"How Awareness and Subjectivity Modulate the Placebo Effect" (AS-m-P)

Evaluating the Impact of Perceived Control on Placebo Effectiveness: A Comparison Between Classic and Self-Administered Placebo Paradigms

This study consists of a three-group experimental design (active placebo, passive placebo, control) with the primary outcome being perceived fatigue during a cycle ergometer training session. A pre-intervention assessment is planned, in which participants complete (online, via Qualtrics) the Borg Rating of Perceived Exertion (Borg CR10 Scale) and the Positive and Negative Affect Schedule (PANAS; scale for assessing positive and negative emotions). During the intervention, which consists of a cycle ergometer session with 10 minutes of warm-up and 10 minutes of more intense activity, participants will wear a heart rate monitor (Garmin HRM-Pro) to record heart rate and respiratory rate. In addition to these outcomes, distance traveled and speed achieved, extracted from the cycle ergometer data, will also be considered. At the end of the session, the pre-intervention assessment (Borg CR10 and PANAS) will be repeated, and a perceived control scale (Locus of Control of Behaviour) will also be administered.

Study Overview

• Status: Recruiting
• Conditions: 3 Placebo Groups in a Cycle Ergometer Session With Healthy Participants
• Intervention / Treatment: Other: Neutral ginger-flavored drink described as energizing, hypoglycemic, caffeine-based drink; Other: Neutral ginger-flavored drink; Other: Neutral ginger-flavored drink

Detailed Description

The experimental phase of the study will take place at the gym of the IRCCS Fondazione Don Gnocchi. Participants will be invited to attend without having consumed caffeine or alcohol in the previous 6 hours and will be informed that the study consists of a session on the cycle ergometer (hence, they will be asked to wear appropriate clothing).

Through an anonymous link on Qualtrics, participants will initially complete a scale of perceived exertion (Borg Rating of Perceived Exertion) and the PANAS. They will be provided with a chest strap (Garmin HRM-Pro) to monitor heart rate and respiratory rate (the strap will be washed and disinfected after each session), connected to a device capable of reading the data (Garmin Forerunner 245).

Subsequently, each participant will perform a first session, consisting of a 10-minute warm-up (a cadence of 70-80 RPM will be requested). At the end of this first session, in all three conditions, participants will be asked to perform a modified 10-minute maximal test using a classic protocol. Participants will be asked to pedal "with full force" for 10 minutes. During the test, no visual or verbal feedback will be provided. Participants will be blind to the cycle ergometer screen, so the data will not influence their behavior. Respiratory physiological measures and heart rate will be continuously recorded throughout the exercise period and during the participant's recovery. Although the test condition is identical across the three groups, they differ in the type of manipulation they will receive:

Active placebo group. Following the 10-minute warm-up, participants will be presented with a hypoglycemic energy drink (actually a ginger-flavored drink) to be consumed as needed, explicitly stating, "You have at your disposal 10 ml of this particularly energizing, hypoglycemic, caffeine-based drink, designed to reduce fatigue and improve performance. You can decide when it is time to consume it." The researcher will note the moment of consumption.

Passive placebo group. Following the 10-minute warm-up, participants will be presented with a hypoglycemic energy drink (actually a ginger-flavored drink) to be consumed as needed, explicitly stating, "Before continuing, consume this particularly energizing, hypoglycemic, caffeine-based drink, designed to reduce fatigue and improve performance."

Control group. Following the 10-minute warm-up, participants will be presented with a mineral-based drink (actually a ginger-flavored drink), described as such ("Before continuing, consume this mineral-based drink"), which the participant will consume before proceeding with the proposed exercise.

At the end of the exercise, the pre-intervention assessment (Borg CR10 and PANAS) will be repeated, and a perceived control scale (Locus of Control of Behaviour) will also be administered. Upon completion, a debriefing will be provided with an overall explanation of the theory and expected results. Along with the final debriefing, which reveals the deception used (the drink has no actual fatigue-reducing properties), participants will be asked to re-sign the informed consent form.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20148
    • Recruiting
    • Don Gnocchi Foundation
    • Contact: Eleonora Volpato; Phone Number: 3293782692; Email: eleonora.volpato@unicatt.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• People who have a sports medical certificate
• People who speak Italian
• People who give their informed consent

Exclusion Criteria:

