PerformanceNCT02134756
Impact of Nutritional Supplementation on Aerobic Performance and Fatigue
A study testing NutraStem Active in people with Performance and Fatigue, run by University of South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Performance, Fatigue
- What is being tested?
- NutraStem Active
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- physically active
- non-smoker
Who cannot join
- known cardiovascular, pulmonary, or metabolic disease
- body mass index greater than 35
Trial locations and contacts
1 site in 1 country.
United States1 site
Health and Exercise Science Laboratory
Tampa, Florida, 33620
About this study
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.
Read the 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.
- Conditions
- Performance, Fatigue
- Being tested
- NutraStem Active, NutraStem Placebo
- Keywords
- Supplement impact, Performance, Fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutraStem ActiveDrug
NutraStem PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| NutraStem Active | Experimental | Daily supplementation with NutraStem Active; 2 capsules per day for 28 days Receives: Drug: NutraStem Active |
| Placebo | Placebo comparator | Daily supplementation with placebo; 2 capsules per day for 28 days Receives: Drug: NutraStem Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 28 days
Secondary outcomes (2)
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).
Measured: 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).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PerformanceStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcus W Kilpatrick, PhD, Principal investigator, University of South FloridaDanielle Williams, Study director, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134756
- Sponsor's protocol ID
- USF-NS.Active-2014
- Status last verified
- Dec 2015
- First submitted
- 11 Apr 2014
- Last updated
- 7 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nutritional Supplementation on Aerobic Performance and Fatigue
- ClinicalTrials.gov ID
- NCT02134756
- Acronym / sponsor ID
- USF-NS.Active-2014
- Conditions
- Performance, Fatigue
- Keywords
- Supplement impact, Performance, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 May 2014 (estimated)
- Results
- Posted 7 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NutraStem Active | Experimental | Drug: NutraStem ActiveDaily supplementation with NutraStem Active; 2 capsules per day for 28 days |
| Placebo | Placebo comparator | Drug: NutraStem PlaceboDaily supplementation with placebo; 2 capsules per day for 28 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy
- physically active
- non-smoker
Key exclusion criteria (2 listed)
- known cardiovascular, pulmonary, or metabolic disease
- body mass index greater than 35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NutraStem Active | Drug | NutraStem Active |
| NutraStem Placebo | Drug | Placebo |
Primary outcome
Perceived Exertion
Time frame: 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).
2 secondary outcomes
Perceived Fatigue
Time frame: 28 days
Perceived Energy
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus W Kilpatrick, PhD principal investigator
University of South Florida
Danielle Williams study director
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NutraStem Active in people with Performance and Fatigue, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Exertion (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.