NCT06967454已完成不适用
Manipulation of Whey Permeate Formulation for Better Fluid Retention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Beverage Hydration Index
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Test beverages were presented to the participant in a dark bottle, and were not told which beverage they were consuming for each trial.
入排标准
- 年龄范围
- 9 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 9-11
排除标准
- •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
结局指标
主要结局
Beverage Hydration Index
时间窗: 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.
次要结局
- Net Fluid Balance(120 minutes after beverage consumption)
- Urine Osmolality(120 minutes after beverage consumption)
- Serum Osmolality(120 minutes after beverage consumption)
- Gastric emptying rate(-30 minutes (before beverage), 15, 30, 45, 60, 75, 90, 105, 120 minutes (after beverage consumption))
- Cognitive function(105 minutes (after beverage consumption))
- Neuroimaging(105 minutes (after beverage consumption))
- Subjective mood and appetite(-30 minutes (before beverage consumption), 0, 45, 105, 120 and 150minutes (after beverage consumption))
- Subjective beverage acceptability(0 minutes (immediately after beverage consumption))
- Ad libitum pasta meal(120-150 minutes (after beverage consumption))
- Blood glucose(At -30, 0, 60, 120, 150 minutes (before after the ad-libitum lunch meal))
- Focus group(Following completion of all beverage trials, an average of 8 weeks)
研究者
Catrin Roberts
Principle investigator
Northumbria University
研究点 (1)
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