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OpenTrials
Completed

NCT Number: NCT02726516

Effects of PRJ-205 on Performance in Trained Young Subjects

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

Completed

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Key information

Conditions

Healthy

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Valencia

Valencia, 46010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRJ-205

Dietary Supplement

1 sachet per day

Placebo

Other

1 sachet per day

Primary outcomes

  1. Aerobic performance determined by VO2max

    Time frame: 4 days

Secondary outcomes

  1. Pressure pain threshold of calf muscle

    Time frame: 4 days

    Measured pre- and post- exercise task

  2. Serum markers of muscular damage

    Time frame: 4 days

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

  3. Oxidative stress parameters

    Time frame: 4 days

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

Sponsors and collaborators

Lead sponsor

Bioiberica

Industry

Collaborators

  • University of Valencia

Registry information

Official study title

Effects of PRJ-205 on Performance in Trained Young Subjects After Acute and Chronic Intake of the Study Product

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 1, 2016
Registry last updated
Dec 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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