Hydration StatusNCT07789847
The Influence of Fluid Intake on Mental Performance
A study testing Modifying daily total fluid intake in people with Hydration Status and Psychosocial Stress, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
Over half of the adult population in Europe, Asia and Latin America fail to meet adequate water intake guidelines as advised by the European Food Safety Authority (EFSA; 2.5 and 2 litres/day for men and women, respectively coming from both food and drinks). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydration Status, Psychosocial Stress, Fluid Intake
- What is being tested?
- Modifying daily total fluid intake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jun 2026to 1 Dec 2027
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals who…
- …are free-living, who fully understand and agree to the objectives of the study, who gave, signed and dated informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
- …are 'healthy' men and current combined oral contraceptive (COC)-using women (having taken the COC for at least 3 months and should they be eligible and willing to participate, are happy to continue taking the same COC during the duration of their participation).
- …are aged 18-35 years
- …engage in < 5 hours of vigorous exercise a week. This information will be obtained during the initial study brief and using the health screening questionnaire.
- …have a habitual fluid consumption of ≤ 1.6 L/day OR ≥ 2.9 L/day for men and ≤ 1.5 L/day OR ≥ 2.5 L/day for women, verified by a 7-day fluid intake record.
Show all 14Show fewer
- …have a day-to-day variation in fluid intake of ≤ 25%.
- …have a verified UOsm aligned with the following:
- IF habitual low TFI, i.e., TFI ≤ 1.5 L/day for women OR ≤ 1.6 L/day for men have a UOsm ≥ 500 mOsm/kg.
- IF habitual high TFI, i.e., TFI ≥ 2.5 L/day for women OR ≥ 2.9 L/day for men have a UOsm < 500 mOsm/kg.
- …have a day-to-day variation in UOsm ≤ 28%; UOsm screening will be determined during verification and intervention periods.
- …have access to a domestic fridge at home so that urine samples can be stored prior to laboratory visits.
- …have a body mass index (BMI) < 30 kg/m².
- …have an IOS or Android smart phone and therefore the ability to download the HidrateSpark mobile application.
Who cannot join
- Individuals who…
- …are vulnerable, as defined by individuals whose willingness to volunteer in the study may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate (for example, if members of a group with a hierarchical structure linked to the investigator or to the sponsor, subordinate laboratory personnel, and employees of the investigator or sponsor.
- …are not able to answer questionnaires by writing whatever the reason.
- …have a loss of personal liberty, by administrative or judicial decision.
- …engage in > 5 hours of vigorous exercise a week.
- …engage in endurance exercise bouts lasting longer than 40 minutes.
Show all 39Show fewer
- …do not have access to a domestic fridge at home so that urine samples can be stored prior to laboratory visits.
- …do not have an IOS or Android smart phone and therefore do not have the ability to download the HidrateSpark application.
- …are currently participating in another relevant clinical study (e.g., likely to influence hydration status or stress responsivity).
- …have completed the TSST before.
- …are expected to be living in the same home as a current participant.
- Health screening
- Individuals who…
- …have had any surgery or medical procedure requiring a general anaesthesia in the preceding 4 weeks, or who plan to have one during the study.
- …have an ongoing clinically diagnosed medical condition.
- …are currently taking prescribed medication for an ongoing medical condition.
- …are clinically diagnosed with one of the following psychiatric disorders known to influence stress reactivity: melancholic or atypical depression; panic disorder; obsessive-compulsive disorder; schizophrenia; social or generalised anxiety disorder; autism spectrum disorder; post-traumatic stress disorder; psychosis.
- …have a clinically diagnosed sleeping disorder.
- …are a current smoker (including e-cigarettes and vapes).
- …have had a respiratory or gastrointestinal infection within the last 2 weeks.
- …have a clinically diagnosed eating disorder.
- …have a special medicated diet (e.g., for obesity, anorexia, metabolic pathology).
- …have changed their dietary habits within the last 4 weeks or plan to change their diet during the study (e.g., start of a high-fibre diet, intentionally reducing or increasing calorie intake).
