Beverage Hydration IndexNCT06967454
Manipulation of Whey Permeate Formulation for Better Fluid Retention.
A study testing Water, Semi-skimmed milk and Whey permeate in people with Beverage Hydration Index, run by Northumbria University at 1 site in United Kingdom.
Trial summary
The main aim of this clinical trial is to compare the beverage hydration index of three different beverages in primary school-aged children.The Beverage Hydration Index (BHI), compares the hydration value of beverages against water. Read more about this study
- Who is it for?
- Ages 9 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Beverage Hydration Index
- What is being tested?
- Water, Semi-skimmed milk and Whey permeate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 May 2025to 25 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 9 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged between 9-11
- Healthy
Who cannot join
- Psychiatric, neurological or mental disorder.
- Children with any morbidity that might influence hydration status (i.e., renal/cardiovascular/metabolic disease), blood-borne illness, or if they were taking any medications that may impact fluid balance.
- Children that are lactose intolerant
- Children that have any food allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Manipulation of Whey Permeate Formulation for Better Fluid Retention
The main aim of this clinical trial is to compare the beverage hydration index of three different beverages in primary school-aged children.The Beverage Hydration Index (BHI), compares the hydration value of beverages against water. This study will explore the fluid retention capabilities of strawberry flavoured semi-skimmed milk, a new formulation of whey permeate based on a previous study, and water.
This study will also investigate:
Read more
- Identify the most effective beverage for hydration and the potential cognitive and mood benefits.
- To test if these beverages have any effect on gastric emptying
- To test if these beverages have any effect on blood glucose.
- To test the acceptability and palpability of semi-skimmed milk, whey permeate, and water in primary school-aged children.
Participants will:
- Take part in three four days (one for each beverage, and a 'low dose' trial, whereby participants will only consume 150ml of the water trial)
- Study day will take part between 9:00AM-12:30PM
- Participants will also record their food and fluid consumption the day before and consume a standardised breakfast before each trial.
- The beverage hydration index will be calculated as the mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment.
- Blood and urine samples will be taken to measure hydration
- Breath samples will be taken for gastric emptying rate
- COMPASS (Computerised Mental Performance Assessment System), fNIRS (Functional Near Infrared Spectroscopy) and visual analogue scales (VAS) measures will be obtained to assess cognition/mood
- An ad libitum pasta meal will be consumed after the trial to measure appetite, along with blood glucose and further VAS to measure self reported hunger and fullness.
- A focus group will be held following completion of all three beverage trials, to gather participants opinion of each drink.
- Conditions
- Beverage Hydration Index
- Being tested
- Water, Semi-skimmed milk, Whey permeate, 'Low dose' water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterOther
Participants will receive 600ml water with a strawberry flavour, in four equal aliquots across 30 minutes (150ml every 7.5minutes)
Semi-skimmed milkOther
Participants will receive 600ml semi skimmed milk with a strawberry flavour, in four equal aliquots across 30 minutes (150ml every 7.5minutes)
Whey permeateOther
Participants will receive 600ml whey permeate with a strawberry flavour, in four equal aliquots across 30 minutes (150ml every 7.5minutes)
'Low dose' waterOther
Participants will receive 150ml water with a strawberry flavour, across 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Beverage 1 | Experimental | Strawberry flavoured Water Receives: Other: Water |
| Beverage 2 | Experimental | Strawberry flavoured milk (Semi Skimmed) Receives: Other: Semi-skimmed milk |
| Beverage 3: Whey permeate | Experimental | Strawberry flavoured whey permeate Receives: Other: Whey permeate |
| 'Low drinkers' trial | Experimental | 150ml only of the strawberry water Receives: Other: 'Low dose' water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beverage Hydration Index
Beverage Hydration index calculated as mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment.
Measured: 0 minutes after beverage consumption
Beverage Hydration Index
Beverage Hydration index calculated as mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment.
Measured: 60 minutes after beverage consumption
Beverage Hydration Index
Beverage Hydration index calculated as mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment.
