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Completed

NCT Number: NCT06967454

Manipulation of Whey Permeate Formulation for Better Fluid Retention.

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.

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Key information

Conditions

Beverage Hydration Index

Age range

9 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northumbria University

Newcastle upon Tyne, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water

Other

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

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)

Whey permeate

Other

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

'Low dose' water

Other

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

Primary outcomes

  1. Beverage Hydration Index

    Time frame: 0 minutes after beverage consumption

    Beverage Hydration index calculated as mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment.

  2. Beverage Hydration Index

    Time frame: 60 minutes after beverage consumption

    Beverage Hydration index calculated as mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment.

  3. Beverage Hydration Index

    Time frame: 120 minutes after beverage consumption

    Beverage Hydration index calculated as mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment.

Secondary outcomes

  1. Net Fluid Balance

    Time frame: 0 minutes after beverage consumption

    Net Fluid balance will be calculated subtracting total urine collected from total liquid consumed

  2. Net Fluid Balance

    Time frame: 60 minutes after beverage consumption

    Net Fluid balance will be calculated subtracting total urine collected from total liquid consumed

  3. Net Fluid Balance

    Time frame: 120 minutes after beverage consumption

    Net Fluid balance will be calculated subtracting total urine collected from total liquid consumed

  4. Urine Osmolality

    Time frame: -30 minutes before beverage consumption

    Urine Osmolality will be measured in milliosmoles per kilogram of water.

  5. Urine Osmolality

    Time frame: 0 minutes after beverage consumption

    Urine Osmolality will be measured in milliosmoles per kilogram of water.

  6. Urine Osmolality

    Time frame: 60 minutes after beverage consumption

    Urine Osmolality will be measured in milliosmoles per kilogram of water.

  7. Urine Osmolality

    Time frame: 120 minutes after beverage consumption

    Urine Osmolality will be measured in milliosmoles per kilogram of water.

  8. Serum Osmolality

    Time frame: -30 minutes (before beverage consumption)

    Serum Osmolality will be measured in milliosmoles per kilogram of water.

  9. Serum Osmolality

    Time frame: 0 minutes after beverage consumption

    Serum Osmolality will be measured in milliosmoles per kilogram of water.

  10. Serum Osmolality

    Time frame: 30 minutes after beverage consumption

    Serum Osmolality will be measured in milliosmoles per kilogram of water.

  11. Serum Osmolality

    Time frame: 60 minutes after beverage consumption

    Serum Osmolality will be measured in milliosmoles per kilogram of water.

  12. Serum Osmolality

    Time frame: 120 minutes after beverage consumption

    Serum Osmolality will be measured in milliosmoles per kilogram of water.

  13. Gastric emptying rate

    Time frame: -30 minutes (before beverage), 15, 30, 45, 60, 75, 90, 105, 120 minutes (after beverage consumption)

    Test beverages will be infused with 13C-sodium acetate and evaluated using the 13C breath test. Samples will be analysed to determine the ratio of 13CO2 to 12CO2. The change in this ratio from the baseline to post-beverage samples will be expressed as delta over baseline (DOB)

  14. Cognitive function

    Time frame: -45 minutes (before beverage consumption)

    A collection of five cognitive tasks including choice reaction time, simple reaction time, Stroop, Picture recognition and Corsi blocks via Computerised Mental Performance Assessment System (COMPASS)

  15. Cognitive function

    Time frame: 45 minutes (after beverage consumption)

    A collection of five cognitive tasks including choice reaction time, simple reaction time, Stroop, Picture recognition and Corsi blocks via Computerised Mental Performance Assessment System (COMPASS)

  16. Cognitive function

    Time frame: 105 minutes (after beverage consumption)

    A collection of five cognitive tasks including choice reaction time, simple reaction time, Stroop, Picture recognition and Corsi blocks via Computerised Mental Performance Assessment System (COMPASS)

  17. Neuroimaging

    Time frame: -45 minutes (before beverage consumption)

    Functional near-infrared spectroscopy (fNIRS) will monitor changes in the blood oxygenation and blood volume that are related to the human brain function. The headband will be worn whilst participants complete the cognitive tasks.

  18. Neuroimaging

    Time frame: 45 minutes (after beverage consumption)

    Functional near-infrared spectroscopy (fNIRS) will monitor changes in the blood oxygenation and blood volume that are related to the human brain function. The headband will be worn whilst participants complete the cognitive tasks.

  19. Neuroimaging

    Time frame: 105 minutes (after beverage consumption)

    Functional near-infrared spectroscopy (fNIRS) will monitor changes in the blood oxygenation and blood volume that are related to the human brain function. The headband will be worn whilst participants complete the cognitive tasks.

  20. Subjective mood and appetite

    Time frame: -30 minutes (before beverage consumption), 0, 45, 105, 120 and 150minutes (after beverage consumption)

    Mood measured with visual analogue scale (VAS) on 100 mm horizontal lines. Additional VAS will be completed for thirst and appetite. Participants will simply mark a vertical line between the anchored terms, which they feel fittingly, represents how they are feeling at that time. For example, the happiness VAS will have the terms "very happy" printed on the right-hand side of the scale and "very sad" on the left-hand side. The hunger and thirst scales will have 'not hungry or thirsty' printed on the left-hand side and 'very hungry or thirsty' on the right-hand side. A low score will demonstrate that the child had put a mark at the 'not' end of the scale, a high score would show that the child had put a mark at the 'very' end of the scale.

  21. Subjective beverage acceptability

    Time frame: 0 minutes (immediately after beverage consumption)

    Subjective beverage palatability and acceptability measured with visual analogue scale (VAS) on 100 mm horizontal lines. Participants will simply mark a vertical line between the anchored terms, which they feel fittingly, represents how they are feeling at that time. The participants will score terms "sour, sweet, salty, taste, hydrating, stomach bloating, drink again". The score of 0 will indicate they dislike and the score of 100 will indicate they like the beverages.

  22. Ad libitum pasta meal

    Time frame: 120-150 minutes (after beverage consumption)

    Lunchtime food intake will be assessed from a standardised pasta meal offered ad libitum. Energy intake will be calculated based on the amount consumed and the nutritional information provided Nutritics. The meal will be weighed before and immediately after the participant finished eating.

  23. Blood glucose

    Time frame: At -30, 0, 60, 120, 150 minutes (before after the ad-libitum lunch meal)

    Blood glucose concentrations will be measured instantly using the glucose oxidase method with an automated glucose analyser

  24. Focus group

    Time frame: Following completion of all beverage trials, an average of 8 weeks

    After all participants have completed their trials, a focus group will be held to gather the children's options on the drinks.

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Collaborators

  • University of Surrey

Registry information

Official study title

Manipulation of Whey Permeate Formulation for Better Fluid Retention

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 13, 2025
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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