- …take dietary supplements known to influence stress reactivity (e.g., high-dose caffeine).
- …are women not currently on COC (e.g., naturally menstruating, or on progestogen-only forms of contraception, such as IUS, mini-pill, implant or injection).
- …are women currently using COC but for < 3 months prior to reading the participant information sheet or not planning to continue taking COC during their potential participation in the study.
- …are pregnant women or women planning to become pregnant during the study or are breast-feeding women.
- Total fluid intake screening
- Individuals who…
- …have a daily total fluid intake of:
- Men: between 1.6 and 2.9 L/day.
- Women: between 1.5 and 2.5 L/day.
- …have a day-to-day variation in fluid intake of >25%.
- …have a UOsm of:
- Men: < 500 mOsm/kg if habitual TFI is ≤ 1.6 L.day or ≥ 500 mOsm/kg if habitual TFI is ≥ 2.9 L/day.
- Women: < 500 mOsm/kg if habitual TFI is ≤ 1.5 L/day or ≥ 500 mOsm/kg if habitual TFI is ≥ 2.5 L/day.
- …have a day-to-day variation in UOsm > 28%.
- …habitually consume > 1.3 L/day of caffeinated hot beverages (e.g., tea, coffee; 1.3 L equates to 4 average sized mugs) as estimated by a fluid intake record questionnaire.
- …consume ≥ 91 units of alcohol per month (equivalent to more than 3 pints of beer per day or more than 3 large glasses of red wine per day).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Harry K W Bell, MSc contact
United Kingdom1 site, 1 recruiting
- Recruiting
Liverpool John Moores University
Liverpool
William J Searle, PhD, 01519041031, w.j.searle@ljmu.ac.uk
Harry K Bell, MSc, h.k.bell@ljmu.ac.uk
About this study
Official title: Does Altering Daily Fluid Intake and Hydration Status Influence Cortisol Reactivity to Acute Psychosocial Stress?
Over half of the adult population in Europe, Asia and Latin America fail to meet adequate water intake guidelines as advised by the European Food Safety Authority (EFSA; 2.5 and 2 litres/day for men and women, respectively coming from both food and drinks). Increasing epidemiological evidence suggests that chronic low fluid intake may be associated with an increased risk of cardiovascular, metabolic, and renal diseases. The association between chronic low fluid intake and increased morbidity risk may be underpinned by elevations in key water-regulating hormones, such as arginine vasopressin (AVP) and its surrogate copeptin, which influence glucose regulation and renal function. For example, AVP stimulates the hypothalamic-pituitary adrenal (HPA) axis to release the stress hormone cortisol with potentially far-reaching effects on metabolism, immunity and inflammation. Prospective cohort studies have demonstrated that exaggerated cortisol responses to acute stress are associated with poor health outcomes.
A recent cross-sectional study (NCT05491122) from our group found that individuals with a low habitual fluid intake experienced greater cortisol reactivity to acute stress than those with a high habitual intake. The findings of this study may provide a potential explanation for why poor hydration and low fluid intake have negative effects on long-term health. We now aim to explore whether altering fluid intake influences cortisol reactivity to acute stress.
- Conditions
- Hydration Status, Psychosocial Stress, Fluid Intake
- Being tested
- Modifying daily total fluid intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modifying daily total fluid intakeBehavioural
7-day intervention where the intake of drinking water will either be maintained at habitual level, increased (if habitually low) or decreased (if habitually high). The TFI prescriptions during the intervention are derived from the mean TFI of habitually low and habitually high drinkers from a sex, age and country matched population. Specifically, habitually low drinkers will be permitted a TFI of 3.5 L/day for men and 3.3 L/day for women and habitually high drinkers will be permitted a TFI of 1.3 L/day. Participants will be instructed to maintain their usual intake of other beverages i.e., tea/coffee to achieve their target TFI.
| Study group | Role | What they receive |
|---|---|---|
| Verification period | No intervention | 7 consecutive days where participants will drink fluids as they do normally do. |
| Intervention period | Experimental | 7 consecutive days where the participants will be randomly assigned to either the habitual or intervention condition.
* Habitual: maintain their usual daily total fluid intake.
* Intervention: habitual low daily TFI will be prescribed a total fluid intake of 3.5 L/day for men and 3.3 L/day for women. Habitual high daily total fluid intake will be prescribed a total fluid intake of 1.3 L/day for both men and women.
On day 8, participants will perform a psychosocial stress test.
Participants will be instructed to maintain their usual intake of other beverages i.e., tea/coffee to achieve their target total fluid intake. Receives: Behavioral: Modifying daily total fluid intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary cortisol reactivity to acute psychosocial stress
Changes in the concentration of salivary free cortisol throughout the psychosocial stress test. Cortisol will be measured in stimulated saliva samples and analysed by ELISA. Delta changes (increase/decrease) in cortisol response will also be calculated.
Measured: Assessed during the main trial (day 8 of the intervention period). Saliva samples will be taken pre (-30 and -5 minutes) and post (+0, +10, +20, +30, +45 and +60 minutes) stress test.
Secondary outcomes (6)
Plasma copeptin
Plasma copeptin will be analysed by ELISA and compared cross-sectionally between intervention conditions.
Measured: Copeptin will be assessed using a single blood sample taken on the morning of the main trial (day 8 of intervention period).
Urine osmolality (UOsm)
The concentration of osmotic solutes present in the urine, measured using a freezing point depression osmometer.
Measured: Late-afternoon urine samples will be collected on days 6 and 7 of the verification and intervention periods. Spot urine samples will be collected on the morning and afternoon visits of the main trial (day 8 of the intervention period).
Urine colour
Urine colour, a common marker used for assessing hydration status, will be assessed using a urine colour chart that has been developed to assess urine concentration in healthy humans.
Measured: Late-afternoon urine samples will be collected on days 6 and 7 of the verification and intervention periods. Spot urine samples will be collected on the morning and afternoon visits of the main trial (day 8 of the intervention period).
Plasma osmolality
A marker of intracellular osmolality, measured using a freezing point depression osmometer. Plasma will be derived from venous blood.
Measured: A venous blood sample will be taken on the morning of the main trial (day 8 of the intervention period).
Sleep duration
Total sleep time (minutes) will be measured using accelerometery-based movement data recorded using a wrist-worn actigraph.
Measured: Verification period: an actigraph will be worn continuously from day 5 until the end of the verification period. Intervention period: an actigraph will be worn continuously from day 5 until the stress test on day 8.
Sleep efficiency
Sleep efficiency will be calculated using the following equation: (total sleep time/total time in bed) * 100.
Measured: Verification period: an actigraph will be worn continuously from day 5 until the end of the verification period. Intervention period: an actigraph will be worn continuously from day 5 until the stress test on day 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start22 Jun 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Hydration StatusStudies 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
- Parallel groups
- Model description
- Participants will be screened to identify habitually low, i.e., total fluid intake: men ≤ 1.6 L/day, women ≤ 1.5 L/day and high i.e., total fluid intake: men ≥ 2.9 L/day, women ≥ 2.5 L/day drinkers. Each subject will undergo two study arms; verification period: 7 days following their habitual daily fluid intake; intervention period: 7-day intervention where daily fluid intake will either be increased (if habitually low), decreased (if habitually high) or maintained at habitual level. The total fluid intake (TFI) prescriptions during the intervention are derived from the mean TFI of habitually high and habitually low drinkers from a sex, age and country matched population. Specifically, habitually high drinkers will be permitted a TFI of 1.3 L/day and habitually low drinkers will be permitted a TFI of 3.5 L/day for men and 3.3 L/day for women. Participants will be instructed to maintain their usual intake of other beverages i.e., tea/coffee to achieve their target TFI.
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D
- Responsible party
- Sponsor
- Investigators
- Neil P Walsh, PhD, Principal investigator, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789847
- Sponsor's protocol ID
- Everyday Hydration Study 1
- Status last verified
- Jun 2026
- First submitted
- 17 Jul 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication(s).
