Liverpool John Moores University
Liverpool, United Kingdom
Location status: Recruiting
NCT Number: NCT07789847
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.
Interested in participating?
Request Info18 year–35 year
All sexes
Interventional
Not applicable
Liverpool, United Kingdom
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Health screening
Individuals who…
Total fluid intake screening
Individuals who…
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.
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.
Time frame: Copeptin will be assessed using a single blood sample taken on the morning of the main trial (day 8 of intervention period).
Plasma copeptin will be analysed by ELISA and compared cross-sectionally between intervention conditions.
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).
The concentration of osmotic solutes present in the urine, measured using a freezing point depression osmometer.
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, 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.
Time frame: A venous blood sample will be taken on the morning of the main trial (day 8 of the intervention period).
A marker of intracellular osmolality, measured using a freezing point depression osmometer. Plasma will be derived from venous blood.
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.
Total sleep time (minutes) will be measured using accelerometery-based movement data recorded using a wrist-worn actigraph.
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 will be calculated using the following equation: (total sleep time/total time in bed) * 100.
Time frame: Assed during the main trial (day 8 of the intervention period). The STAI-S will be administered pre (-30 and -5 minutes) and post (+0, +10, +20, +30, +45 and +60 minutes) stress test.
State anxiety will be assessed throughout the acute stress test using the state aspect (form Y1) of the State-Trait Anxiety Inventory (STAI-S).
Time frame: Assessed during the main trial (day 8 of the intervention period). The Subjective Stress Scale will be administered pre (-30 and -5 minutes) and post (+0, +10, +20, +30, +45 and +60 minutes) post stress test.
Subjective stress will be assessed using the Subjective Stress Scale, a 0-9 Likert scale where participants rate how stressed they feel right now (0 = no subjective stress experience, 4 = moderate subjective stress experience, 9 = extreme subjective stress experience).
Time frame: The STAI-T will be administered once, immediately after enrolling.
Trait anxiety will be measured using the trait aspect (form Y2) of the State-Trait Anxiety Inventory (STAI-T). The STAI-T will be used as a part of participant profiling and demographic assessment.
Time frame: The PSQI will be administered once, immediately after enrolling.
The Pittsburgh Sleep Quality Index (PSQI) will be used to profile participants' sleep quality in the month prior to the study.
Time frame: The PSS will be administered once, immediately after enrolling.
The Perceived Stress Scale (PSS) will be used to profile participants' perceived stress in the month prior to the study.
Time frame: The PSS-week will be administered on the familiarisation visit (between verification and intervention periods) and the morning of the main trial (day 8 of the intervention period).
A modified version of the PSS referring to the "last week" instead of "last month" (PSS-week) will be used to assess perceived stress during the verification and intervention periods.
Time frame: Up to 2 weeks. Assessed daily from day 1-7 of the verification period and day 1-7 of the intervention period.
Participants will rate their sleep quality for the previous night on scale of 1 to 4. 1 = Very Poor, 2 = Poor, 3 = Good, 4 = Very good. This question will be completed as part of a larger daily study diary.
Time frame: The BRUMS will be administered on the familiarisation visit (between verification and intervention periods) and morning of the main trial (day 8 of the intervention period).
The Brunel Mood Scale (BRUMS) will be used to assess mood over the last week, and will be used to characterise mood during the verification and intervention periods.
Time frame: Up to 2 weeks. Assessed daily from day 1-7 of the verification period and day 1-7 of the intervention period.
The number of night time voids will be self-reported, followed by a question assessing how much this bothered the participant on a scale of 1 (Not at all) to 10 (A great deal). These will be completed as part of a larger daily study diary.
Time frame: Continuously measured during the stress test on the main trial (day 8 of the intervention period). Heart rate measurement will start at 30 minutes pre-stress test and continue until 60 minutes post-stress test.
Heart rate will be measured using a telemetric chest strap.
Time frame: Every evening during days 1-7 of the verification and intervention periods.
A subjective rating of thirst will be recorded on a scale from 0 (not thirsty at all) to 7 (very, very thirsty) and a visual analogue scale ranging from "not thirsty" to "very thirsty". The ratings will be completed in the evening (approx. 30 min before bed) as part of a larger daily study diary.
Time frame: Up to 15 days. Daily from day 1 to 7 of the verification period and day 1 to 8 of the intervention period.
TFI will be recorded as part of a larger daily study diary. For this study, TFI refers to all drinks consumed e.g., water, tea/coffee, milk, juice, soft drinks and alcohol. Each drink will be recorded as close to the time of consumption as possible.
Time frame: The SkinCARE Questionnaire will be administered once, during the familiarisation visit (between verification and intervention periods).
The SkinCARE Questionnaire will be used to profile participants for self-reported skin issues experienced in the previous 4 weeks.
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
Actigraphy data analysed to estimate physical activity
Interested in participating?
Request InfoLiverpool John Moores University
Other
Does Altering Daily Fluid Intake and Hydration Status Influence Cortisol Reactivity to Acute Psychosocial Stress?
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