CompletedNot Applicable

Manipulation of Whey Permeate Formulation for Better Fluid Retention.

United Kingdom13 participantsStarted 2025-05-20

Plain-language 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.

Who can participate

Age range

9 Years – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Beverage Hydration Index

Timeframe: 0 minutes after beverage consumption

Beverage Hydration Index

Timeframe: 60 minutes after beverage consumption

Beverage Hydration Index

Timeframe: 120 minutes after beverage consumption

Trial details

NCT IDNCT06967454

SponsorNorthumbria University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-24

View on ClinicalTrials.gov More Beverage Hydration Index trials

Plain-language summary

Who can participate

Age range

9 Years – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.