Effects of PRJ-205 on Performance in Trained Young Subjects

NCT ID: NCT02726516

Last Updated: 2016-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Compare a dietary supplement (PRJ-205) and placebo during 1 or 4 days on aerobic exercise performance, oxidative stress and muscle damage.

The hypothesis is that supplementation with PRJ-205 improve aerobic performance

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Twenty young active males will be recruited and randomized to either placebo or PRJ-205. Subjects will take the designated treatment in an acute dosage and chronically, 4 days of treatment.

They will undergo 3 exercise tasks (before the administration of the product, 1.5h after the acute administration of the product and after 4 days of treatment). VO2max and anaerobic threshold will be measured during the tests. Blood samples will be taken to measure muscle damage and oxidative stress.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Performance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treated

Treated volunteers will be administered one dose of PRJ-205 1,5 hours before the exercise task for the acute testing and will be taking one dose per day of PRJ-205 for 4 days for the chronic testing.

Group Type EXPERIMENTAL

PRJ-205

Intervention Type DIETARY_SUPPLEMENT

1 sachet per day

Placebo

Placebo volunteers will be administered one dose of placebo 1,5 hours before the exercise task for the acute testing and will be taking one dose per day of placebo for 4 days for the chronic testing.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

1 sachet per day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PRJ-205

1 sachet per day

Intervention Type DIETARY_SUPPLEMENT

Placebo

1 sachet per day

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male
* Healthy
* Physically active

Exclusion Criteria

* known cardiovascular, pulmonary or metabolic disease
* any medical condition that could affect the development and safety of the exercise task
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Valencia

OTHER

Sponsor Role collaborator

Bioiberica

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jose ViƱa, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidad de Valencia

Valencia, Valencia, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PRJ-205

Identifier Type: -

Identifier Source: org_study_id