Skip to main content
OpenTrials
Completed

NCT Number: NCT06299254

Placebo Effect About Fatigue 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe

Piancavallo, VCO, 28824, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo-Natural History

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. The individual level of perceived fatigue

    Time frame: baseline

    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.

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Collaborators

  • University of Turin, Italy

Registry information

Official study title

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

Acronym: POF

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 7, 2024
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.