NCT03977246

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
Last Updated

June 7, 2019

Status Verified

June 1, 2019

Enrollment Period

4 months

First QC Date

June 4, 2019

Last Update Submit

June 5, 2019

Conditions

Exercise Performance

Outcome Measures

Primary Outcomes (1)

  • Exercise performance

    Change in 1 km cycling time-trial performance

    20-min following open-placebo intervention

Secondary Outcomes (1)

  • Blood lactate

    Immediately post-exercise

Study Arms (2)

Open-placebo

EXPERIMENTAL

The open-placebo intervention session

Behavioral: Open-placebo

Control

PLACEBO COMPARATOR

The control session

Behavioral: Control

Interventions

Open-placeboBEHAVIORAL

Application of the open-placebo intervention

Open-placebo
ControlBEHAVIORAL

Application of the control session

Control

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Sao Paulo

São Paulo, 05508-30, Brazil

Location

School of Physical Education and Sport - USP

São Paulo, 05508030, Brazil

Location

Study Officials

  • Bruno Gualano, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 4, 2019

First Posted

June 6, 2019

Study Start

May 1, 2018

Primary Completion

August 30, 2018

Study Completion

September 30, 2018

Last Updated

June 7, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

BR(2)