Measured: 120 minutes after beverage consumption
Secondary outcomes (24)
Net Fluid Balance
Net Fluid balance will be calculated subtracting total urine collected from total liquid consumed
Measured: 0 minutes after beverage consumption
Net Fluid Balance
Net Fluid balance will be calculated subtracting total urine collected from total liquid consumed
Measured: 60 minutes after beverage consumption
Net Fluid Balance
Net Fluid balance will be calculated subtracting total urine collected from total liquid consumed
Measured: 120 minutes after beverage consumption
Urine Osmolality
Urine Osmolality will be measured in milliosmoles per kilogram of water.
Measured: -30 minutes before beverage consumption
Urine Osmolality
Urine Osmolality will be measured in milliosmoles per kilogram of water.
Measured: 0 minutes after beverage consumption
Urine Osmolality
Urine Osmolality will be measured in milliosmoles per kilogram of water.
Measured: 60 minutes after beverage consumption
Urine Osmolality
Urine Osmolality will be measured in milliosmoles per kilogram of water.
Measured: 120 minutes after beverage consumption
Serum Osmolality
Serum Osmolality will be measured in milliosmoles per kilogram of water.
Measured: -30 minutes (before beverage consumption)
Serum Osmolality
Serum Osmolality will be measured in milliosmoles per kilogram of water.
Measured: 0 minutes after beverage consumption
Serum Osmolality
Serum Osmolality will be measured in milliosmoles per kilogram of water.
Measured: 30 minutes after beverage consumption
Serum Osmolality
Serum Osmolality will be measured in milliosmoles per kilogram of water.
Measured: 60 minutes after beverage consumption
Serum Osmolality
Serum Osmolality will be measured in milliosmoles per kilogram of water.
Measured: 120 minutes after beverage consumption
Gastric emptying rate
Test beverages will be infused with 13C-sodium acetate and evaluated using the 13C breath test. Samples will be analysed to determine the ratio of 13CO2 to 12CO2. The change in this ratio from the baseline to post-beverage samples will be expressed as delta over baseline (DOB)
Measured: -30 minutes (before beverage), 15, 30, 45, 60, 75, 90, 105, 120 minutes (after beverage consumption)
Cognitive function
A collection of five cognitive tasks including choice reaction time, simple reaction time, Stroop, Picture recognition and Corsi blocks via Computerised Mental Performance Assessment System (COMPASS)
Measured: -45 minutes (before beverage consumption)
Cognitive function
A collection of five cognitive tasks including choice reaction time, simple reaction time, Stroop, Picture recognition and Corsi blocks via Computerised Mental Performance Assessment System (COMPASS)
Measured: 45 minutes (after beverage consumption)
Cognitive function
A collection of five cognitive tasks including choice reaction time, simple reaction time, Stroop, Picture recognition and Corsi blocks via Computerised Mental Performance Assessment System (COMPASS)
Measured: 105 minutes (after beverage consumption)
Neuroimaging
Functional near-infrared spectroscopy (fNIRS) will monitor changes in the blood oxygenation and blood volume that are related to the human brain function. The headband will be worn whilst participants complete the cognitive tasks.
Measured: -45 minutes (before beverage consumption)
Neuroimaging
Functional near-infrared spectroscopy (fNIRS) will monitor changes in the blood oxygenation and blood volume that are related to the human brain function. The headband will be worn whilst participants complete the cognitive tasks.
Measured: 45 minutes (after beverage consumption)
Neuroimaging
Functional near-infrared spectroscopy (fNIRS) will monitor changes in the blood oxygenation and blood volume that are related to the human brain function. The headband will be worn whilst participants complete the cognitive tasks.
Measured: 105 minutes (after beverage consumption)
Subjective mood and appetite
Mood measured with visual analogue scale (VAS) on 100 mm horizontal lines. Additional VAS will be completed for thirst and appetite. Participants will simply mark a vertical line between the anchored terms, which they feel fittingly, represents how they are feeling at that time. For example, the happiness VAS will have the terms "very happy" printed on the right-hand side of the scale and "very sad" on the left-hand side. The hunger and thirst scales will have 'not hungry or thirsty' printed on the left-hand side and 'very hungry or thirsty' on the right-hand side. A low score will demonstrate that the child had put a mark at the 'not' end of the scale, a high score would show that the child had put a mark at the 'very' end of the scale.
Measured: -30 minutes (before beverage consumption), 0, 45, 105, 120 and 150minutes (after beverage consumption)
Subjective beverage acceptability
Subjective beverage palatability and acceptability measured with visual analogue scale (VAS) on 100 mm horizontal lines. Participants will simply mark a vertical line between the anchored terms, which they feel fittingly, represents how they are feeling at that time. The participants will score terms "sour, sweet, salty, taste, hydrating, stomach bloating, drink again". The score of 0 will indicate they dislike and the score of 100 will indicate they like the beverages.
Measured: 0 minutes (immediately after beverage consumption)
Ad libitum pasta meal
Lunchtime food intake will be assessed from a standardised pasta meal offered ad libitum. Energy intake will be calculated based on the amount consumed and the nutritional information provided Nutritics. The meal will be weighed before and immediately after the participant finished eating.
Measured: 120-150 minutes (after beverage consumption)
Blood glucose
Blood glucose concentrations will be measured instantly using the glucose oxidase method with an automated glucose analyser
Measured: At -30, 0, 60, 120, 150 minutes (before after the ad-libitum lunch meal)
Focus group
After all participants have completed their trials, a focus group will be held to gather the children's options on the drinks.
Measured: Following completion of all beverage trials, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start20 May 2025
- Primary completion24 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beverage Hydration IndexStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Surrey
- Responsible party
- Principal investigator, Catrin Roberts, Northumbria University
- Investigators
- Catrin Roberts, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967454
- Sponsor's protocol ID
- NorthumbriaU (CR/PR/2)
- Status last verified
- Sep 2025
- First submitted
- 12 May 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- 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 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manipulation of Whey Permeate Formulation for Better Fluid Retention
- ClinicalTrials.gov ID
- NCT06967454
- Acronym / sponsor ID
- NorthumbriaU (CR/PR/2)
- Conditions
- Beverage Hydration Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- University of Surrey
- Study start
- 20 May 2025 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 13 May 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.
The main aim of this clinical trial is to compare the beverage hydration index of three different beverages in primary school-aged children.The Beverage Hydration Index (BHI), compares the hydration value of beverages against water. This study will explore the fluid retention capabilities of strawberry flavoured semi-skimmed milk, a new formulation of whey permeate based on a previous study, and water.
This study will also investigate:
- Identify the most effective beverage for hydration and the potential cognitive and mood benefits.
- To test if these beverages have any effect on gastric emptying
- To test if these beverages have any effect on blood glucose.
- To test the acceptability and palpability of semi-skimmed milk, whey permeate, and water in primary school-aged children.
Participants will:
- Take part in three four days (one for each beverage, and a 'low dose' trial, whereby participants will only consume 150ml of the water trial)
- Study day will take part between 9:00AM-12:30PM
- Participants will also record their food and fluid consumption the day before and consume a standardised breakfast before each trial.
- The beverage hydration index will be calculated as the mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment.
- Blood and urine samples will be taken to measure hydration
- Breath samples will be taken for gastric emptying rate
- COMPASS (Computerised Mental Performance Assessment System), fNIRS (Functional Near Infrared Spectroscopy) and visual analogue scales (VAS) measures will be obtained to assess cognition/mood
- An ad libitum pasta meal will be consumed after the trial to measure appetite, along with blood glucose and further VAS to measure self reported hunger and fullness.
- A focus group will be held following completion of all three beverage trials, to gather participants opinion of each drink.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Randomised, crossover design
| Arm | Type | Receives |
|---|---|---|
| Beverage 1 | Experimental | Other: WaterStrawberry flavoured Water |
| Beverage 2 | Experimental | Other: Semi-skimmed milkStrawberry flavoured milk (Semi Skimmed) |
| Beverage 3: Whey permeate | Experimental | Other: Whey permeateStrawberry flavoured whey permeate |
| 'Low drinkers' trial | Experimental | Other: 'Low dose' water150ml only of the strawberry water |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Aged between 9-11
- Healthy
Key exclusion criteria (4 listed)
- Psychiatric, neurological or mental disorder.
