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CompletedNCT02726516Updated Dec 1, 2016

Effects of PRJ-205 on Performance in Trained Young Subjects

An interventional study of PRJ-205 and Placebo in Healthy, sponsored by Bioiberica. Completed at 1 site in Spain. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-01.

Sponsored by Bioiberica · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Male
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Healthy

Keywords

  • Performance
03

In context

Lead sponsor

Bioiberica is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male
  • Healthy
  • Physically active

Exclusion criteria

Exclusion Criteria:

  • known cardiovascular, pulmonary or metabolic disease
  • any medical condition that could affect the development and safety of the exercise task
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    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.

    Dietary Supplement: PRJ-205

  • Placebo comparator
    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.

    Other: Placebo

Interventions

  • Dietary supplementPRJ-205

    1 sachet per day

  • OtherPlacebo

    1 sachet per day

06

What researchers measure

Primary outcomes

  1. Aerobic performance determined by VO2max

    Time frame: 4 days

Secondary outcomes

  1. Pressure pain threshold of calf muscle

    Measured pre- and post- exercise task

    Time frame: 4 days

  2. Serum markers of muscular damage

    Measured from blood samples taken pre- and post- exercise task.

    Time frame: 4 days

  3. Oxidative stress parameters

    Measured from blood samples taken pre- and post- exercise task.

    Time frame: 4 days

07

Study locations

1 site
  • Universidad de Valencia
    Valencia, Comunidad Valenciana 46010, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02726516
Lead sponsor
Bioiberica
Collaborators
University of Valencia
Responsible party
Sponsor
First posted
Apr 1, 2016
Start date
Mar 2016
Primary completion
Apr 2016
Completion
Jun 2016
Last update
Dec 1, 2016

Study contacts

Jose Viña, PhD
principal investigator · University of Valencia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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