Placebo Effect About Fatigue in Obesity

NCT ID: NCT06299254

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-02-28

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.

Conditions

Obesity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Participants with obesity

Participants affected by obesity (the level of body mass index (BMI) higher or equal to 30).

Placebo-Natural History

Intervention Type: 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.

Healthy-weight participants

As controls, not-hospitalized participants with a healthy weight

Placebo-Natural History

Intervention Type: 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.

Interventions

Placebo-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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: collaborator

Istituto Auxologico Italiano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe

Piancavallo, VCO, Italy

Countries

Italy

Other Identifiers

21C305

Identifier Type: -

Identifier Source: org_study_id