Change in Subjective Appetite Score (VAS)NCT03934580
Postprandial Effects of a Hallucinatory Meal on Appetite Regulation
A study testing hallucinated meal and Real meal in people with Change in Subjective Appetite Score (VAS), run by University of Turin, Italy at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Change in Subjective Appetite Score (VAS)
- What is being tested?
- hallucinated meal and Real meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2017to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female gender,
- ability to develop a visual hallucination during hypnosis,
- body mass index (BMI) range 20-27 kg/m2,
- menopausal status
Who cannot join
- 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,
Show all 9Show fewer
- allergies or food intolerances or dislikes of the offered breakfast-meal,
- being a shift or night workers,
- unable to give a written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- hallucinated meal, Real meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hallucinated mealOther
a breakfast meal (white bread plus ham and cheese with 250 ml still water) is hallucinated by participants under hypnosis
Real mealOther
A real breakfast (white bread plus ham and cheese with 250 ml still water) is consumed by participants
| Study group | Role | What they receive |
|---|---|---|
| hallucinated meal | Experimental | A breakfast meal (white bread plus ham and cheese with 250 ml still water) is hallucinated under hypnosis by participants for 15 minutes Receives: Other: hallucinated meal |
| real meal | Active comparator | A real meal (white bread plus ham and cheese with 250 ml still water) is consumed by participants in 15 minutes Receives: Other: Real meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 270 minutes
Secondary outcomes (7)
Changes in circulating concentrations of PYY
changes in circulating concentrations of PYY after the hallucinated meal compared to the changes after the real meal
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start1 Oct 2017
- Primary completion30 Dec 2017
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Change in Subjective Appetite Score (VAS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simona Bo, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934580
- Sponsor's protocol ID
- 183121
- Status last verified
- Apr 2019
- First submitted
- 23 Apr 2019
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32418064
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Effects of a Hallucinatory Meal on Appetite Regulation: a Randomized Cross-over Pilot Trial
- ClinicalTrials.gov ID
- NCT03934580
- Acronym / sponsor ID
- 183121
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hallucinated meal | Experimental | Other: hallucinated mealA breakfast meal (white bread plus ham and cheese with 250 ml still water) is hallucinated under hypnosis by participants for 15 minutes |
| real meal | Active comparator | Other: Real mealA real meal (white bread plus ham and cheese with 250 ml still water) is consumed by participants in 15 minutes |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- female gender,
- ability to develop a visual hallucination during hypnosis,
- body mass index (BMI) range 20-27 kg/m2,
- menopausal status
Key exclusion criteria (9 listed)
- smoking,
- breakfast skipping,
- current intake of any supplements,
- current use of any drug,
- presence of any pathological conditions, including mental and eating disorders,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hallucinated meala breakfast meal (white bread plus ham and cheese with 250 ml still water) is hallucinated by participants under hypnosis | Other | hallucinated meal |
| Real mealA real breakfast (white bread plus ham and cheese with 250 ml still water) is consumed by participants | Other | real meal |
Primary outcome
Changes in subjective appetite score (VAS)
Time frame: 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
7 secondary outcomes
Changes in circulating concentrations of PYY
Time frame: 180 minutes
Changes in circulating concentrations of GLP-1
Time frame: 180 minutes
Changes in circulating concentrations of ghrelin
Time frame: 180 minutes
Changes in circulating concentrations of NPY
Time frame: 180 minutes
Changes in circulating concentrations of orexin-A
Time frame: 180 minutes
Changes in circulating concentrations of leptin
Time frame: 180 minutes
Changes in circulating concentrations of alpha-MSH
Time frame: 180 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Derived from this study: PubMed 32418064Cioffi 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hallucinated meal and Real meal in people with Change in Subjective Appetite Score (VAS), run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in subjective appetite score (VAS) (time frame: 270 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03934580, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2019.