Publications
Lazzarino AI, Hamer M, Gaze D, Collinson P, Steptoe A. The association between cortisol response to mental stress and high-sensitivity cardiac troponin T plasma concentration in healthy adults. J Am Coll Cardiol. 2013 Oct 29;62(18):1694-1701. doi: 10.1016/j.jacc.2013.05.070. Epub 2013 Jun 27.
PubMed 23810896Turner AI, Smyth N, Hall SJ, Torres SJ, Hussein M, Jayasinghe SU, Ball K, Clow AJ. Psychological stress reactivity and future health and disease outcomes: A systematic review of prospective evidence. Psychoneuroendocrinology. 2020 Apr;114:104599. doi: 10.1016/j.psyneuen.2020.104599. Epub 2020 Feb 1.
PubMed 32045797Dhabhar FS. Effects of stress on immune function: the good, the bad, and the beautiful. Immunol Res. 2014 May;58(2-3):193-210. doi: 10.1007/s12026-014-8517-0.
PubMed 24798553Gibbs DM. Vasopressin and oxytocin: hypothalamic modulators of the stress response: a review. Psychoneuroendocrinology. 1986;11(2):131-9. doi: 10.1016/0306-4530(86)90048-x.
PubMed 3018820Roussel R, El Boustany R, Bouby N, Potier L, Fumeron F, Mohammedi K, Balkau B, Tichet J, Bankir L, Marre M, Velho G. Plasma Copeptin, AVP Gene Variants, and Incidence of Type 2 Diabetes in a Cohort From the Community. J Clin Endocrinol Metab. 2016 Jun;101(6):2432-9. doi: 10.1210/jc.2016-1113. Epub 2016 Apr 6.
PubMed 27049477Enhorning S, Struck J, Wirfalt E, Hedblad B, Morgenthaler NG, Melander O. Plasma copeptin, a unifying factor behind the metabolic syndrome. J Clin Endocrinol Metab. 2011 Jul;96(7):E1065-72. doi: 10.1210/jc.2010-2981. Epub 2011 Apr 13.
PubMed 21490073Boertien WE, Riphagen IJ, Drion I, Alkhalaf A, Bakker SJ, Groenier KH, Struck J, de Jong PE, Bilo HJ, Kleefstra N, Gansevoort RT. Copeptin, a surrogate marker for arginine vasopressin, is associated with declining glomerular filtration in patients with diabetes mellitus (ZODIAC-33). Diabetologia. 2013 Aug;56(8):1680-8. doi: 10.1007/s00125-013-2922-0. Epub 2013 Apr 28.
PubMed 23624546Roussel R, Fezeu L, Bouby N, Balkau B, Lantieri O, Alhenc-Gelas F, Marre M, Bankir L; D.E.S.I.R. Study Group. Low water intake and risk for new-onset hyperglycemia. Diabetes Care. 2011 Dec;34(12):2551-4. doi: 10.2337/dc11-0652. Epub 2011 Oct 12.
PubMed 21994426Chan J, Knutsen SF, Blix GG, Lee JW, Fraser GE. Water, other fluids, and fatal coronary heart disease: the Adventist Health Study. Am J Epidemiol. 2002 May 1;155(9):827-33. doi: 10.1093/aje/155.9.827.
PubMed 11978586Allen MD, Springer DA, Burg MB, Boehm M, Dmitrieva NI. Suboptimal hydration remodels metabolism, promotes degenerative diseases, and shortens life. JCI Insight. 2019 Sep 5;4(17):e130949. doi: 10.1172/jci.insight.130949.
PubMed 31484829Sontrop JM, Dixon SN, Garg AX, Buendia-Jimenez I, Dohein O, Huang SH, Clark WF. Association between water intake, chronic kidney disease, and cardiovascular disease: a cross-sectional analysis of NHANES data. Am J Nephrol. 2013;37(5):434-42. doi: 10.1159/000350377. Epub 2013 Apr 17.
