Impact of Nutritional Supplementation on Aerobic Performance and Fatigue

November 12, 2020 updated by: University of South Florida

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

Completed

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

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33620
        • Health and Exercise Science Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy
  • physically active
  • non-smoker

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: NutraStem Active
Placebo Comparator: Placebo
Daily supplementation with placebo; 2 capsules per day for 28 days
Drug: NutraStem Placebo

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

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Investigators

  • Principal Investigator: Marcus W Kilpatrick, PhD, University of South Florida
  • Study Director: Danielle Williams, University of South Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

April 11, 2014

First Submitted That Met QC Criteria

May 8, 2014

First Posted (Estimate)

May 9, 2014

Study Record Updates

Last Update Posted (Actual)

December 7, 2020

Last Update Submitted That Met QC Criteria

November 12, 2020

Last Verified

December 1, 2015

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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