Postprandial Effects of a Hallucinatory Meal on Appetite Regulation

NCT ID: NCT03934580

Last Updated: 2019-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2019-02-28

Brief 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.

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.

Conditions

Change in Subjective Appetite Score (VAS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

hallucinated meal

Intervention Type: OTHER

a breakfast meal (white bread plus ham and cheese with 250 ml still water) is hallucinated by participants under hypnosis

real meal

A real meal (white bread plus ham and cheese with 250 ml still water) is consumed by participants in 15 minutes

Group Type: ACTIVE_COMPARATOR

Real meal

Intervention Type: OTHER

A real breakfast (white bread plus ham and cheese with 250 ml still water) is consumed by participants

Interventions

hallucinated meal

a breakfast meal (white bread plus ham and cheese with 250 ml still water) is hallucinated by participants under hypnosis

Intervention Type: OTHER

Real meal

A real breakfast (white bread plus ham and cheese with 250 ml still water) is consumed by participants

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Simona Bo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Turin

Turin, AT, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 32418064 (View on PubMed)

Other Identifiers

183121

Identifier Type: -

Identifier Source: org_study_id