Comparison of the Satiety Effect of a Very Low Energy Foam With Normal Energy Foams
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 主要终点
- Hunger and satiety questions
研究概览
简要总结
To compare, in a randomized, single-blinded, cross-over study the satiety effect of a very low energy aerated beverage with normal energy aerated beverages in healthy subjects.
详细描述
The primary objective of this study is to assess if a very low energy foam has the same effect on satiety as the same volume of a reference normal energy foam, by testing for equivalence of these two foams. Treatment equivalence, is met if the 90% confidence interval (CI) of between-treatment differences in appetite AUC is within the range of -5 to +5 mm/min of the reference . Two other normal energy foams with slightly different compositions are also compared to the reference foam to test for possible effects of differences in composition (carbohydrate type, emulsifier) other than energy per se.
On each test day, volunteers will arrive at the clinic in a fasted state where they consume a standardized 250 kcal breakfast. Subjects receive one of the four test products 2.5 hours after start of breakfast and consume 400 ml of the test products with a spoon within 10 minutes. Each subject will be randomized to a treatment order according to a balanced (Williams type) design, and receive one of four test products each week for 4 weeks, separated by a one-week washout period (consumed on the same week day).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 20 and 30 kg/m² (inclusive)
- •Apparently healthy: no medical conditions which might effect study measurements (judged by study physician).
排除标准
- •Dislike, allergy or intolerance to test products
- •Eating disorder (measured by SCOFF questionnaire, > 2 "yes" responses)
- •High or very high restrained eater measured by Three factor eating questionnaire TFEQ, restriction score > 14
- •Reported medical treatment that may affect eating habits/satiety
研究组 & 干预措施
Very low energy aerated beverage
Very low energy aerated beverage
干预措施: Very low energy aerated beverage (Dietary Supplement)
Normal energy aerated beverage 1
Normal energy aerated beverage 1
干预措施: Normal energy aerated beverage 1 (Dietary Supplement)
Normal energy aerated beverage 2
Normal energy aerated beverage 2
干预措施: Normal energy aerated beverage 2 (Dietary Supplement)
Normal energy aerated beverage 3
Normal energy aerated beverage 3
干预措施: Normal energy aerated beverage 3 (Dietary Supplement)
结局指标
主要结局
Hunger and satiety questions
时间窗: Time points -155, -90, -5, 15, 30, 60, 90, 120, 150 and 180 min
Area under the time curve of hunger and satiety scores (as rated by the subjects on a Visual Analog Scale)
次要结局
- Electronic Visual Analogue Scale (EVAS) for liking questions(Time point 15 min)
