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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03977246
Other study ID # OpenPlaceboCycling
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date September 30, 2018

Study information

Verified date June 2019
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date September 30, 2018
Est. primary completion date August 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Open-placebo
Application of the open-placebo intervention
Control
Application of the control session

Locations

Country Name City State
Brazil School of Physical Education and Sport - USP Sao Paulo
Brazil University of Sao Paulo Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Exercise performance Change in 1 km cycling time-trial performance 20-min following open-placebo intervention
Secondary Blood lactate Change in blood lactate concentration Immediately post-exercise
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