Effect of Open-placebo Intervention on Cycling Performance

The Effect of an Open-placebo Intervention on Cycling Time-trial Performance

This study evaluates the effect of an open-label placebo intervention on cycling time-trial performance.

Study Overview

• Status: Completed
• Conditions: Exercise Performance
• Intervention / Treatment: Behavioral: Open-placebo; Behavioral: Control

Detailed Description

This study investigated the effect of open-placebo on cycling time-trial (TT) performance. Twenty-eight trained female cyclists completed a 1-km cycling TT following a control session or an open-placebo intervention. The intervention consisted of an individual presentation, provided by a medic, in which the concept of open-placebo was explained to the participant, before she ingested two red and white capsules containing flour; 15 min later, they performed the TT. In the control session, the participant sat quietly for 20 min.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05508-30
    • University of Sao Paulo
  • Sao Paulo, Brazil, 05508030
    • School of Physical Education and Sport - USP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Females aged between 18 and 45 years old;
• A minimum of one-year training experience in cycling.

Exclusion Criteria:

• Smokers
• Chronic disease
• Prior or current use of steroids
• Use of creatine in the last 6 months
• Use of beta-alanine in the last 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open-placebo; The open-placebo intervention session	Behavioral: Open-placebo; Application of the open-placebo intervention
Placebo Comparator: Control; The control session	Behavioral: Control; Application of the control session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise performance	Change in 1 km cycling time-trial performance	20-min following open-placebo intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood lactate	Change in blood lactate concentration	Immediately post-exercise

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Bruno Gualano, PhD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): August 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (Actual): June 6, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2019
• Last Update Submitted That Met QC Criteria: June 5, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: OpenPlaceboCycling

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