3 Placebo Groups in a Cycle Ergometer Session With Healthy ParticipantsAS-m-PNCT06533137
"How Awareness and Subjectivity Modulate the Placebo Effect"
A study testing Neutral ginger-flavored drink described as energizing, hypoglycemic, caffeine-based drink and Neutral ginger-flavored drink in people with 3 Placebo Groups in a Cycle Ergometer Session With Healthy Participants, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- 3 Placebo Groups in a Cycle Ergometer Session With Healthy Participants
- What is being tested?
- Neutral ginger-flavored drink described as energizing, hypoglycemic, caffeine-based drink and Neutral ginger-flavored drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- 28 Nov 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People who have a sports medical certificate
- People who speak Italian
- People who give their informed consent
Who cannot join
- People who do not have a sports medical certificate
- People who do not speak Italian
- People who do not give their informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Don Gnocchi Foundation
Milan, 20148
Eleonora Volpato, 3293782692, eleonora.volpato@unicatt.it
About this study
Official title: 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.
Read the 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.
- Being tested
- Neutral ginger-flavored drink described as energizing, hypoglycemic, caffeine-based drink, Neutral ginger-flavored drink
- Keywords
- Placebo, Agency, Self-Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutral ginger-flavored drink described as energizing, hypoglycemic, caffeine-based drinkOther
Also called Active Placebo
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.
Neutral ginger-flavored drinkOther
Also called Passive Placebo
A neutral ginger flavoured drink described as an energizing, hypoglycemic, caffeine-based drink, which is designed to reduce fatigue and improve performance.
Neutral ginger-flavored drinkOther
Also called Control
A neutral ginger-flavored beverage bescribed as a mineral salt-based drink
| Study group | Role | What they receive |
|---|---|---|
| Active Placebo | Experimental | 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. Receives: Other: Neutral ginger-flavored drink described as energizing, hypoglycemic, caffeine-based drink |
| Passive Placebo | Active comparator | 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." Receives: Other: Neutral ginger-flavored drink |
| Control | Sham comparator | 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. Receives: Other: Neutral ginger-flavored drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 hours
Secondary outcomes (1)
Distance traveled
kilometers per hour
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start28 Nov 2022
- Primary completion1 Dec 2022
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 3 Placebo Groups in a Cycle Ergometer Session With Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleonora Volpato, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533137
- Sponsor's protocol ID
- UCSC_21102022
- Acronym
- AS-m-P
- Status last verified
- Nov 2024
- First submitted
- 23 Jul 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30246799Craig AR, Franklin JA, Andrews G. A scale to measure locus of control of behaviour. Br J Med Psychol. 1984 Jun;57(2):173-80. doi: 10.1111/j.2044-8341.1984.tb01597.x.
PubMed 6743598Friston 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.
PubMed 20068583Geers 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.
PubMed 16374671
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Perceived Control on Placebo Effectiveness: A Comparison Between Classic and Self-Administered Placebo Paradigms
- ClinicalTrials.gov ID
- NCT06533137
- Acronym / sponsor ID
- AS-m-P / UCSC_21102022
- Keywords
- Placebo, Agency, Self-Efficacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Placebo | Experimental | Other: Neutral ginger-flavored drink described as energizing, hypoglycemic, caffeine-based drinkFollowing 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. |
| Passive Placebo | Active comparator | Other: Neutral ginger-flavored drinkFollowing 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." |
| Control | Sham comparator | Other: Neutral ginger-flavored drinkFollowing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- People who have a sports medical certificate
- People who speak Italian
- People who give their informed consent
Key exclusion criteria (3 listed)
- People who do not have a sports medical certificate
- People who do not speak Italian
- People who do not give their informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neutral ginger-flavored drink described as energizing, hypoglycemic, caffeine-based drinkAlso: Active PlaceboIt 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 | Active Placebo |
| Neutral ginger-flavored drinkAlso: Passive PlaceboA neutral ginger flavoured drink described as an energizing, hypoglycemic, caffeine-based drink, which is designed to reduce fatigue and improve performance. | Other | Passive Placebo |
| Neutral ginger-flavored drinkAlso: ControlA neutral ginger-flavored beverage bescribed as a mineral salt-based drink | Other | Control |
Primary outcome
Borg Rating of Perceived Exertion
Time frame: 2 hours
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.
Positive and Negative Affect Schedule
Time frame: 2 hours
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.
Socio-demographic variables
Time frame: 2 hours
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.
1 secondary outcome
Distance traveled
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Results publication: PubMed 30246799Pires 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.
- Results publication: PubMed 6743598Craig AR, Franklin JA, Andrews G. A scale to measure locus of control of behaviour. Br J Med Psychol. 1984 Jun;57(2):173-80. doi: 10.1111/j.2044-8341.1984.tb01597.x.
- Results publication: PubMed 20068583Friston 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.
- Results publication: PubMed 16374671Geers 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neutral ginger-flavored drink described as energizing, hypoglycemic, caffeine-based drink and Neutral ginger-flavored drink in people with 3 Placebo Groups in a Cycle Ergometer Session With Healthy Participants, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Borg Rating of Perceived Exertion (time frame: 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06533137, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.