Manipulation of Whey Permeate Formulation for Better Fluid Retention.

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.

Conditions

• Beverage Hydration Index

Interventions

OTHER

Water

Participants will receive 600ml water with a strawberry flavour, in four equal aliquots across 30 minutes (150ml every 7.5minutes)

OTHER

Semi-skimmed milk

Participants will receive 600ml semi skimmed milk with a strawberry flavour, in four equal aliquots across 30 minutes (150ml every 7.5minutes)

OTHER

Whey permeate

Participants will receive 600ml whey permeate with a strawberry flavour, in four equal aliquots across 30 minutes (150ml every 7.5minutes)

OTHER

'Low dose' water

Participants will receive 150ml water with a strawberry flavour, across 30 minutes

Sponsors & Collaborators

• University of Surrey

  collaborator OTHER

• Northumbria University

  lead OTHER

Principal Investigators

• Catrin Roberts, PhD · Northumbria University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

9 Years

Max Age

11 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-05-20

Primary Completion

2025-06-24

Completion

2025-06-25

Countries

• United Kingdom

Study Locations