Factors That Determine the Responses to Meal Ingestion: Deconditioning of Acquired Food Aversion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Difference in postprandial fullness sensation before and after conditioning
研究概览
简要总结
Background. Aversive conditioning impairs the rewarding value of a comfort meal.
Our aim is to demonstrate the potential effect of deconditioning to reverse aversive conditioning and restore the hedonic postprandial response.
Methods: A sham-controlled, randomised, parallel, single-blind study will be performed on 12 healthy women (6 per group). The rewarding value of a comfort meal will be measured at initial exposure, after aversive conditioning (masked administration of the same meal with a high-fat content) and after a deconditioning intervention (unmasking the aversive conditioning paradigm in the deconditioning group vs sham intervention in the control group). Digestive well-being (primary outcome) will be measured every 10 min before and 60 min after ingestion using graded scales. The effect of deconditioning (change from aversive conditioning to deconditioning) will be compared to sham deconditioning in the control group.
Expected results: The comfort meal at first exposure will induce a pleasant postprandial experience, which will be impaired by aversive conditioning; this effect will be reverted by deconditioning and the hedonic value of the comfort meal will be restored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •non-obese
排除标准
- •history of gastrointestinal symptoms
- •prior obesity
- •use of medications
- •history of anosmia and ageusia
- •current dieting
- •alcohol abuse
- •psychological disorders
- •eating disorders
结局指标
主要结局
Difference in postprandial fullness sensation before and after conditioning
时间窗: 120 minutes
Change in fullness sensation by a 10 cm scale graded from 0 (not at all) to 10 (very much) in response to a probe meal before and after conditioning.
Change in postprandial discomfort before and after conditioning
时间窗: 120 minutes
Change in the sensation of discomfort by a 10 cm scale graded from 0 (not at all) to 10 (very much) in response to a probe meal before and after conditioning
Change in postprandial hunger/satiety before and after conditioning
时间窗: 120 minutes
Change in mood measured by a 10 cm scale graded from -5 (extremely hungry) to +5 (completely satiate) in response to a probe meal before and after conditioning.
Difference in postprandial digestive well-being before and after deconditioning
时间窗: 120 minutes
Change in digestive well-being measured by a 10 cm scale graded from -5 (extremely unpleasant sensation) to +5 (extremely pleasant sensation) in response to a probe meal before and after deconditioning.
Change in postprandial mood before and after conditioning
时间窗: 120 minutes
Change in mood measured by a 10 cm scale graded from -5 (negative) to +5 (positive) in response to a probe meal before and after conditioning.
次要结局
未报告次要终点