- Children with any morbidity that might influence hydration status (i.e., renal/cardiovascular/metabolic disease), blood-borne illness, or if they were taking any medications that may impact fluid balance.
- Children that are lactose intolerant
- Children that have any food allergies
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 |
|---|---|---|
| WaterParticipants will receive 600ml water with a strawberry flavour, in four equal aliquots across 30 minutes (150ml every 7.5minutes) | Other | Beverage 1 |
| Semi-skimmed milkParticipants will receive 600ml semi skimmed milk with a strawberry flavour, in four equal aliquots across 30 minutes (150ml every 7.5minutes) | Other | Beverage 2 |
| Whey permeateParticipants will receive 600ml whey permeate with a strawberry flavour, in four equal aliquots across 30 minutes (150ml every 7.5minutes) | Other | Beverage 3: Whey permeate |
| 'Low dose' waterParticipants will receive 150ml water with a strawberry flavour, across 30 minutes | Other | 'Low drinkers' trial |
Primary outcome
Beverage Hydration Index
Time frame: 0 minutes after beverage consumption
Beverage Hydration index calculated as mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment.
Beverage Hydration Index
Time frame: 60 minutes after beverage consumption
Beverage Hydration index calculated as mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment.
Beverage Hydration Index
Time frame: 120 minutes after beverage consumption
Beverage Hydration index calculated as mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment.
24 secondary outcomes
Net Fluid Balance
Time frame: 0 minutes after beverage consumption
Net Fluid Balance
Time frame: 60 minutes after beverage consumption
Net Fluid Balance
Time frame: 120 minutes after beverage consumption
Urine Osmolality
Time frame: -30 minutes before beverage consumption
Urine Osmolality
Time frame: 0 minutes after beverage consumption
Urine Osmolality
Time frame: 60 minutes after beverage consumption
Urine Osmolality
Time frame: 120 minutes after beverage consumption
Serum Osmolality
Time frame: -30 minutes (before beverage consumption)
Serum Osmolality
Time frame: 0 minutes after beverage consumption
Serum Osmolality
Time frame: 30 minutes after beverage consumption
Serum Osmolality
Time frame: 60 minutes after beverage consumption
Serum Osmolality
Time frame: 120 minutes after beverage consumption
Gastric emptying rate
Time frame: -30 minutes (before beverage), 15, 30, 45, 60, 75, 90, 105, 120 minutes (after beverage consumption)
Cognitive function
Time frame: -45 minutes (before beverage consumption)
Cognitive function
Time frame: 45 minutes (after beverage consumption)
Cognitive function
Time frame: 105 minutes (after beverage consumption)
Neuroimaging
Time frame: -45 minutes (before beverage consumption)
Neuroimaging
Time frame: 45 minutes (after beverage consumption)
Neuroimaging
Time frame: 105 minutes (after beverage consumption)
Subjective mood and appetite
Time frame: -30 minutes (before beverage consumption), 0, 45, 105, 120 and 150minutes (after beverage consumption)
Subjective beverage acceptability
Time frame: 0 minutes (immediately after beverage consumption)
Ad libitum pasta meal
Time frame: 120-150 minutes (after beverage consumption)
Blood glucose
Time frame: At -30, 0, 60, 120, 150 minutes (before after the ad-libitum lunch meal)
Focus group
Time frame: Following completion of all beverage trials, an average of 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Catrin Roberts, PhD principal investigator
Northumbria 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 Water, Semi-skimmed milk and Whey permeate in people with Beverage Hydration Index, run by Northumbria 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 2 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: finished, as of the sponsor's last update on 11 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beverage Hydration Index (time frame: 0 minutes after beverage consumption). The study lists 3 primary outcomes in all. 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 11 Sep 2025.