Manipulation of Whey Permeate Formulation for Better Fluid Retention.

NCT06967454 | Completed

• 1 other identifier: NorthumbriaU (CR/PR/2)
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Beverage Hydration Index

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  120 minutes after beverage consumption

Secondary Outcomes (24)

• Net Fluid Balance

  0 minutes after beverage consumption

• Net Fluid Balance

  60 minutes after beverage consumption

• Net Fluid Balance

  120 minutes after beverage consumption

• Urine Osmolality

  -30 minutes before beverage consumption

• Urine Osmolality

  0 minutes after beverage consumption

Study Arms (4)

Beverage 1

EXPERIMENTAL

Strawberry flavoured Water

Other: Water

Beverage 2

EXPERIMENTAL

Strawberry flavoured milk (Semi Skimmed)

Other: Semi-skimmed milk

Beverage 3: Whey permeate

EXPERIMENTAL

Strawberry flavoured whey permeate

Other: Whey permeate

'Low drinkers' trial

EXPERIMENTAL

150ml only of the strawberry water

Other: 'Low dose' water

Interventions

Water OTHER

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

Beverage 1

Semi-skimmed milk OTHER

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

Beverage 2

Whey permeate OTHER

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

Beverage 3: Whey permeate

'Low dose' water OTHER

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

'Low drinkers' trial

Eligibility Criteria

• Age: 9 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged between 9-11
• Healthy

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead
• University of Surrey: collaborator

Study Sites (1)

Northumbria University

Newcastle upon Tyne, United Kingdom

Location

MeSH Terms

Interventions

Water; Diet, Fat-Restricted

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Catrin Roberts, PhD

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Test beverages were presented to the participant in a dark bottle, and were not told which beverage they were consuming for each trial.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: Randomised, crossover design

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 13, 2025
• Study Start: May 20, 2025
• Primary Completion: June 24, 2025
• Study Completion: June 25, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)