Impact of Nutritional Supplementation on Aerobic Performance and Fatigue

Fatigue Clinical Trial

Official title:

Impact of Nutritional Supplementation on Aerobic Performance and Fatigue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02134756
• Other study ID #: USF-NS.Active-2014
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: May 2015

Study information

• Verified date: December 2015
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• healthy
• physically active
• non-smoker

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Fatigue
• Performance

Intervention

Drug:
• NutraStem Active

• NutraStem Placebo

Locations

Country	Name	City	State
United States	Health and Exercise Science Laboratory	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	28 days
Secondary	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).	28 days
Secondary	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).	28 days