• People who do not have a sports medical certificate
• People who do not speak Italian
• People who do not give their informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Placebo; Following the 10-minute warm-up, participants will be presented with a hypoglycemic energy drink (actually a ginger-flavored beverage) to be taken as needed, explicitly stating, "You have 10 ml of this particularly energizing, hypoglycemic, caffeine-based drink, which is designed to reduce fatigue and improve performance. You can decide when to take it." The researcher will note the time of consumption.	Other: Neutral ginger-flavored drink described as energizing, hypoglycemic, caffeine-based drink; It is a neutral ginger-flavored drink with no energizing properties, although it was presented as "particularly energizing, hypoglycemic, caffeine-based, and designed to reduce fatigue and improve performance.; Other Names: Active Placebo
Active Comparator: Passive Placebo; Following the 10-minute warm-up, they will be presented with a hypoglycemic energy drink (actually a ginger-flavored beverage) to be taken as needed, explicitly stating, "Before proceeding, consume this particularly energizing, hypoglycemic, caffeine-based drink, which is designed to reduce fatigue and improve performance."	Other: Neutral ginger-flavored drink; A neutral ginger flavoured drink described as an energizing, hypoglycemic, caffeine-based drink, which is designed to reduce fatigue and improve performance.; Other Names: Passive Placebo; Other: Neutral ginger-flavored drink; A neutral ginger-flavored beverage bescribed as a mineral salt-based drink; Other Names: Control
Sham Comparator: Control; Following the 10-minute warm-up, they will be presented with a mineral salt-based drink (actually a ginger-flavored beverage), described as such ("Before proceeding, consume this mineral salt-based drink"), which the participant will consume before continuing with the proposed exercise.	Other: Neutral ginger-flavored drink; A neutral ginger flavoured drink described as an energizing, hypoglycemic, caffeine-based drink, which is designed to reduce fatigue and improve performance.; Other Names: Passive Placebo; Other: Neutral ginger-flavored drink; A neutral ginger-flavored beverage bescribed as a mineral salt-based drink; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Borg Rating of Perceived Exertion	The Borg Rating of Perceived Exertion (RPE) scale is a subjective tool used to measure the perceived intensity of physical effort, fatigue and exertion during exercise. The scale ranges from 6 to 20, where 6 represents minimal effort (such as sitting) and 20 represents the maximal possible effort.	2 hours
Positive and Negative Affect Schedule	The Positive and Negative Affect Schedule (PANAS) is a psychological tool developed by Watson, Clark, and Tellegen in 1988, designed to measure positive and negative affect. It comprises 20 items, with 10 items each for positive affect (PA) and negative affect (NA). The PA scale assesses the extent to which an individual feels enthusiastic, active, and alert, while the NA scale measures the degree of distress and aversive emotional states such as anger, guilt, and fear. Participants rate each emotion on a 1 to 5 scale, indicating the extent to which they have experienced these feelings over a specified time frame. High PA scores reflect elevated positive emotions, whereas high NA scores indicate elevated negative emotions.	2 hours
Socio-demographic variables	Gender, age, smoking status, and number of cigarettes smoked per day. Additionally, factors such as alcohol use (frequency), physical activity (frequency and type), level of education, marital status.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance traveled	kilometers per hour	2 hours

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus

Publications and helpful links

General Publications

• Pires FO, Dos Anjos CAS, Covolan RJM, Fontes EB, Noakes TD, St Clair Gibson A, Magalhaes FH, Ugrinowitsch C. Caffeine and Placebo Improved Maximal Exercise Performance Despite Unchanged Motor Cortex Activation and Greater Prefrontal Cortex Deoxygenation. Front Physiol. 2018 Aug 17;9:1144. doi: 10.3389/fphys.2018.01144. eCollection 2018.
• Craig AR, Franklin JA, Andrews G. A scale to measure locus of control of behaviour. Br J Med Psychol. 1984 Jun;57 ( Pt 2):173-80. doi: 10.1111/j.2044-8341.1984.tb01597.x.
• Friston K. The free-energy principle: a unified brain theory? Nat Rev Neurosci. 2010 Feb;11(2):127-38. doi: 10.1038/nrn2787. Epub 2010 Jan 13.
• Geers AL, Helfer SG, Weiland PE, Kosbab K. Expectations and placebo response: a laboratory investigation into the role of somatic focus. J Behav Med. 2006 Apr;29(2):171-8. doi: 10.1007/s10865-005-9040-5. Epub 2005 Dec 23.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: November 10, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Placebo; Self-Efficacy; Agency
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neurotransmitter Agents; Purinergic Antagonists; Purinergic Agents; Central Nervous System Stimulants; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Caffeine; Hypoglycemic Agents
• Other Study ID Numbers: UCSC_21102022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No