GlycaemiaNCT06825962
The Effect of Hydration on Postprandial Metabolic Responses
A study testing Water intake and Water restriction in people with Glycaemia, run by Loughborough University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycaemia
- What is being tested?
- Water intake and Water restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Loughborough University
Loughborough, Leicestershire, LE113TU
Lewis J James, +44 (0) 1509 226305, L.James@lboro.ac.uk
About this study
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).
- Conditions
- Glycaemia
- Being tested
- Water intake, Water restriction
- Keywords
- Hydration, Dehydration, Hypohydration, Glycemia, Glycaemia, Glucose control
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water intakeOther
Water ingested to fully replace sweat losses during exercise.
Water restrictionOther
Water restriction to induce hypohydration of ~3% body mass through sweat losses during exercise.
| Study group | Role | What they receive |
|---|---|---|
| Euhydrated | Experimental | Light exercise in a hot environment with water ingested to fully replace sweat losses and maintain euhydration. Receives: Other: Water intake |
| Hypohydrated | Experimental | Light exercise in a hot environment with water restricted to induce hypohydration of ~3% body mass through sweating. Receives: Other: Water restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose
Measured using colorimetric assay from venous blood samples
Measured: 6 hours
Secondary outcomes (11)
Plasma insulin
Measured using ELISA from venous blood samples
Measured: 6 hours
Plasma osmolality
Measured using freezing point depression from venous blood samples
Measured: 6 hours
Plasma volume change
Determined from haemoglobin and haematocrit measures in blood samples collected before and after drink ingestion
Measured: 6 hours
Urine volume
Determined from urine samples collected before and after exercise
Measured: 6 hours
Body mass
Determined from weighing participants before and after exercise
Measured: 6 hours
Urine specific gravity/osmolality
Determined from urine samples collected before and after exercise
Measured: 6 hours
Thirst sensation
Measured via 100 mm visual analogue scales 0 mm = not at all thirsty 100 mm = extremely thirsty
Measured: 6 hours
Hunger sensation
Measured via 100 mm visual analogue scales 0 mm = not at all hungry 100 mm = extremely hungry
Measured: 6 hours
Fullness sensation
Measured via 100 mm visual analogue scales 0 mm = not at all full 100 mm = extremely full
Measured: 6 hours
Core body temperature
Measured via ingestible pill
Measured: 6 hours
Blood pressure
Measured via and automated sphygmomanometer
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study startMar 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlycaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised, crossover design
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research Leicester Biomedical Research Centre
- Responsible party
- Principal investigator, Lewis James, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825962
- Sponsor's protocol ID
- 2025-20370
- Other IDs
- 2025
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hydration on Postprandial Metabolic Responses
- ClinicalTrials.gov ID
- NCT06825962
- Acronym / sponsor ID
- 2025-20370
- Conditions
- Glycaemia
- Keywords
- Hydration, Dehydration, Hypohydration, Glycemia, Glycaemia, Glucose control
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- National Institute for Health Research Leicester Biomedical Research Centre
- Study start
- Mar 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised, crossover design
| Arm | Type | Receives |
|---|---|---|
| Euhydrated | Experimental | Other: Water intakeLight exercise in a hot environment with water ingested to fully replace sweat losses and maintain euhydration. |
| Hypohydrated | Experimental | Other: Water restrictionLight exercise in a hot environment with water restricted to induce hypohydration of ~3% body mass through sweating. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water intakeWater ingested to fully replace sweat losses during exercise. | Other | Euhydrated |
| Water restrictionWater restriction to induce hypohydration of ~3% body mass through sweat losses during exercise. | Other | Hypohydrated |
Primary outcome
Plasma glucose
Time frame: 6 hours
Measured using colorimetric assay from venous blood samples
11 secondary outcomes
Plasma insulin
Time frame: 6 hours
Plasma osmolality
Time frame: 6 hours
Plasma volume change
Time frame: 6 hours
Urine volume
Time frame: 6 hours
Body mass
Time frame: 6 hours
Urine specific gravity/osmolality
Time frame: 6 hours
Thirst sensation
Time frame: 6 hours
Hunger sensation
Time frame: 6 hours
Fullness sensation
Time frame: 6 hours
Core body temperature
Time frame: 6 hours
Blood pressure
Time frame: 6 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water intake and Water restriction in people with Glycaemia, run by Loughborough University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lewis J James, PhD (+44 (0) 1509 226305, L.James@lboro.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma glucose (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.