Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000077460p
Ethics application status
Submitted, not yet approved
Date submitted
9/12/2024
Date registered
24/01/2025
Date last updated
24/01/2025
Date data sharing statement initially provided
24/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised, double-blind, clinical crossover study to assess novel hydration formulations in healthy adults
Scientific title
A randomized, double-blind, clinical crossover study to assess novel hydration formulations for net fluid balance in healthy adults
Secondary ID [1] 313537 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deyhdration 336007 0
Reyhdration 336008 0
Sleep quantity 336009 0
Sleep quality 336107 0
Cognitive performance 336108 0
Condition category
Condition code
Metabolic and Endocrine 332588 332588 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dehydration Protocol
Participants will enter the heat chamber and remain in the chamber until a reduction of 2% of body weight is attained. Participants will cycle on an ergometer (Wattbike Trainer; Wattbike Ltd, United Kingdom) at 70-80% HRmax for 60 to 120 minutes in the heat chamber (30°C, 50% rh) and interrupted at regular 15-minute intervals for weighing and for tympanic temperature to be evaluated. Participants will be asked to towel dry immediately prior to weighing. No fluid will be consumed while in the heat chamber and it is expected to take between 60 and 120 minutes to attain the target body mass loss. Upon completion of heat exposure, subjects will be instructed to sit for 10 minutes, void their bladder, and towel dry, before being weighed again.

Rehydration Protocol
After leaving the heat chamber, subjects will consume an intervention (either formulation 1, 2, 3 or placebo) which will be provided as a drink according to condition with a target of replenishing ~150% of the fluid lost during exercise. Fluid replacement targets will be determined by measuring the change in body mass across the exercise protocol (e.g., a 1 kg body mass loss will mean a 1.5 L rehydration target). The drinks will be provided to participants divided into 3 equal portions with each portion consumed over 10 minutes with 15 minutes between portions, for a total rehydration period of 60 minutes. Participants will be monitored in the laboratory for 5.5 hours following completion of the cycling protocol. Participants will be in the laboratory for approximately 7 to 8 hours for each condition.

Each participant will consume formulation 1, formulation 2, formulation 3, and the placebo once each. Condition days will be separated with a minimum washout period of five days with a total study time of approximately 20 days. The formulations are as follows:
Formulations 1-3; to be dissolved in water
Formula 1
• Sodium 700 mg
• Potassium 380 mg
• Vitamin C 76 mg
• Vitamin B3 15 mg
• Vitamin B5 5 mg
• Vitamin B6 1.4 mg
• Vitamin B12 2.4 mcg
Proprietary blend: soy powder, erythritol, glutamine, magnesium, calcium
Other ingredients: citric acid, silicon dioxide, stevia, flavor

Formula 2
• Sodium 510 mg
• Potassium 380 mg
• Vitamin C 76 mg
• Vitamin B3 24.9 mg
• Vitamin B5 11.7 mg
• Vitamin B6 2.53 mg
• Vitamin B12 8 mcg
Proprietary blend: glutamine, alanine, allulose
Other ingredients: citric acid, silicon dioxide, stevia, flavor

Formula 3
• Sodium 510 mg
• Potassium 380 mg
• Vitamin C 76 mg
• Vitamin B3 24.9 mg
• Vitamin B5 11.7 mg
• Vitamin B12 8 mcg
Proprietary blend: glutamine, alanine, arginine, lysine, serine, threonine, magnesium, calcium
Other ingredients: citric acid, silicon dioxide, stevia, flavor
Intervention code [1] 330125 0
Treatment: Other
Comparator / control treatment
Placebo: Taste-matched powder / flavored liquid with no active ingredients dissolved in water
Control group
Placebo

Outcomes
Primary outcome [1] 340098 0
Net fluid balance
Timepoint [1] 340098 0
Immediately prior to dehydration protocol, every 15-minutes while in the heat chamber, immediately following the completion of cycling, 30 minutes upon completion of cycling, immediately at the start of the 5-hour rehydration period, and every hour throughout the 5-hour rehydration period
Secondary outcome [1] 442648 0
Urine specific gravity (unitless ratio)
Timepoint [1] 442648 0
Immediately prior to dehydration protocol, immediately following the completion of cycling, 30 minutes upon completion of cycling, every hour throughout rehydration period, immediately at the start of the 5-hour rehydration period, and every hour throughout the 5-hour rehydration period
Secondary outcome [2] 442649 0
Urine osmolarity (mOsm·kg-1)
Timepoint [2] 442649 0
Immediately prior to dehydration protocol, immediately following the completion of cycling, 30 minutes upon completion of cycling, every hour throughout rehydration period, immediately at the start of the 5-hour rehydration period, and every hour throughout the 5-hour rehydration period
Secondary outcome [3] 442650 0
Plasma volume measured as haematocrit (%)
Timepoint [3] 442650 0
Immediately prior to dehydration protocol, immediately following the completion of cycling, 30 minutes upon completion of cycling, every hour throughout rehydration period, immediately at the start of the 5-hour rehydration period, and every hour throughout the 5-hour rehydration period
Secondary outcome [4] 442651 0
Urine volume (mL)
Timepoint [4] 442651 0
In addition to the rehydration period, also collect any urine produced during the evening and upon waking the next morning.
