ObesityPOFNCT06299254
Placebo Effect About Fatigue in Obesity
An observational study of Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
Fatigue is a central symptom of obesity: it significantly impacts daily functioning, psychological well-being, compliance with physical therapy, and quality of life. However, the full understanding of the origin and treatment of fatigue in obesity is still a matter of debate, requiring further research, especially… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2023to 28 Feb 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants with obesity will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). Controls will be recruited out of the hospital
Who may be able to join
- Right-handed diagnosis of obesity (the level of body mass index - BMI - higher or equal to 30).
Who cannot join
- concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe
Piancavallo, VCO, 28824
About this study
Official title: The Modulation of Individual Level of Fatigue Through Placebo Effect in Obesity
Fatigue is a central symptom of obesity: it significantly impacts daily functioning, psychological well-being, compliance with physical therapy, and quality of life. However, the full understanding of the origin and treatment of fatigue in obesity is still a matter of debate, requiring further research, especially from new perspectives. From a neuroscientific perspective, fatigue is more than the subjective perception of tiredness resulting from mental or physical exertion or illness. It results in the complex interaction between (bottom-up) sensory input coming from the periphery, and motivational and psychological input, which is related to top-down cognition. In this framework, placebos may affect the output of the top-down cognitive processing by altering the individual evaluation of the ongoing peripheral performance. Indeed, evidence from both healthy conditions and clinical contexts suggests that fatigue can be modulated. The after-effect of such a modulation can be observed not only at a behavioural level, in terms of physical endurance, but also a psychological (i.e., decreased of perceived fatigue) and neurophysiological (changes in brain activity, especially in the fatigue-related components as the RP) levels.
- Conditions
- Obesity
- Being tested
- Placebo-Natural History
- Keywords
- placebo effect, fatigue, motivation, physical abilities
- Medical subject headings
- Obesity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo-Natural HistoryOther
Half of the participants will receive a placebo (i.e., motivational/verbal) cue before and after an experimental session in which they will perform several lifts.
Half of the participants will receive no placebo before and after an experimental session in which they will perform several lifts.
| Study group | Role | What they receive |
|---|---|---|
| Participants with obesity | Participants affected by obesity (the level of body mass index (BMI) higher or equal to 30). Receives: Other: Placebo-Natural History | |
| Healthy-weight participants | As controls, not-hospitalized participants with a healthy weight Receives: Other: Placebo-Natural History |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioural outcome of fatigue
The number of flexions (from a minimum of 0 to maximum of180) performed before and after the treatment for each individual.
Measured: baseline
Secondary outcomes (1)
The individual level of perceived fatigue
On a Likert scale (from 0 to 7), participants verbally report the individual level of perceived fatigue in doing the flexions before and after the treatment.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Mar 2023
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turin, Italy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299254
- Sponsor's protocol ID
- 21C305
- Acronym
- POF
- Status last verified
- Aug 2025
- First submitted
- 28 Feb 2024
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Modulation of Individual Level of Fatigue Through Placebo Effect in Obesity
- ClinicalTrials.gov ID
- NCT06299254
- Acronym / sponsor ID
- POF / 21C305
- Conditions
- Obesity
- Keywords
- placebo effect, fatigue, motivation, physical abilities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Collaborators
- University of Turin, Italy
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 7 Mar 2024 (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.
Fatigue is a central symptom of obesity: it significantly impacts daily functioning, psychological well-being, compliance with physical therapy, and quality of life. However, the full understanding of the origin and treatment of fatigue in obesity is still a matter of debate, requiring further research, especially from new perspectives. From a neuroscientific perspective, fatigue is more than the subjective perception of tiredness resulting from mental or physical exertion or illness. It results in the complex interaction between (bottom-up) sensory input coming from the periphery, and motivational and psychological input, which is related to top-down cognition. In this framework, placebos may affect the output of the top-down cognitive processing by altering the individual evaluation of the ongoing peripheral performance. Indeed, evidence from both healthy conditions and clinical contexts suggests that fatigue can be modulated. The after-effect of such a modulation can be observed not only at a behavioural level, in terms of physical endurance, but also a psychological (i.e., decreased of perceived fatigue) and neurophysiological (changes in brain activity, especially in the fatigue-related components as the RP) levels.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with obesity | – | Other: Placebo-Natural HistoryParticipants affected by obesity (the level of body mass index (BMI) higher or equal to 30). |
| Healthy-weight participants | – | Other: Placebo-Natural HistoryAs controls, not-hospitalized participants with a healthy weight |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants with obesity will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). Controls will be recruited out of the hospital
Key inclusion criteria (1 listed)
- Right-handed diagnosis of obesity (the level of body mass index - BMI - higher or equal to 30).
Key exclusion criteria (1 listed)
- concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric 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 |
|---|---|---|
| Placebo-Natural HistoryHalf of the participants will receive a placebo (i.e., motivational/verbal) cue before and after an experimental session in which they will perform several lifts. Half of the participants will receive no placebo before and after an experimental session in which they will perform several lifts. | Other | Healthy-weight participants, Participants with obesity |
Primary outcome
Behavioural outcome of fatigue
Time frame: baseline
The number of flexions (from a minimum of 0 to maximum of180) performed before and after the treatment for each individual.
1 secondary outcome
The individual level of perceived fatigue
Time frame: baseline
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 27 Aug 2025.
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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?
An observational study of Obesity, run by Istituto Auxologico Italiano 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 1 inclusion and 1 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 27 Aug 2025. 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?
Behavioural outcome of fatigue (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2025.