NCT03022604

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

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

June 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

3 months

First QC Date

January 12, 2017

Last Update Submit

January 20, 2017

Conditions

Outcome Measures

Primary Outcomes (8)

  • Effects of a Pre-Workout Dietary Supplement on the Stroop Color and Word Test

    Seven Days

  • Effects of a Pre-Workout Dietary Supplement on the Word Recall Test

    Seven Days

  • Effects of a Pre-Workout Dietary Supplement on VAS Readiness to Perform

    Seven Days

  • Effects of a Pre-Workout Dietary Supplement on anaerobic sprint capacity on a bicycle ergometer

    Seven Days

  • Effects of a Pre-Workout Dietary Supplement on bench press power output

    Seven Days

  • Effects of a Pre-Workout Dietary Supplement on leg press power output

    Seven Days

  • Effects of a Pre-Workout Dietary Supplement on total work on the bench press

    Seven Days

  • Effects of a Pre-Workout Dietary Supplement on total work on the leg press

    Seven Days

Secondary Outcomes (5)

  • Effects of a Pre-Workout Dietary Supplement on energy expenditure

    Seven Days

  • Effects of a Pre-Workout Dietary Supplement on heart rate

    Seven Days

  • Effects of a Pre-Workout Dietary Supplement on blood pressure

    Seven Days

  • Effects of a Pre-Workout Dietary Supplement on ECG's

    Seven Days

  • Effects of a Pre-Workout Dietary Supplement on blood lab results

    Seven Days

Study Arms (3)

C4/Generation 4

EXPERIMENTAL

12 grams of C4/Generation 4 Extreme

Dietary Supplement: C4/Generation 4

C450X

ACTIVE COMPARATOR

12 grams of C4X (150% of regular dose)

Dietary Supplement: C450X

Placebo

PLACEBO COMPARATOR

12 grams of flavored dextrose

Dietary Supplement: Placebo

Interventions

C4/Generation 4DIETARY_SUPPLEMENT

12 grams of C4/Generation 4

C4/Generation 4
C450XDIETARY_SUPPLEMENT

12 grams of C450X

C450X
PlaceboDIETARY_SUPPLEMENT

12 grams of flavored dextrose

Placebo

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

January 12, 2017

First Posted

January 16, 2017

Study Start

June 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

January 24, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share