PubMed 23594828Clark WF, Sontrop JM, Macnab JJ, Suri RS, Moist L, Salvadori M, Garg AX. Urine volume and change in estimated GFR in a community-based cohort study. Clin J Am Soc Nephrol. 2011 Nov;6(11):2634-41. doi: 10.2215/CJN.01990211. Epub 2011 Sep 1.
PubMed 21885793Ferreira-Pego C, Guelinckx I, Moreno LA, Kavouras SA, Gandy J, Martinez H, Bardosono S, Abdollahi M, Nasseri E, Jarosz A, Babio N, Salas-Salvado J. Total fluid intake and its determinants: cross-sectional surveys among adults in 13 countries worldwide. Eur J Nutr. 2015 Jun;54 Suppl 2(Suppl 2):35-43. doi: 10.1007/s00394-015-0943-9. Epub 2015 Jun 12.
PubMed 26066354Kashi DS, Hunter M, Edwards JP, Zemdegs J, Lourenco J, Mille AC, Perrier ET, Dolci A, Walsh NP. Habitual fluid intake and hydration status influence cortisol reactivity to acute psychosocial stress. J Appl Physiol (1985). 2025 Sep 1;139(3):698-708. doi: 10.1152/japplphysiol.00408.2025. Epub 2025 Aug 13.
PubMed 40803748
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Altering Daily Fluid Intake and Hydration Status Influence Cortisol Reactivity to Acute Psychosocial Stress?
- ClinicalTrials.gov ID
- NCT07789847
- Acronym / sponsor ID
- Everyday Hydration Study 1
- Conditions
- Hydration Status, Psychosocial Stress, Fluid Intake
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Unilever R&D
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 27 Aug 2026 (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.
Over half of the adult population in Europe, Asia and Latin America fail to meet adequate water intake guidelines as advised by the European Food Safety Authority (EFSA; 2.5 and 2 litres/day for men and women, respectively coming from both food and drinks). Increasing epidemiological evidence suggests that chronic low fluid intake may be associated with an increased risk of cardiovascular, metabolic, and renal diseases. The association between chronic low fluid intake and increased morbidity risk may be underpinned by elevations in key water-regulating hormones, such as arginine vasopressin (AVP) and its surrogate copeptin, which influence glucose regulation and renal function. For example, AVP stimulates the hypothalamic-pituitary adrenal (HPA) axis to release the stress hormone cortisol with potentially far-reaching effects on metabolism, immunity and inflammation. Prospective cohort studies have demonstrated that exaggerated cortisol responses to acute stress are associated with poor health outcomes.
A recent cross-sectional study (NCT05491122) from our group found that individuals with a low habitual fluid intake experienced greater cortisol reactivity to acute stress than those with a high habitual intake. The findings of this study may provide a potential explanation for why poor hydration and low fluid intake have negative effects on long-term health. We now aim to explore whether altering fluid intake influences cortisol reactivity to acute stress.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be screened to identify habitually low, i.e., total fluid intake: men ≤ 1.6 L/day, women ≤ 1.5 L/day and high i.e., total fluid intake: men ≥ 2.9 L/day, women ≥ 2.5 L/day drinkers. Each subject will undergo two study arms; verification period: 7 days following their habitual daily fluid intake; intervention period: 7-day intervention where daily fluid intake will either be increased (if habitually low), decreased (if habitually high) or maintained at habitual level. The total fluid intake (TFI) prescriptions during the intervention are derived from the mean TFI of habitually high and habitually low drinkers from a sex, age and country matched population. Specifically, habitually high drinkers will be permitted a TFI of 1.3 L/day and habitually low drinkers will be permitted a TFI of 3.5 L/day for men and 3.3 L/day for women. Participants will be instructed to maintain their usual intake of other beverages i.e., tea/coffee to achieve their target TFI.
| Arm | Type | Receives |
|---|---|---|
| Verification period | No intervention | –7 consecutive days where participants will drink fluids as they do normally do. |
| Intervention period | Experimental | Behavioral: Modifying daily total fluid intake7 consecutive days where the participants will be randomly assigned to either the habitual or intervention condition. * Habitual: maintain their usual daily total fluid intake. * Intervention: habitual low daily TFI will be prescribed a total fluid intake of 3.5 L/day for men and 3.3 L/day for women. Habitual high daily total fluid intake will be prescribed a total fluid intake of 1.3 L/day for both men and women. On day 8, participants will perform a psychosocial stress test. Participants will be instructed to maintain their usual intake of other beverages i.e., tea/coffee to achieve their target total fluid intake. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Individuals who…
Key exclusion criteria (39 listed)
- Individuals who…
- Health screening
- Individuals who…
- …have had any surgery or medical procedure requiring a general anaesthesia in the preceding 4 weeks, or who plan to have one during the study.
