Effects of PRJ-205 on Performance in Trained Young Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726516
• Other study ID #: PRJ-205
• Status: Completed
• Phase: N/A
• First received: March 23, 2016
• Last updated: November 30, 2016
• Start date: March 2016
• Est. completion date: June 2016

Study information

• Verified date: November 2016
• Source: Bioiberica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• PRJ-205
1 sachet per day

Other:
• Placebo
1 sachet per day

Locations

Country	Name	City	State
Spain	Universidad de Valencia	Valencia	Comunidad Valenciana

Sponsors (2)

Lead Sponsor	Collaborator
Bioiberica	University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aerobic performance determined by VO2max		4 days	No
Secondary	Pressure pain threshold of calf muscle	Measured pre- and post- exercise task	4 days	No
Secondary	Serum markers of muscular damage	Measured from blood samples taken pre- and post- exercise task.	4 days	No
Secondary	Oxidative stress parameters	Measured from blood samples taken pre- and post- exercise task.	4 days	No