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Placebo Effect About Fatigue in Obesity

The Modulation of Individual Level of Fatigue Through Placebo Effect in Obesity

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06299254
Acronym
POF
Enrollment
80
Registered
2024-03-07
Start date
2023-03-01
Completion date
2025-02-28
Last updated
2025-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

placebo effect, fatigue, motivation, physical abilities

Brief 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 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.

Interventions

OTHERPlacebo-Natural History

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.

Sponsors

University of Turin, Italy
CollaboratorOTHER
Istituto Auxologico Italiano
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

• Right-handed diagnosis of obesity (the level of body mass index - BMI - higher or equal to 30).

Exclusion criteria

• concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders

Design outcomes

Primary

MeasureTime frameDescription
Behavioural outcome of fatiguebaselineThe number of flexions (from a minimum of 0 to maximum of180) performed before and after the treatment for each individual.

Secondary

MeasureTime frameDescription
The individual level of perceived fatiguebaselineOn 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026