Effects of PRJ-205 on Performance in Trained Young Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: PRJ-205; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Comunidad Valenciana
    • Valencia, Comunidad Valenciana, Spain, 46010
      • Universidad de Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 1 sachet per day
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; 1 sachet per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Aerobic performance determined by VO2max	4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure pain threshold of calf muscle	Measured pre- and post- exercise task	4 days
Serum markers of muscular damage	Measured from blood samples taken pre- and post- exercise task.	4 days
Oxidative stress parameters	Measured from blood samples taken pre- and post- exercise task.	4 days

Collaborators and Investigators

• Sponsor: Bioiberica
• Collaborators: University of Valencia
• Investigators: Principal Investigator: Jose Viña, PhD, University of Valencia

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: March 29, 2016
• First Posted (Estimate): April 1, 2016

Study Record Updates

• Last Update Posted (Estimate): December 1, 2016
• Last Update Submitted That Met QC Criteria: November 30, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Performance
• Other Study ID Numbers: PRJ-205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED