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A randomised, double-blind, clinical crossover study to assess novel hydration formulations in healthy adults

A randomized, double-blind, clinical crossover study to assess novel hydration formulations for net fluid balance in healthy adults

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000077460
Enrollment
22
Registered
2025-01-24
Start date
2025-01-31
Completion date
2025-04-14
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The research project is looking at whether rehydration drinks can help improve hydration, sleep, and cognitive performance after exercise in hot conditions that cause dehydration. During the study, we will use a controlled method to reduce your body weight by 2% through dehydration. After that, you’ll be given one of four drinks: either a placebo (which contains no active ingredients) or one of three rehydration drinks. These drinks contain a mix of ingredients like electrolytes, vitamins, carbohydrates, proteins, amino acids, and sugar substitutes, all dissolved in water. Each participant will try all four drinks, with at least five days between each trial. We’ll assess how each drink affects your hydration that day, your sleep that night, and your cognitive performance both on the same day and the next day. Since dehydration can affect cognitive performance and sleep quality, we’re hoping these drinks may help with rehydration and recovery. By comparing the different drinks, we hope to discover which ones work best in supporting hydration, sleep, and cognitive performance after dehydration.

Interventions

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 con

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

Sponsors

Australian Catholic University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

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)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026