Clinical trial NCT06967454: Manipulation of Whey Permeate Formulation for Better Fluid Retention.
Official title: Manipulation of Whey Permeate Formulation for Better Fluid Retention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Beverage Hydration Index
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: University of Surrey
First posted: 2025-05-13
Enrollment: 13
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised, crossover design
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Aged between 9-11
* Healthy

Exclusion Criteria:

* 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

Primary outcomes:
measure: Beverage Hydration Index
timeFrame: 0 minutes after beverage consumption
measure: Beverage Hydration Index
timeFrame: 60 minutes after beverage consumption
measure: Beverage Hydration Index
timeFrame: 120 minutes after beverage consumption
Secondary outcomes:
measure: Net Fluid Balance
timeFrame: 0 minutes after beverage consumption
measure: Net Fluid Balance
timeFrame: 60 minutes after beverage consumption
measure: Net Fluid Balance
timeFrame: 120 minutes after beverage consumption
measure: Urine Osmolality
timeFrame: -30 minutes before beverage consumption
measure: Urine Osmolality
timeFrame: 0 minutes after beverage consumption
measure: Urine Osmolality
timeFrame: 60 minutes after beverage consumption
measure: Urine Osmolality
timeFrame: 120 minutes after beverage consumption
measure: Serum Osmolality
timeFrame: -30 minutes (before beverage consumption)
measure: Serum Osmolality
timeFrame: 0 minutes after beverage consumption
measure: Serum Osmolality
timeFrame: 30 minutes after beverage consumption
measure: Serum Osmolality
timeFrame: 60 minutes after beverage consumption
measure: Serum Osmolality
timeFrame: 120 minutes after beverage consumption
measure: Gastric emptying rate
timeFrame: -30 minutes (before beverage), 15, 30, 45, 60, 75, 90, 105, 120 minutes (after beverage consumption)
measure: Cognitive function
timeFrame: -45 minutes (before beverage consumption)
measure: Cognitive function
timeFrame: 45 minutes (after beverage consumption)
measure: Cognitive function
timeFrame: 105 minutes (after beverage consumption)
measure: Neuroimaging
timeFrame: -45 minutes (before beverage consumption)
measure: Neuroimaging
timeFrame: 45 minutes (after beverage consumption)
measure: Neuroimaging
timeFrame: 105 minutes (after beverage consumption)
measure: Subjective mood and appetite
timeFrame: -30 minutes (before beverage consumption), 0, 45, 105, 120 and 150minutes (after beverage consumption)
measure: Subjective beverage acceptability
timeFrame: 0 minutes (immediately after beverage consumption)
measure: Ad libitum pasta meal
timeFrame: 120-150 minutes (after beverage consumption)
measure: Blood glucose
timeFrame: At -30, 0, 60, 120, 150 minutes (before after the ad-libitum lunch meal)
measure: Focus group
timeFrame: Following completion of all beverage trials, an average of 8 weeks
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northumbria University
Study officials:
affiliation: Northumbria University
name: Catrin Roberts, PhD
role: PRINCIPAL_INVESTIGATOR
References: