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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NutraStem Active | Experimental | Daily supplementation with NutraStem Active; 2 capsules per day for 28 days |
|
| Placebo | Placebo Comparator | Daily supplementation with placebo; 2 capsules per day for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NutraStem Active | Drug |
| ||
| NutraStem Placebo |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcus W Kilpatrick, PhD | University of South Florida | Principal Investigator |
| Danielle Williams | University of South Florida | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health and Exercise Science Laboratory | Tampa | Florida | 33620 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | NutraStem Active | 2 capsules per day for 28 days |
| FG001 | Placebo | 2 capsules per day for 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NutraStem Active | Daily supplementation with NutraStem Active; 2 capsules per day for 28 days NutraStem Active |
| BG001 | Placebo | Daily supplementation with placebo; 2 capsules per day for 28 days NutraStem Active |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | units on a scale | 28 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NutraStem Active | Daily supplementation with NutraStem Active; 2 capsules per day for 28 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marcus Kilpatrick | University of South Florida | (813) 362-6696 | mkilpatrick@usf.edu |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 28 days |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Perceived Exertion |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Perceived Exertion | Mean | Standard Deviation | units on a scale |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | 28 days |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | 28 days |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Placebo | Daily supplementation with placebo; 2 capsules per day for 28 days | 0 | 15 | 0 | 15 | 0 | 15 |
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