Assessment of a Pre-Workout Supplement (NB6)

January 20, 2017 updated by: Texas A&M University

Pharmacokinetic, Hemodynamic and Ergogenic Assessment of a Pre-Workout Dietary Supplement

This study is assessing the effects of a pre-workout dietary supplement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to examine the acute effects of a pre-workout dietary supplement at a standard dose and one that is delivered at 150% of the standard dose on energy metabolism, cardiovascular hemodynamics, blood metabolites and mental focus.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must be apparently healthy males and/or females between the ages of 18 and 40
  • Participants must have at least 6 months immediate prior history of resistance training including the bench press and leg press/squat

Exclusion Criteria:

  • Participants who have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmias and/or cardiovascular disease
  • Participants who currently use any prescription medication
  • Participants who are intolerant to caffeine and/or other natural stimulants
  • Participants who are pregnant or lactating women
  • Participants who have a history of smoking
  • Participants who drink excessively (12 drinks per week)

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: C4/Generation 4
12 grams of C4/Generation 4 Extreme
Dietary supplement: C4/Generation 4
12 grams of C4/Generation 4
Active Comparator: C450X
12 grams of C4X (150% of regular dose)
Dietary supplement: C450X
12 grams of C450X
Placebo Comparator: Placebo
12 grams of flavored dextrose
Dietary supplement: Placebo
12 grams of flavored dextrose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effects of a Pre-Workout Dietary Supplement on the Stroop Color and Word Test
Time Frame: Seven Days
Seven Days
Effects of a Pre-Workout Dietary Supplement on the Word Recall Test
Time Frame: Seven Days
Seven Days
Effects of a Pre-Workout Dietary Supplement on VAS Readiness to Perform
Time Frame: Seven Days
Seven Days
Effects of a Pre-Workout Dietary Supplement on anaerobic sprint capacity on a bicycle ergometer
Time Frame: Seven Days
Seven Days
Effects of a Pre-Workout Dietary Supplement on bench press power output
Time Frame: Seven Days
Seven Days
Effects of a Pre-Workout Dietary Supplement on leg press power output
Time Frame: Seven Days
Seven Days
Effects of a Pre-Workout Dietary Supplement on total work on the bench press
Time Frame: Seven Days
Seven Days
Effects of a Pre-Workout Dietary Supplement on total work on the leg press
Time Frame: Seven Days
Seven Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Effects of a Pre-Workout Dietary Supplement on energy expenditure
Time Frame: Seven Days
Seven Days
Effects of a Pre-Workout Dietary Supplement on heart rate
Time Frame: Seven Days
Seven Days
Effects of a Pre-Workout Dietary Supplement on blood pressure
Time Frame: Seven Days
Seven Days
Effects of a Pre-Workout Dietary Supplement on ECG's
Time Frame: Seven Days
Seven Days
Effects of a Pre-Workout Dietary Supplement on blood lab results
Time Frame: Seven Days
Seven Days

Collaborators and Investigators

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

Sponsor

Texas A&M University

Collaborators

Nutrabolt

Investigators

  • Principal Investigator: Richard B Kreider, PhD, Texas A&M University

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

June 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

January 12, 2017

First Posted (Estimate)

January 16, 2017

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • IRB2014-0795F

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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