood samples

  3. Plasma volume change

    Time frame: 6 hours

    Determined from haemoglobin and haematocrit measures in blood samples collected before and after drink ingestion

  4. Urine volume

    Time frame: 6 hours

    Determined from urine samples collected before and after exercise

  5. Body mass

    Time frame: 6 hours

    Determined from weighing participants before and after exercise

  6. Urine specific gravity/osmolality

    Time frame: 6 hours

    Determined from urine samples collected before and after exercise

  7. Thirst sensation

    Time frame: 6 hours

    Measured via 100 mm visual analogue scales 0 mm = not at all thirsty 100 mm = extremely thirsty

  8. Hunger sensation

    Time frame: 6 hours

    Measured via 100 mm visual analogue scales 0 mm = not at all hungry 100 mm = extremely hungry

  9. Fullness sensation

    Time frame: 6 hours

    Measured via 100 mm visual analogue scales 0 mm = not at all full 100 mm = extremely full

  10. Core body temperature

    Time frame: 6 hours

    Measured via ingestible pill

  11. Blood pressure

    Time frame: 6 hours

    Measured via and automated sphygmomanometer

Other outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lewis J James, PhD

CONTACT

[email protected]

+44 (0) 1509 226305

Sponsors and collaborators

Lead sponsor

Loughborough University

Other

Collaborators

  • National Institute for Health Research Leicester Biomedical Research Centre

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 13, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.