Secondary outcome [5] 442652 0
Total sleep time (minutes)
Timepoint [5] 442652 0
Continuously for the duration of night-time sleep on a condition day until waking up the next morning
Secondary outcome [6] 442654 0
Sleep efficiency (%)
Timepoint [6] 442654 0
Continuously for the duration of night-time sleep on a condition day until waking up the next morning
Secondary outcome [7] 442655 0
Sleep onset latency (minutes)
Timepoint [7] 442655 0
Continuously for the duration of night-time sleep on a condition day until waking up the next morning
Secondary outcome [8] 442656 0
Wake after sleep onset (minutes)
Timepoint [8] 442656 0
Continuously for the duration of night-time sleep on a condition day until waking up the next morning
Secondary outcome [9] 442657 0
Duration of N1, N2, N3, and REM sleep (minutes)
Timepoint [9] 442657 0
Continuously for the duration of night-time sleep on a condition day until waking up the next morning
Secondary outcome [10] 442658 0
Proportion of N1, N2, N3, and REM sleep relative to total sleep time (%)
Timepoint [10] 442658 0
Continuously for the duration of night-time sleep on a condition day until waking up the next morning
Secondary outcome [11] 442659 0
Heart rate (bpm)
Timepoint [11] 442659 0
Continuously for the duration of night-time sleep on a condition day until waking up the next morning
Secondary outcome [12] 442660 0
Heart rate variability (rmssd)
Timepoint [12] 442660 0
Continuously for the duration of night-time sleep on a condition day until waking up the next morning
Secondary outcome [13] 442663 0
Subjective total sleep time (minutes)
Timepoint [13] 442663 0
Continuously for the duration of night-time sleep on a condition day until waking up the next morning
Secondary outcome [14] 442664 0
Subjective sleep efficiency (%)
Timepoint [14] 442664 0
Continuously for the duration of night-time sleep on a condition day until waking up the next morning
Secondary outcome [15] 442665 0
Subjective sleep onset latency (minutes)
Timepoint [15] 442665 0
Assessed upon waking up the next morning (within 30 minutes)
Secondary outcome [16] 442667 0
Subjective wake after sleep onset (minutes)
Timepoint [16] 442667 0
Assessed upon waking up the next morning (within 30 minutes)
Secondary outcome [17] 442668 0
Subjective sleep quality (1-5 Likert scale)
Timepoint [17] 442668 0
Assessed upon waking up the next morning (within 30 minutes)
Secondary outcome [18] 442670 0
Reaction time (ms)
Timepoint [18] 442670 0
Immediately prior to dehydration protocol, immediately following the completion of cycling, 30 minutes upon completion of cycling, every hour throughout rehydration period, immediately at the start of the 5-hour rehydration period, every hour throughout the 5-hour rehydration period , 15 minutes prior to bedtime, and 15 minutes upon waking the following morning.
Secondary outcome [19] 442672 0
Number of lapses (count)
Timepoint [19] 442672 0
Immediately prior to dehydration protocol, immediately following the completion of cycling, 30 minutes upon completion of cycling, every hour throughout rehydration period, immediately at the start of the 5-hour rehydration period, every hour throughout the 5-hour rehydration period , 15 minutes prior to bedtime, and 15 minutes upon waking the following morning.