- …have an ongoing clinically diagnosed medical condition.
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 |
|---|---|---|
| Modifying daily total fluid intake7-day intervention where the intake of drinking water will either be maintained at habitual level, increased (if habitually low) or decreased (if habitually high). The TFI prescriptions during the intervention are derived from the mean TFI of habitually low and habitually high drinkers from a sex, age and country matched population. Specifically, habitually low drinkers will be permitted a TFI of 3.5 L/day for men and 3.3 L/day for women and habitually high drinkers will be permitted a TFI of 1.3 L/day. Participants will be instructed to maintain their usual intake of other beverages i.e., tea/coffee to achieve their target TFI. | Behavioural | Intervention period |
Primary outcome
Salivary cortisol reactivity to acute psychosocial stress
Time frame: Assessed during the main trial (day 8 of the intervention period). Saliva samples will be taken pre (-30 and -5 minutes) and post (+0, +10, +20, +30, +45 and +60 minutes) stress test.
Changes in the concentration of salivary free cortisol throughout the psychosocial stress test. Cortisol will be measured in stimulated saliva samples and analysed by ELISA. Delta changes (increase/decrease) in cortisol response will also be calculated.
6 secondary outcomes
Plasma copeptin
Time frame: Copeptin will be assessed using a single blood sample taken on the morning of the main trial (day 8 of intervention period).
Urine osmolality (UOsm)
Time frame: Late-afternoon urine samples will be collected on days 6 and 7 of the verification and intervention periods. Spot urine samples will be collected on the morning and afternoon visits of the main trial (day 8 of the intervention period).
Urine colour
Time frame: Late-afternoon urine samples will be collected on days 6 and 7 of the verification and intervention periods. Spot urine samples will be collected on the morning and afternoon visits of the main trial (day 8 of the intervention period).
Plasma osmolality
Time frame: A venous blood sample will be taken on the morning of the main trial (day 8 of the intervention period).
Sleep duration
Time frame: Verification period: an actigraph will be worn continuously from day 5 until the end of the verification period. Intervention period: an actigraph will be worn continuously from day 5 until the stress test on day 8.
Sleep efficiency
Time frame: Verification period: an actigraph will be worn continuously from day 5 until the end of the verification period. Intervention period: an actigraph will be worn continuously from day 5 until the stress test on day 8.
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 27 Aug 2026.
- Background: PubMed 23810896Lazzarino AI, Hamer M, Gaze D, Collinson P, Steptoe A. The association between cortisol response to mental stress and high-sensitivity cardiac troponin T plasma concentration in healthy adults. J Am Coll Cardiol. 2013 Oct 29;62(18):1694-1701. doi: 10.1016/j.jacc.2013.05.070. Epub 2013 Jun 27.
- Background: PubMed 32045797Turner AI, Smyth N, Hall SJ, Torres SJ, Hussein M, Jayasinghe SU, Ball K, Clow AJ. Psychological stress reactivity and future health and disease outcomes: A systematic review of prospective evidence. Psychoneuroendocrinology. 2020 Apr;114:104599. doi: 10.1016/j.psyneuen.2020.104599. Epub 2020 Feb 1.
- Background: PubMed 24798553Dhabhar FS. Effects of stress on immune function: the good, the bad, and the beautiful. Immunol Res. 2014 May;58(2-3):193-210. doi: 10.1007/s12026-014-8517-0.
