- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06711926
Influence of Beverage Choice on Hydration Status Cognition and Learning in Children
Influence of School Beverage Choice on Hydration Status Cognition and Learning in Primary School Aged Children
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 plain water. This study will explore the fluid retention capabilities of semi-skimmed milk, milk permeate, 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 appetite.
- To test the acceptability and palpability of semi-skimmed milk, milk permeate, and water in primary school-aged children.
Participants will:
- Take part in three study days (one for each beverage)
- 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 GLP-1 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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Newcastle upon Tyne, United Kingdom
- Northumbria University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: Beverage 1
Distilled water
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Participants will receive 600ml distilled water with a strawberry flavour, in four equal aliquots across 30 minutes (150ml every 7.5minutes)
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Experimental: Experimental: Beverage 2
Semi skimmed milk
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Participants will receive ~600ml semi-skimmed milk with a strawberry flavour in four equal aliquots across 30minutes (150ml every 7.5minutes).
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|
Experimental: Experimental: Beverage 3
Whey permeate
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Participants will receive ~600ml whey permeate (30g sachet, rehydrated with distilled water)with strawberry flavour in four equal aliquots across 30minutes (150ml every 7.5minutes).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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0 minutes after beverage consumption
|
|
Beverage hydration index
Time Frame: 60 minutes after beverage consumption
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Beverage Hydration index calculated as mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment.
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60 minutes after beverage consumption
|
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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.
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120 minutes after beverage consumption
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Net Fluid Balance
Time Frame: 0 minutes after beverage consumption
|
Net Fluid balance will be calculated subtracting total urine collected from total liquid consumed
|
0 minutes after beverage consumption
|
|
Urine Osmolality
Time Frame: 0 minutes after beverage consumption
|
Urine Osmolality will be measured in milliosmoles per kilogram of water.
|
0 minutes after beverage consumption
|
|
Urine Osmolality
Time Frame: 60 minutes after beverage consumption
|
Urine Osmolality will be measured in milliosmoles per kilogram of water.
|
60 minutes after beverage consumption
|
|
Urine Osmolality
Time Frame: 120 minutes after beverage consumption
|
Urine Osmolality will be measured in milliosmoles per kilogram of water.
|
120 minutes after beverage consumption
|
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Net Fluid Balance
Time Frame: 60 minutes after beverage consumption
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Net Fluid balance will be calculated subtracting total urine collected from total
|
60 minutes after beverage consumption
|
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Net Fluid Balance
Time Frame: 120 minutes after beverage consumption
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Net Fluid balance will be calculated subtracting total urine collected from total
|
120 minutes after beverage consumption
|
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Urine Osmolality
Time Frame: -30 minutes before beverage consumption
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Urine Osmolality will be measured in milliosmoles per kilogram of water.
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-30 minutes before beverage consumption
|
|
Serum osmolality
Time Frame: -30 minutes (before beverage consumption)
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Serum Osmolality will be measured in milliosmoles per kilogram of water.
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-30 minutes (before beverage consumption)
|
|
Serum Osmolality
Time Frame: 0 minutes after beverage consumption
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Serum Osmolality will be measured in milliosmoles per kilogram of water.
|
0 minutes after beverage consumption
|
|
Serum Osmolality
Time Frame: 30 minutes after beverage consumption
|
Serum Osmolality will be measured in milliosmoles per kilogram of water.
|
30 minutes after beverage consumption
|
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Serum Osmolality
Time Frame: 60 minutes after beverage consumption
|
Serum Osmolality will be measured in milliosmoles per kilogram of water.
|
60 minutes after beverage consumption
|
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Serum Osmolality
Time Frame: 120 minutes after beverage consumption
|
Serum Osmolality will be measured in milliosmoles per kilogram of water.
|
120 minutes after beverage consumption
|
|
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).
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-30 minutes (before beverage), 15, 30, 45, 60, 75, 90, 105, 120 minutes (after beverage consumption).
|
|
Cognitive function
Time Frame: -45 minutes (before beverage consumption)
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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)
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-45 minutes (before beverage consumption)
|
|
Cognitive function
Time Frame: 45 minutes (after beverage consumption)
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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)
|
45 minutes (after beverage consumption)
|
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Cognitive function
Time Frame: 105 minutes (after beverage consumption)
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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)
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105 minutes (after beverage consumption)
|
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Neuroimaging
Time Frame: -45 minutes (before beverage consumption)
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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.
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-45 minutes (before beverage consumption)
|
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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.
|
45 minutes (after beverage consumption)
|
|
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.
|
105 minutes (after beverage consumption)
|
|
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.
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-30 minutes (before beverage consumption), 0, 45, 105, 120 and 150minutes (after beverage consumption)
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Subjective beverage acceptability
Time Frame: 0 minutes (immediately after beverage consumption)
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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.
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0 minutes (immediately after beverage consumption)
|
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Ad libitum meal
Time Frame: 120-150 minutes (after beverage consumption)
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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.
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120-150 minutes (after beverage consumption)
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Blood glucose
Time Frame: At 120 minutes and 150 minutes (before after the ad-libitum lunch meal)
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Blood glucose concentrations will be measured instantly using the glucose oxidase method with an automated glucose analyser
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At 120 minutes and 150 minutes (before after the ad-libitum lunch meal)
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Focus group
Time Frame: Following completion of all beverage trials, an average of 8 weeks
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After all participants have completed their trials, a focus group will be held to gather the children's options on the drinks.
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Following completion of all beverage trials, an average of 8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Catrin Roberts, PhD, Northumbria University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NorthumbriaU(CR/PR)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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