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
研究组 & 干预措施
Beverage 2
Strawberry flavoured milk (Semi Skimmed)
干预措施: Semi-skimmed milk (Other)
Beverage 3: Whey permeate
Strawberry flavoured whey permeate
干预措施: Whey permeate (Other)
'Low drinkers' trial
150ml only of the strawberry water
干预措施: 'Low dose' water (Other)
Beverage 1
Strawberry flavoured Water
干预措施: Water (Other)
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.
Beverage Hydration Index
时间窗: 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.
Beverage Hydration Index
时间窗: 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.
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)
- Urine Osmolality(60 minutes after beverage consumption)
- Net Fluid Balance(0 minutes after beverage consumption)
- Net Fluid Balance(60 minutes after beverage consumption)
- Urine Osmolality(-30 minutes before beverage consumption)
- Urine Osmolality(0 minutes after beverage consumption)
- Serum Osmolality(-30 minutes (before beverage consumption))
- Serum Osmolality(0 minutes after beverage consumption)
- Serum Osmolality(30 minutes after beverage consumption)
- Serum Osmolality(60 minutes after beverage consumption)
- Cognitive function(-45 minutes (before beverage consumption))
- Cognitive function(45 minutes (after beverage consumption))
- Neuroimaging(-45 minutes (before beverage consumption))
- Neuroimaging(45 minutes (after beverage consumption))
研究者
Catrin Roberts
Principle investigator
Northumbria University