Postprandial Effects of a Hallucinatory Meal on Appetite Regulation

Change in Subjective Appetite Score (VAS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934580
• Other study ID #: 183121
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: April 2019
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 28, 2019
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Change in Subjective Appetite Score (VAS)

Intervention

Other:
• hallucinated meal
a breakfast meal (white bread plus ham and cheese with 250 ml still water) is hallucinated by participants under hypnosis
• Real meal
A real breakfast (white bread plus ham and cheese with 250 ml still water) is consumed by participants

Locations

Country	Name	City	State
Italy	University of Turin	Turin	AT

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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