Postprandial Effects of a Hallucinatory Meal on Appetite Regulation

Sponsor
University of Turin, Italy (Other)
Overall Status
Completed
CT.gov ID
NCT03934580
Collaborator
(none)
8
1
2
16.9
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: hallucinated meal
  • Other: Real meal
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Postprandial Effects of a Hallucinatory Meal on Appetite Regulation: a Randomized Cross-over Pilot Trial
Actual Study Start Date :
Oct 1, 2017
Actual Primary Completion Date :
Dec 30, 2017
Actual Study Completion Date :
Feb 28, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Changes in subjective appetite score (VAS) [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

Secondary Outcome Measures

  1. Changes in circulating concentrations of PYY [180 minutes]

    changes in circulating concentrations of PYY after the hallucinated meal compared to the changes after the real meal

  2. Changes in circulating concentrations of GLP-1 [180 minutes]

    changes in circulating concentrations of GLP-1 after the hallucinated meal compared to the changes after the real meal

  3. Changes in circulating concentrations of ghrelin [180 minutes]

    changes in circulating concentrations of ghrelin after the hallucinated meal compared to the changes after the real meal

  4. Changes in circulating concentrations of NPY [180 minutes]

    changes in circulating concentrations of NPY after the hallucinated meal compared to the changes after the real meal

  5. Changes in circulating concentrations of orexin-A [180 minutes]

    changes in circulating concentrations of orexin-A after the hallucinated meal compared to the changes after the real meal

  6. Changes in circulating concentrations of leptin [180 minutes]

    changes in circulating concentrations of leptin after the hallucinated meal compared to the changes after the real meal

  7. Changes in circulating concentrations of alpha-MSH [180 minutes]

    changes in circulating concentrations of alpha-MSH after the hallucinated meal compared to the changes after the real meal

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Turin Turin AT Italy 10126

Sponsors and Collaborators

  • University of Turin, Italy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Simona Bo, Associate Professor, University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT03934580
Other Study ID Numbers:
  • 183121
First Posted:
May 2, 2019
Last Update Posted:
May 2, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 2, 2019