Postprandial Effects of a Hallucinatory Meal on Appetite Regulation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Postprandial Effects of a Hallucinatory Meal on Appetite Regulation: a Randomized Cross-over Pilot Trial

Conditions
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Change in Subjective Appetite Score (VAS)

Intervention / Treatment
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* Other: hallucinated meal
* Other: Real meal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female gender, ability to develop a visual hallucination during hypnosis, body mass index (BMI) range 20-27 kg/m2, menopausal status Exclusion Criteria: smoking, 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hallucinated meal<br>A breakfast meal (white bread plus ham and cheese with 250 ml still water) is hallucinated under hypnosis by participants for 15 minutes | Other: hallucinated meal<br>* a breakfast meal (white bread plus ham and cheese with 250 ml still water) is hallucinated by participants under hypnosis<br>|
| Active Comparator: real meal<br>A real meal (white bread plus ham and cheese with 250 ml still water) is consumed by participants in 15 minutes | Other: Real meal<br>* A real breakfast (white bread plus ham and cheese with 250 ml still water) is consumed by participants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in subjective appetite score (VAS) | 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 | 270 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in circulating concentrations of PYY | changes in circulating concentrations of PYY after the hallucinated meal compared to the changes after the real meal | 180 minutes | 
| Changes in circulating concentrations of GLP-1 | changes in circulating concentrations of GLP-1 after the hallucinated meal compared to the changes after the real meal | 180 minutes | 
| Changes in circulating concentrations of ghrelin | changes in circulating concentrations of ghrelin after the hallucinated meal compared to the changes after the real meal | 180 minutes | 
| Changes in circulating concentrations of NPY | changes in circulating concentrations of NPY after the hallucinated meal compared to the changes after the real meal | 180 minutes | 
| Changes in circulating concentrations of orexin-A | changes in circulating concentrations of orexin-A after the hallucinated meal compared to the changes after the real meal | 180 minutes | 
| Changes in circulating concentrations of leptin | changes in circulating concentrations of leptin after the hallucinated meal compared to the changes after the real meal | 180 minutes | 
| Changes in circulating concentrations of alpha-MSH | changes in circulating concentrations of alpha-MSH after the hallucinated meal compared to the changes after the real meal | 180 minutes |