NCT02952014

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

February 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
Last Updated

November 2, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

September 13, 2016

Last Update Submit

October 30, 2016

Conditions

Dietary Modification

Outcome Measures

Primary Outcomes (6)

  • Optimize nutrient delivery prior to exercise by assessing; cognitive function (i.e., Stroop Color and Word Test and Word Recall Test).

    Three weeks

  • Optimize nutrient delivery prior to exercise by assessing Readiness to Perform Visual Analog Scale.

    Three weeks

  • Optimize nutrient delivery prior to exercise by assessing Resting Energy Expenditure.

    Three weeks

  • Optimize nutrient delivery prior to exercise by assessing Heart Rate.

    Three weeks

  • Optimize nutrient delivery prior to exercise by assessing Blood Pressure.

    Three weeks

  • Optimize nutrient delivery prior to exercise by assessing ECG.

    Three weeks

Secondary Outcomes (4)

  • Measure standard clinical chemistry panels in the blood to evaluate safety.

    Three weeks

  • Measure Heart Rate to evaluate safety.

    Three weeks

  • Measure Blood Pressure to evaluate safety.

    Three weeks

  • Measure ECG to evaluate safety.

    Three weeks

Study Arms (3)

C4 Extreme

EXPERIMENTAL

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.

Dietary Supplement: C4 Extreme

C4 Extreme (without Advantra Z)

ACTIVE COMPARATOR

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.

Dietary Supplement: C4 Extreme (without Advantra Z

Placebo

PLACEBO COMPARATOR

One dose of flavored placebo (powder mixed with water)

Dietary Supplement: Placebo

Interventions

C4 ExtremeDIETARY_SUPPLEMENT

Pre-Workout Dietary Supplement

C4 Extreme
C4 Extreme (without Advantra ZDIETARY_SUPPLEMENT

Pre-Workout Dietary Supplement

C4 Extreme (without Advantra Z)
PlaceboDIETARY_SUPPLEMENT

Pre-Workout Dietary Supplement

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise & Sport Nutrition Laboratory

College Station, Texas, 77843, United States

Location

Related Publications (1)

  • 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.

    PMID: 28096758DERIVED

Study Officials

  • Richard B Kreider, PhD

    Texas A&M University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2016

First Posted

November 2, 2016

Study Start

February 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

November 2, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)