Effects of PRJ-205 on Performance in Trained Young Subjects

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: PRJ-205
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated<br>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<br>* 1 sachet per day<br>|
| Placebo Comparator: Placebo<br>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<br>* 1 sachet per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Performance