Manipulation of Whey Permeate Formulation for Better Fluid Retention.

Northumbria University

Status: Completed

Conditions: Beverage Hydration Index

Treatments: Other: Whey permeate; Other: 'Low dose' water; Other: Semi-skimmed milk; Other: Water

Study type: Interventional

Funder types: Other

Identifiers

NCT06967454

NorthumbriaU (CR/PR/2)

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 9 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

13 participants in 4 patient groups

Beverage 1

Experimental group

Description:

Strawberry flavoured Water

Treatment:

Other: Water

Beverage 2

Experimental group

Description:

Strawberry flavoured milk (Semi Skimmed)

Treatment:

Other: Semi-skimmed milk

Beverage 3: Whey permeate

Experimental group

Description:

Strawberry flavoured whey permeate

Treatment:

Other: Whey permeate

'Low drinkers' trial

Experimental group

Description:

150ml only of the strawberry water

Treatment:

Other: 'Low dose' water