Assessment of a Pre-Workout Dietary Supplement

NCT ID: NCT02952014

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to examine the acute effects of a pre-workout dietary supplement on energy metabolism, cardiovascular hemodynamics, blood metabolites and mental focus.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A number of nutritional strategies have been developed to optimize nutrient delivery prior to exercise. This includes providing carbohydrate and a number of ergogenic nutrients prior to, during and/or following exercise. As a result a number of pre-workout supplements have been developed to increase energy availability, promote vasodilation and/or positively affect exercise capacity. The purpose of this study is to investigate the potential ergogenic value of acute ingestion of a pre-workout dietary supplement prior to exercise.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dietary Modification

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

C4 Extreme

One dose of 12 grams (powder mixed with water): 1500 mg beta alanine, 1000 mg creatine nitrate, 1000 mg arginine AKG, 250 mg vitamin C, 150 mg n-acetyle tyrosine, 135 mg caffeine, 7.5 mg l-dopa, 30 mg vitamin B3, 10 mg synephrine, 0.5 mg vitamin B6, 0.25 mg vitamin B9, 0.035 mg vitamin B12.

Group Type EXPERIMENTAL

C4 Extreme

Intervention Type DIETARY_SUPPLEMENT

Pre-Workout Dietary Supplement

C4 Extreme (without Advantra Z)

One dose of 12 grams (powder mixed with water): 1500 mg beta alanine, 1000 mg creatine nitrate, 1000 mg arginine AKG, 250 mg vitamin C, 150 mg n-acetyle tyrosine, 135 mg caffeine, 7.5 mg l-dopa, 30 mg vitamin B3, 0.5 mg vitamin B6, 0.25 mg vitamin B9, 0.035 mg vitamin B12.

Group Type ACTIVE_COMPARATOR

C4 Extreme (without Advantra Z

Intervention Type DIETARY_SUPPLEMENT

Pre-Workout Dietary Supplement

Placebo

One dose of flavored placebo (powder mixed with water)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Pre-Workout Dietary Supplement

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

C4 Extreme

Pre-Workout Dietary Supplement

Intervention Type DIETARY_SUPPLEMENT

C4 Extreme (without Advantra Z

Pre-Workout Dietary Supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo

Pre-Workout Dietary Supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* you are an apparently healthy and recreationally active man or woman between the ages of 18 and 40;
* you will need to have at least six months immediate prior history of resistance training on the bench press and leg press or squat;

Exclusion Criteria

* you have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypo-tension, thyroid disease, arrhythmia and/or cardiovascular disease;
* you are currently using prescription medications;
* you have an intolerance to caffeine and/or other natural stimulants;
* you are pregnant or a lactating female or plan to become pregnant with the next month;
* you have a history of smoking;
* you drink excessively (i.e., 12 drinks per week or more);
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nutrabolt

INDUSTRY

Sponsor Role collaborator

Texas A&M University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Richard B Kreider, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas A&M University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Exercise & Sport Nutrition Laboratory

College Station, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Jung YP, Earnest CP, Koozehchian M, Galvan E, Dalton R, Walker D, Rasmussen C, Murano PS, Greenwood M, Kreider RB. Effects of acute ingestion of a pre-workout dietary supplement with and without p-synephrine on resting energy expenditure, cognitive function and exercise performance. J Int Soc Sports Nutr. 2017 Jan 12;14:3. doi: 10.1186/s12970-016-0159-2. eCollection 2017.

Reference Type DERIVED
PMID: 28096758 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB2014-0022FX

Identifier Type: -

Identifier Source: org_study_id