Clinical trial NCT03934580: Postprandial Effects of a Hallucinatory Meal on Appetite Regulation
Official title: Postprandial Effects of a Hallucinatory Meal on Appetite Regulation: a Randomized Cross-over Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Change in Subjective Appetite Score (VAS)
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 8
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Changes in subjective appetite score (VAS)
timeFrame: 270 minutes
Secondary outcomes:
measure: Changes in circulating concentrations of PYY
timeFrame: 180 minutes
measure: Changes in circulating concentrations of GLP-1
timeFrame: 180 minutes
measure: Changes in circulating concentrations of ghrelin
timeFrame: 180 minutes
measure: Changes in circulating concentrations of NPY
timeFrame: 180 minutes
measure: Changes in circulating concentrations of orexin-A
timeFrame: 180 minutes
measure: Changes in circulating concentrations of leptin
timeFrame: 180 minutes
measure: Changes in circulating concentrations of alpha-MSH
timeFrame: 180 minutes
Other outcomes:
Locations:
city: Turin
country: Italy
facility: University of Turin
state: AT
Study officials:
References:
citation: 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.