- Background: PubMed 3018820Gibbs DM. Vasopressin and oxytocin: hypothalamic modulators of the stress response: a review. Psychoneuroendocrinology. 1986;11(2):131-9. doi: 10.1016/0306-4530(86)90048-x.
- Background: PubMed 27049477Roussel R, El Boustany R, Bouby N, Potier L, Fumeron F, Mohammedi K, Balkau B, Tichet J, Bankir L, Marre M, Velho G. Plasma Copeptin, AVP Gene Variants, and Incidence of Type 2 Diabetes in a Cohort From the Community. J Clin Endocrinol Metab. 2016 Jun;101(6):2432-9. doi: 10.1210/jc.2016-1113. Epub 2016 Apr 6.
- Background: PubMed 21490073Enhorning S, Struck J, Wirfalt E, Hedblad B, Morgenthaler NG, Melander O. Plasma copeptin, a unifying factor behind the metabolic syndrome. J Clin Endocrinol Metab. 2011 Jul;96(7):E1065-72. doi: 10.1210/jc.2010-2981. Epub 2011 Apr 13.
- Background: PubMed 23624546Boertien WE, Riphagen IJ, Drion I, Alkhalaf A, Bakker SJ, Groenier KH, Struck J, de Jong PE, Bilo HJ, Kleefstra N, Gansevoort RT. Copeptin, a surrogate marker for arginine vasopressin, is associated with declining glomerular filtration in patients with diabetes mellitus (ZODIAC-33). Diabetologia. 2013 Aug;56(8):1680-8. doi: 10.1007/s00125-013-2922-0. Epub 2013 Apr 28.
- Background: PubMed 21994426Roussel R, Fezeu L, Bouby N, Balkau B, Lantieri O, Alhenc-Gelas F, Marre M, Bankir L; D.E.S.I.R. Study Group. Low water intake and risk for new-onset hyperglycemia. Diabetes Care. 2011 Dec;34(12):2551-4. doi: 10.2337/dc11-0652. Epub 2011 Oct 12.
- Background: PubMed 11978586Chan J, Knutsen SF, Blix GG, Lee JW, Fraser GE. Water, other fluids, and fatal coronary heart disease: the Adventist Health Study. Am J Epidemiol. 2002 May 1;155(9):827-33. doi: 10.1093/aje/155.9.827.
- Background: PubMed 31484829Allen MD, Springer DA, Burg MB, Boehm M, Dmitrieva NI. Suboptimal hydration remodels metabolism, promotes degenerative diseases, and shortens life. JCI Insight. 2019 Sep 5;4(17):e130949. doi: 10.1172/jci.insight.130949.
- Background: PubMed 23594828Sontrop JM, Dixon SN, Garg AX, Buendia-Jimenez I, Dohein O, Huang SH, Clark WF. Association between water intake, chronic kidney disease, and cardiovascular disease: a cross-sectional analysis of NHANES data. Am J Nephrol. 2013;37(5):434-42. doi: 10.1159/000350377. Epub 2013 Apr 17.
- Background: PubMed 21885793Clark WF, Sontrop JM, Macnab JJ, Suri RS, Moist L, Salvadori M, Garg AX. Urine volume and change in estimated GFR in a community-based cohort study. Clin J Am Soc Nephrol. 2011 Nov;6(11):2634-41. doi: 10.2215/CJN.01990211. Epub 2011 Sep 1.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication(s).
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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.
Harry K W Bell, MSc contact
Neil P Walsh, PhD principal investigator
Liverpool John Moores University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modifying daily total fluid intake in people with Hydration Status and Psychosocial Stress, run by Liverpool John Moores 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 14 inclusion and 39 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: looking for participants now, as of the sponsor's last update on 27 Aug 2026. 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 William J Searle, PhD (01519041031, w.j.searle@ljmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary cortisol reactivity to acute psychosocial stress (time frame: Assessed during the main trial (day 8 of the intervention period). Saliva samples will be taken pre (-30 and -5 minutes) and post (+0, +10, +20, +30, +45 and +60 minutes) stress test.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07789847, which also lists 14 linked publications.
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 27 Aug 2026.