Secondary outcome [20] 442673 0
Number of errors (count)
Timepoint [20] 442673 0
Immediately prior to dehydration protocol, immediately following the completion of cycling, 30 minutes upon completion of cycling, every hour throughout rehydration period, immediately at the start of the 5-hour rehydration period, every hour throughout the 5-hour rehydration period , 15 minutes prior to bedtime, and 15 minutes upon waking the following morning.
Secondary outcome [21] 442674 0
Proportion (%) of correct responses for all trials, congruent trials (colour/word match), and incongruent trials (colour/word mismatch)
Timepoint [21] 442674 0
Immediately prior to dehydration protocol, immediately following the completion of cycling, 30 minutes upon completion of cycling, every hour throughout rehydration period, immediately at the start of the 5-hour rehydration period, every hour throughout the 5-hour rehydration period , 15 minutes prior to bedtime, and 15 minutes upon waking the following morning.
Secondary outcome [22] 442675 0
Reaction time (ms) of correct responses for all trials, congruent trials (colour/word match), and incongruent trials (colour/word mismatch)
Timepoint [22] 442675 0
Immediately prior to dehydration protocol, immediately following the completion of cycling, 30 minutes upon completion of cycling, every hour throughout rehydration period, immediately at the start of the 5-hour rehydration period, every hour throughout the 5-hour rehydration period , 15 minutes prior to bedtime, and 15 minutes upon waking the following morning.
Secondary outcome [23] 442676 0
Mean difference between response time for congruent and incongruent trials (Simon effect) (ms)
Timepoint [23] 442676 0
Immediately prior to dehydration protocol, immediately following the completion of cycling, 30 minutes upon completion of cycling, every hour throughout rehydration period, immediately at the start of the 5-hour rehydration period, every hour throughout the 5-hour rehydration period , 15 minutes prior to bedtime, and 15 minutes upon waking the following morning.
Secondary outcome [24] 442677 0
Level of thirst (AU)
Timepoint [24] 442677 0
Immediately prior to dehydration protocol, immediately following the completion of cycling, 30 minutes upon completion of cycling, every hour throughout rehydration period, immediately at the start of the 5-hour rehydration period, every hour throughout the 5-hour rehydration period , 15 minutes prior to bedtime, and 15 minutes upon waking the following morning.
Secondary outcome [25] 442678 0
Level of fatigue (AU)
Timepoint [25] 442678 0
Immediately prior to dehydration protocol, immediately following the completion of cycling, 30 minutes upon completion of cycling, every hour throughout rehydration period, immediately at the start of the 5-hour rehydration period, every hour throughout the 5-hour rehydration period , 15 minutes prior to bedtime, and 15 minutes upon waking the following morning.
Secondary outcome [26] 442679 0
How positive overall mood is (AU)
Timepoint [26] 442679 0
Immediately prior to dehydration protocol, immediately following the completion of cycling, 30 minutes upon completion of cycling, every hour throughout rehydration period, immediately at the start of the 5-hour rehydration period, every hour throughout the 5-hour rehydration period , 15 minutes prior to bedtime, and 15 minutes upon waking the following morning.
Secondary outcome [27] 442680 0
Readiness to perform (AU)
Timepoint [27] 442680 0
Immediately prior to dehydration protocol, immediately following the completion of cycling, 30 minutes upon completion of cycling, every hour throughout rehydration period, immediately at the start of the 5-hour rehydration period, every hour throughout the 5-hour rehydration period , 15 minutes prior to bedtime, and 15 minutes upon waking the following morning.
Secondary outcome [28] 442681 0
Perception of condition
Timepoint [28] 442681 0
Conclusion of study (one day post last condition day)
Secondary outcome [29] 442682 0
Daily food and beverage intake
Timepoint [29] 442682 0
Day prior to and day of each condition.
Secondary outcome [30] 442683 0
Tympanic temperature (°C)
Timepoint [30] 442683 0
Every 10 minutes during the dehydration protocol.
