Postprandial Effects of a Hallucinatory Meal on Appetite Regulation

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

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.

Study Overview

• Status: Completed
• Conditions: Change in Subjective Appetite Score (VAS)
• Intervention / Treatment: Other: hallucinated meal; Other: Real meal

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • AT
    • Turin, AT, Italy, 10126
      • University of Turin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Publications and helpful links

General Publications

• Cioffi I, Gambino R, Rosato R, Properzi B, Regaldo G, Ponzo V, Pellegrini M, Contaldo F, Pasanisi F, Ghigo E, Bo S. Acute assessment of subjective appetite and implicated hormones after a hypnosis-induced hallucinated meal: a randomized cross-over pilot trial. Rev Endocr Metab Disord. 2020 Sep;21(3):411-420. doi: 10.1007/s11154-020-09559-4.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): December 30, 2017
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (Actual): May 2, 2019

Study Record Updates

• Last Update Posted (Actual): May 2, 2019
• Last Update Submitted That Met QC Criteria: April 30, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 183121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No