Fatigue, Performance
Conditions
Keywords
Supplement impact, Performance, Fatigue
Brief summary
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
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.
Interventions
DRUGNutraStem Active
DRUGNutraStem Placebo
Sponsors
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy * physically active * non-smoker
Exclusion criteria
* known cardiovascular, pulmonary, or metabolic disease * body mass index greater than 35
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Exertion | 28 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Fatigue | 28 days | 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). |
| Perceived Energy | 28 days | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NutraStem Active Daily supplementation with NutraStem Active; 2 capsules per day for 28 days
NutraStem Active | 15 |
| Placebo Daily supplementation with placebo; 2 capsules per day for 28 days
NutraStem Active | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | NutraStem Active | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 30 Participants |
| Age, Continuous | 23 Perceived Exertion STANDARD_DEVIATION 6 | 26 Perceived Exertion STANDARD_DEVIATION 7 | 25 Perceived Exertion STANDARD_DEVIATION 6 |
| Perceived Exertion | 7.5 units on a scale STANDARD_DEVIATION 1.7 | 7.5 units on a scale STANDARD_DEVIATION 1.8 | 7.5 units on a scale STANDARD_DEVIATION 1.8 |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
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).
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NutraStem Active | Perceived Exertion | 6.7 units on a scale | Standard Deviation 2 |
| Placebo | Perceived Exertion | 7.4 units on a scale | Standard Deviation 1.9 |
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).
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NutraStem Active | Perceived Energy | 4.1 units on a scale | Standard Deviation 1.7 |
| Placebo | Perceived Energy | 4.6 units on a scale | Standard Deviation 1.6 |
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).
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NutraStem Active | Perceived Fatigue | 5.8 units on a scale | Standard Deviation 1.9 |
| Placebo | Perceived Fatigue | 5.5 units on a scale | Standard Deviation 2.4 |