Secondary outcome [31] 442684 0
Heart rate (bpm)
Timepoint [31] 442684 0
Every 10 minutes during the dehydration protocol
Secondary outcome [32] 442685 0
Rating of perceived exertion (RPE) (AU)
Timepoint [32] 442685 0
Every 10 minutes during the dehydration protocol.

Eligibility
Key inclusion criteria
- Must be able to provide written informed consent upon having the study procedure explained to them verbally and in writing
- Healthy adult male and female participants (assessed via initial screening questionnaire), the 12-item General Health Questionnaire, and the Exercise and Sports Science (ESSA) pre-screening tool
- Aged between 18 and 40 years (inclusive)
- Free from any known sleep disorders or disturbances (assessed via the Pittsburgh Sleep Quality Index with a score equal to or less than 5)
- If a regular caffeine consumer, has a habitual consumption between two to five mg·kg·day-1 (assessed via validated caffeine intake questionnaire)
- Non-smoker
- Willing to refrain from consuming alcohol and sports drinks on the day prior to and the day of each condition
- Willing to refrain from napping and strenuous exercise on the day prior to and the day of each condition
- If a regular caffeine consumer, willing to consume a standardised dose of caffeine on the morning prior to and morning of each condition and refrain from additional caffeine intake on these days.
- Must be willing to consume standardised diet and fluid intake on each condition day
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Participant has a known medical condition or current illness that may affect sleep or prohibit their participation in the dehydration protocol
- Participant has signs or symptoms of disease which may place participant at a high risk of an adverse event if participating in exercise
- Participant has a known kidney dysfunction
- A naturally cycling female who does not report a natural menstrual cycle of 21 to 35 days based off the calendar counting method
- Participant has a clinically diagnosed sleeping disorder
- Participant has consumed cigarettes, drugs, medications, or supplements known to affect sleep, hydration status, or heat tolerance in the month prior to study admission or will consume these during the study
o Drugs or medications: Including but not limited to tobacco or electronic inhalable, illegal drugs, prescribed marijuana, selective serotonin uptake inhibitors (SSRI), apremilast, corticosteroids (systemic use), diuretics, laxatives, muscle relaxants, opioid painkillers, and statins
o Supplements: Including but not limited to calcium, melatonin, dandelion, lithium orotate, potassium citrate, and watercress
- Participant has undertaken overnight shift work in the three months prior to study admission
- Participant has undertaken international time zone travel in the three months prior to study admission
- Participant has a known sensitivity, intolerability, or allergy to any of the study products or their excipients, or any of the rescue medications
- Participant is scheduled for any medical or other health-related procedures during the study period
- The visit to the laboratory will be rescheduled if the individual’s urine showed USG values indicative of dehydration (USG > 1.020)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Latin Square Design using random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
27
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317994 0
Commercial sector/Industry
Name [1] 317994 0
Unilever Health and Wellbeing
Country [1] 317994 0
United Kingdom
Primary sponsor type
University
Name
Australian Catholic University
Address
Country
Australia
Secondary sponsor category [1] 320338 0
None
Name [1] 320338 0
Address [1] 320338 0
Country [1] 320338 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316661 0
ACU Human Research Ethics Committee
Ethics committee address [1] 316661 0
Ethics committee country [1] 316661 0
Australia
Date submitted for ethics approval [1] 316661 0
25/10/2024
Approval date [1] 316661 0
Ethics approval number [1] 316661 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138574 0
Prof Shona Halson
Address 138574 0
Australian Catholic University, 1100 Nudgee Road QLD 4014
Country 138574 0
Australia
Phone 138574 0
+61 422224491
Fax 138574 0
Email 138574 0
[email protected]
Contact person for public queries
Name 138575 0
Carissa Gardiner
Address 138575 0
Australian Catholic University, 1100 Nudgee Road QLD 4014
Country 138575 0
Australia
Phone 138575 0
+61 439833967
Fax 138575 0
Email 138575 0
[email protected]
Contact person for scientific queries
Name 138576 0
Carissa Gardiner
Address 138576 0
Australian Catholic University, 1100 Nudgee Road QLD 4014
Country 138576 0
Australia
Phone 138576 0
+61 439833967
Fax 138576 0
Email 138576 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.