Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02999581
Other study ID # IRB2014-0079FX
Secondary ID
Status Completed
Phase N/A
First received December 16, 2016
Last updated December 16, 2016
Start date March 2014
Est. completion date December 2014

Study information

Verified date December 2016
Source Texas A&M University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the effects of a pre-workout dietary supplement during resistance training on training adaptations.


Description:

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 effects of ingesting a pre-workout dietary supplement during resistance training on training adaptations.


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- you are an apparently healthy and recreationally active male 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, hypotension, 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 have a history of smoking;

- you drink excessively (i.e., 12 drinks per week or more);

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
C4 Extreme, C4 Extreme (without Advantra Z)


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Texas A&M University Nutrabolt

Outcome

Type Measure Description Time frame Safety issue
Primary Examine the effects of C4 supplementation during resistance training by assessing body water Eight weeks No
Primary Examine the effects of C4 supplementation during resistance training by assessing body composition Eight weeks No
Primary Examine the effects of C4 supplementation during resistance training by assessing macronutrient intake Eight weeks No
Primary Examine the effects of C4 supplementation during resistance training by assessing 1 RM (repetition maximum) strength Eight weeks No
Primary Examine the effects of C4 supplementation during resistance training by assessing anaerobic sprint capacity Eight weeks No
Primary Examine the effects of C4 supplementation during resistance training by assessing muscle creatine levels Eight weeks No
Primary Examine the effects of C4 supplementation during resistance training by assessing muscle carnosine levels Eight weeks No
Primary Examine the effects of C4 supplementation during resistance training by assessing cognitive function (i.e., Stroop Color and Word Test, Word Recall Test and Readiness to perform VAS) Eight weeks No
Secondary Measure standard clinical chemistry panels in the blood to evaluate safety Eight weeks Yes
Secondary Record side effects to evaluate safety Eight weeks Yes
Secondary Measure heart rate to evaluate safety Eight weeks Yes
Secondary Measure blood pressure to evaluate safety Eight weeks Yes
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03586622 - One Year Home Monitoring and Treatment of IBS Patients N/A
Not yet recruiting NCT02858557 - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases N/A
Completed NCT02589769 - Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons N/A
Withdrawn NCT02863822 - Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia. N/A
Completed NCT03048487 - Protein Consumption in Critically Ill Patients
Completed NCT03024983 - Pasta and Other Durum Wheat-based Products: Effects on Post-prandial Glucose Metabolism N/A
Completed NCT02480504 - Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity N/A
Recruiting NCT02848807 - Chemotherapy-related Toxicity, Nutritional Status and Quality of Life N/A
Completed NCT02416284 - Compliance to the Norwegian Food-Based Dietary Guidelines in Young Females N/A
Completed NCT01559896 - Egg Protein Hydrolysate and Vascular Function N/A
Terminated NCT01329172 - Nasal Mucin Oral Supplementation Treatment Respiratory Inflammation Using PUFA in Cystic Fibrosis (CF) Patients N/A
Completed NCT03698929 - Effect of Dietary Cholesterol on Plasma Lipids N/A
Completed NCT03942822 - Chia Supplementation and Non Alcoholic Fatty Liver Disease N/A
Completed NCT03319836 - Meeting Protein Targets in Critically Ill Patients
Completed NCT02940197 - Comparison of Two Calorie Restricted MediterrAsian Diet on Weight Loss in FTO rs9939609 Overweight Carriers N/A
Completed NCT02811276 - The Impact of a High Protein Diet on Substrate Oxidation and Energy Metabolism N/A
Completed NCT02582554 - Efficacy of Nutrition Risk Screening With NutriSTEP® in Toddlers and Preschoolers N/A
Completed NCT02574052 - Medical College Students' Responds to Menu Labeling Phase 3
Completed NCT02274220 - Feeding Study - Effects Post-cardiac Surgery N/A
Completed NCT02898844 - Randomized Controlled Experiment of Dieting in Pairs N/A