Influence of Beverage Choice on Hydration Status Cognition and Learning in Children

Not Applicable

Completed

• Conditions: Dehydration in Children; Thirst; Beverage Hydration Index

• Registration Number: NCT06711926
• Lead Sponsor: Northumbria University

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-21
• Study Start: 2024-11-26
• Study First Submitted QC: 2024-11-27
• Study First Posted: 2024-12-02
• Primary Completion: 2024-12-17
• Study Completion: 2024-12-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Beverage hydration index	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 Outcome Measures

Name	Time	Method
Net Fluid Balance	120 minutes after beverage consumption	Net Fluid balance will be calculated subtracting total urine collected from total
Urine Osmolality	120 minutes after beverage consumption	Urine Osmolality will be measured in milliosmoles per kilogram of water.
Serum osmolality	-30 minutes (before beverage consumption)	Serum Osmolality will be measured in milliosmoles per kilogram of water.
Serum Osmolality	120 minutes after beverage consumption	Serum Osmolality will be measured in milliosmoles per kilogram of water.
Gastric emptying rate	-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).
Cognitive function	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)
Neuroimaging	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.
Subjective mood and appetite	-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.
Subjective beverage acceptability	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.
Ad libitum meal	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.
GLP-1 responses to the beverages	-30 minutes (before beverage consumption), 0, 30, 60, 120 minutes (after beverage consumption) and again at 150 minutes (after the ad-libitum lunch meal)	GLP-1 is an intestinal hormone secreted in response to nutrients.
Blood glucose	At 120 minutes and 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
Focus group	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.

Trial Locations

Locations (1)

Northumbria University; 🇬🇧 Newcastle Upon Tyne, United Kingdom