Impact of Nutritional Supplementation on Aerobic Performance and Fatigue

NCT ID: NCT02134756

Last Updated: 2020-12-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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Performance Fatigue

Keywords

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Supplement impact Performance Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NutraStem Active

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

Group Type EXPERIMENTAL

NutraStem Active

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

NutraStem Placebo

Intervention Type DRUG

Interventions

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NutraStem Active

Intervention Type DRUG

NutraStem Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy
* physically active
* non-smoker

Exclusion Criteria

* known cardiovascular, pulmonary, or metabolic disease
* body mass index greater than 35
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marcus W Kilpatrick, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Danielle Williams

Role: STUDY_DIRECTOR

University of South Florida

Locations

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Health and Exercise Science Laboratory

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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USF-NS.Active-2014

Identifier Type: -

Identifier Source: org_study_id