NCT02134756

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 9, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

December 7, 2020

Completed
Last Updated

December 7, 2020

Status Verified

December 1, 2015

Enrollment Period

1 year

First QC Date

April 11, 2014

Results QC Date

July 16, 2019

Last Update Submit

November 12, 2020

Conditions

PerformanceFatigue

Keywords

Supplement impactPerformanceFatigue

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Perceived Fatigue

    28 days

  • Perceived Energy

    28 days

Study Arms (2)

NutraStem Active

EXPERIMENTAL

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

Drug: NutraStem Active

Placebo

PLACEBO COMPARATOR

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

Drug: NutraStem Placebo

Interventions

NutraStem ActiveDRUG
NutraStem Active
NutraStem PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • physically active
  • non-smoker

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health and Exercise Science Laboratory

Tampa, Florida, 33620, United States

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Marcus Kilpatrick
Organization
University of South Florida
mkilpatrick@usf.edu
(813) 362-6696

Study Officials

  • Marcus W Kilpatrick, PhD

    University of South Florida

    PRINCIPAL INVESTIGATOR

  • Danielle Williams

    University of South Florida

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2014

First Posted

May 9, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

December 7, 2020

Results First Posted

December 7, 2020

Record last verified: 2015-12

Locations

US(1)