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Impact of Nutritional Supplementation on Aerobic Performance and Fatigue

Primary Purpose

Performance, Fatigue

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NutraStem Active
NutraStem Placebo
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Performance focused on measuring Supplement impact, Performance, Fatigue

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy
  • physically active
  • non-smoker

Exclusion Criteria:

  • known cardiovascular, pulmonary, or metabolic disease
  • body mass index greater than 35

Sites / Locations

  • Health and Exercise Science Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NutraStem Active

Placebo

Arm Description

Daily supplementation with NutraStem Active; 2 capsules per day for 28 days

Daily supplementation with placebo; 2 capsules per day for 28 days

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).

Full Information

First Posted
April 11, 2014
Last Updated
November 12, 2020
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02134756
Brief Title
Impact of Nutritional Supplementation on Aerobic Performance and Fatigue
Official Title
Impact of Nutritional Supplementation on Aerobic Performance and Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Performance, Fatigue
Keywords
Supplement impact, Performance, Fatigue

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NutraStem Active
Arm Type
Experimental
Arm Description
Daily supplementation with NutraStem Active; 2 capsules per day for 28 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily supplementation with placebo; 2 capsules per day for 28 days
Intervention Type
Drug
Intervention Name(s)
NutraStem Active
Intervention Type
Drug
Intervention Name(s)
NutraStem Placebo
Primary Outcome Measure Information:
Title
Perceived Exertion
Description
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
Secondary Outcome Measure Information:
Title
Perceived Fatigue
Description
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
Title
Perceived Energy
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy physically active non-smoker Exclusion Criteria: known cardiovascular, pulmonary, or metabolic disease body mass index greater than 35
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus W Kilpatrick, PhD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Danielle Williams
Organizational Affiliation
University of South Florida
Official's Role
Study Director
Facility Information:
Facility Name
Health and Exercise Science Laboratory
City
Tampa
State/Province
Florida
ZIP/Postal Code
33620
Country
United States

12. IPD Sharing Statement

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Impact of Nutritional Supplementation on Aerobic Performance and Fatigue

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