Impact of Nutritional Supplementation on Aerobic Performance and Fatigue

Study Overview
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Brief Summary
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Compare an over-the-counter dietary supplement (NutraStem Active®) and placebo over a 30-day intervention on aerobic exercise performance and fatigue. The hypothesis is that supplementation with NutraStem Active® improve aerobic performance and reduce subjective measures of fatigue.

Detailed Description
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Compare an over-the-counter dietary supplement (NutraStem Active®) and placebo over a 30-day intervention on aerobic exercise performance and fatigue. The hypothesis is that supplementation with NutraStem Active® improve aerobic performance and reduce subjective measures of fatigue. The basic protocol includes baseline assessment of fitness and participation in a vigorous session of exercise immediately before and 30 days after consumption of the experimental supplement or placebo. The exercise task is intended to be fatiguing and demanding but is not expected to create failure. The supplement makes claims related to boosting exercise performance and reducing fatigue. The study design will determine if these outcomes are in fact present in a group of healthy, young, and active adults. The primary dependent measures are perceived exertion during exercise and levels of fatigue measured on multiple non-exercise days.

Official Title
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Impact of Nutritional Supplementation on Aerobic Performance and Fatigue

Conditions
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Fatigue, Performance

Intervention / Treatment
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* Drug: NutraStem Active
* Drug: NutraStem Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy physically active non-smoker Exclusion Criteria: known cardiovascular, pulmonary, or metabolic disease body mass index greater than 35

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

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

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NutraStem Active<br>Daily supplementation with NutraStem Active; 2 capsules per day for 28 days | Drug: NutraStem Active<br> <br> |
| Placebo Comparator: Placebo<br>Daily supplementation with placebo; 2 capsules per day for 28 days | Drug: NutraStem Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Exertion | Ratings of perceived exertion (RPE) as measured on a self-report scale. The scale is a single-item measure ranging from 0 (no exertion) to 10 (max exertion). | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Fatigue | Ratings of perceived fatigue as measured on a self-report scale. The scale is a single-item measure ranging from 1 (not at all) to 5 (extremely). | 28 days | 
| Perceived Energy | Ratings of perceived energy as measured on a self-report scale. The scale is a single-item measure ranging from 1 (not at all) to 5 (extremely). | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supplement impact, Performance, Fatigue