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Placebo Effect About Fatigue in Obesity (POF)

I

Istituto Auxologico Italiano

Status

Completed

Conditions

Obesity

Treatments

Other: Placebo-Natural History

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Participants with obesity
Description:
Participants affected by obesity (the level of body mass index (BMI) higher or equal to 30).
Treatment:
Other: Placebo-Natural History
Healthy-weight participants
Description:
As controls, not-hospitalized participants with a healthy weight
Treatment:
Other: Placebo-Natural History

Trial contacts and locations

1

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Central trial contact

Federica Scarpina, PhD; Luca Grappiolo

Data sourced from clinicaltrials.gov

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