Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT02134756
Status:
COMPLETED
Last Update Posted:
2020-12-07
First Post:
2014-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Impact of Nutritional Supplementation on Aerobic Performance and Fatigue
Sponsor:
University of South Florida
Organization:
Study Overview
Official Title:
Impact of Nutritional Supplementation on Aerobic Performance and Fatigue
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: