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| Name | Class |
|---|---|
| University of Surrey | OTHER |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Beverage 1 | Experimental | Distilled water |
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| Experimental: Beverage 2 | Experimental | Semi skimmed milk |
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| Experimental: Beverage 3 | Experimental | Whey permeate |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Distilled water | Other | 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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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Net Fluid Balance | Net Fluid balance will be calculated subtracting total urine collected from total liquid consumed | 0 minutes after beverage consumption |
| Net Fluid Balance | Net Fluid balance will be calculated subtracting total urine collected from total |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catrin Roberts, PhD | Northumbria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northumbria University | Newcastle upon Tyne | United Kingdom |
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| ID | Term |
|---|---|
| D018752 | Diet, Fat-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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Randomised, crossover study.
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Test beverages were presented to the participant in a dark bottle, and were not told which beverage they were consuming for each trial.
| Semi-skimmed milk | Other | 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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| Whey permeate | Other | 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). |
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| 60 minutes after beverage consumption |
| Net Fluid Balance | Net Fluid balance will be calculated subtracting total urine collected from total | 120 minutes after beverage consumption |
| Urine Osmolality | Urine Osmolality will be measured in milliosmoles per kilogram of water. | -30 minutes before beverage consumption |
| Urine Osmolality | Urine Osmolality will be measured in milliosmoles per kilogram of water. | 0 minutes after beverage consumption |
| Urine Osmolality | Urine Osmolality will be measured in milliosmoles per kilogram of water. | 60 minutes after beverage consumption |
| Urine Osmolality | Urine Osmolality will be measured in milliosmoles per kilogram of water. | 120 minutes after beverage consumption |
| Serum osmolality | Serum Osmolality will be measured in milliosmoles per kilogram of water. | -30 minutes (before beverage consumption) |
| Serum Osmolality | Serum Osmolality will be measured in milliosmoles per kilogram of water. | 0 minutes after beverage consumption |
| Serum Osmolality | Serum Osmolality will be measured in milliosmoles per kilogram of water. | 30 minutes after beverage consumption |
| Serum Osmolality | Serum Osmolality will be measured in milliosmoles per kilogram of water. | 60 minutes after beverage consumption |
| Serum Osmolality | Serum Osmolality will be measured in milliosmoles per kilogram of water. | 120 minutes after beverage consumption |
| Gastric emptying rate | 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). | -30 minutes (before beverage), 15, 30, 45, 60, 75, 90, 105, 120 minutes (after beverage consumption). |
| Cognitive function | 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 (before beverage consumption) |
| Cognitive function | 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) |
| Cognitive function | 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) | 105 minutes (after beverage consumption) |
| Neuroimaging | 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 (before beverage consumption) |
| Neuroimaging | 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 | 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 | 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. | -30 minutes (before beverage consumption), 0, 45, 105, 120 and 150minutes (after beverage consumption) |
| Subjective beverage acceptability | 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. | 0 minutes (immediately after beverage consumption) |
| Ad libitum meal | 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. | 120-150 minutes (after beverage consumption) |
| Blood glucose | Blood glucose concentrations will be measured instantly using the glucose oxidase method with an automated glucose analyser | At 120 minutes and 150 minutes (before after the ad-libitum lunch meal) |
| Focus group | After all participants have completed their trials, a focus group will be held to gather the children's options on the drinks. | Following completion of all beverage trials, an average of 8 weeks |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |