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OpenTrials
Completed

NCT Number: 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.

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Key information

Conditions

Performance Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health and Exercise Science Laboratory

Tampa, Florida, 33620, United States

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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy
  • physically active
  • non-smoker

Exclusion criteria

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

Treatment and study plan

NutraStem Active

Drug

NutraStem Placebo

Drug

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 9, 2014
Registry last updated
Dec 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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