- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02134756
Impact of Nutritional Supplementation on Aerobic Performance and 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33620
- Health and Exercise Science Laboratory
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy
- physically active
- non-smoker
Exclusion Criteria:
- known cardiovascular, pulmonary, or metabolic disease
- body mass index greater than 35
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NutraStem Active
Daily supplementation with NutraStem Active; 2 capsules per day for 28 days
|
|
Placebo Comparator: Placebo
Daily supplementation with placebo; 2 capsules per day for 28 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Fatigue
Time Frame: 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).
|
28 days
|
Perceived Energy
Time Frame: 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).
|
28 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marcus W Kilpatrick, PhD, University of South Florida
- Study Director: Danielle Williams, University of South Florida
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- USF-NS.Active-2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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