Postprandial Effects of a Hallucinatory Meal on Appetite Regulation: a Randomized Cross-over Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Changes in subjective appetite score (VAS)
研究概览
简要总结
Several and complex mechanisms are involved in the regulation of appetite and food intake in humans. By means of rapid hypnosis techniques, it is possible to induce some individuals to hallucinate a meal.
The same meal (breakfast) is administered as i) a real meal and ii) is evoked as a hallucination under hypnosis in healthy postmenopausal women. The aim of this pilot randomized-controlled cross-over trial is to assess appetite sensation and the blood levels of the appetite-related hormones in the participants.
详细描述
The regulation of appetite is crucial to control food intake and consequently body weight. Hypnosis has been successfully used to modulate gastrointestinal functions, by imagining eating food.
In the present pilot trial, the investigators search to investigate the effects a hallucinatory meal by hypnosis on subjective appetite and appetite hormone blood levels. Hence, two different breakfast meals are randomly administered to eight healthy postmenopausal women, in a crossover design, consisting of i) a hallucinatory breakfast meal (HB) and ii) a real breakfast meal (RB). On each test day, participants undergo baseline measurements, including appetite sensation and blood sample, then the test meal is hallucinated or served. Subjective appetite is assessed each 30 minutes for 4 hours and half, while blood samples are taken at 20', 60', 90' and 180 minutes. At the end of each session, participants are instructed to fill in a food record for the following 3-days.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female gender,
- •ability to develop a visual hallucination during hypnosis,
- •body mass index (BMI) range 20-27 kg/m2,
- •menopausal status
排除标准
- •breakfast skipping,
- •current intake of any supplements,
- •current use of any drug,
- •presence of any pathological conditions, including mental and eating disorders,
- •any alimentary restrictions or specific diets,
- •allergies or food intolerances or dislikes of the offered breakfast-meal,
- •being a shift or night workers,
- •unable to give a written informed consent
研究组 & 干预措施
hallucinated meal
A breakfast meal (white bread plus ham and cheese with 250 ml still water) is hallucinated under hypnosis by participants for 15 minutes
干预措施: hallucinated meal (Other)
real meal
A real meal (white bread plus ham and cheese with 250 ml still water) is consumed by participants in 15 minutes
干预措施: Real meal (Other)
结局指标
主要结局
Changes in subjective appetite score (VAS)
时间窗: 270 minutes
changes in subjective appetite score as measured by VAS after the hallucinated meal compared to the changes in subjective appetite score after the real meal
次要结局
- Changes in circulating concentrations of PYY(180 minutes)
- Changes in circulating concentrations of GLP-1(180 minutes)
- Changes in circulating concentrations of ghrelin(180 minutes)
- Changes in circulating concentrations of NPY(180 minutes)
- Changes in circulating concentrations of orexin-A(180 minutes)
- Changes in circulating concentrations of leptin(180 minutes)
- Changes in circulating concentrations of alpha-MSH(180 minutes)
研究者
Simona Bo
Associate Professor
University of Turin, Italy