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Trial record 3 of 5 for:    alpha-ketoglutaric acid

Effects of a Pre-Workout Dietary Supplement on Training Adaptations (NB2)

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ClinicalTrials.gov Identifier: NCT02999581
Recruitment Status : Completed
First Posted : December 21, 2016
Last Update Posted : December 21, 2016
Sponsor:
Collaborator:
Nutrabolt
Information provided by (Responsible Party):
Texas A&M University

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

Condition or disease Intervention/treatment Phase
Dietary Modification Dietary Supplement: C4 Extreme, C4 Extreme (without Advantra Z) Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Effects of a Pre-Workout Dietary Supplement on Training Adaptations in Resistance Trained Athletes
Study Start Date : March 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: C4 Extreme
One dose of 12 grams (powder mixed with water): 1500 mg beta alanine, 1000 mg creatine nitrate, 1000 mg arginine alpha-ketoglutarate, 250 mg vitamin C, 150 mg N-Acetyl-Tyrosine, 135 mg caffeine, 7.5 mg L-Dopa, 30 mg vitamin B3, 10 mg Bitter Orange (Citrus Aurantium) fruit standardized for 30% synephrine (Advantra Z), 0.5 mg vitamin B6, 0.25 mg vitamin B9, and 0.035 mg vitamin B12.
Dietary Supplement: C4 Extreme, C4 Extreme (without Advantra Z)
Active Comparator: 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 alpha-ketoglutarate, 250 mg vitamin C, 150 mg N-Acetyl-Tyrosine, 135 mg caffeine, 7.5 mg L-Dopa, 30 mg vitamin B3, 0.5 mg vitamin B6, 0.25 mg vitamin B9, and 0.035 mg vitamin B12.
Dietary Supplement: C4 Extreme, C4 Extreme (without Advantra Z)
Placebo Comparator: Placebo
One dose of flavored placebo (powder mixed with water)
Dietary Supplement: C4 Extreme, C4 Extreme (without Advantra Z)



Primary Outcome Measures :
  1. Examine the effects of C4 supplementation during resistance training by assessing body water [ Time Frame: Eight weeks ]
  2. Examine the effects of C4 supplementation during resistance training by assessing body composition [ Time Frame: Eight weeks ]
  3. Examine the effects of C4 supplementation during resistance training by assessing macronutrient intake [ Time Frame: Eight weeks ]
  4. Examine the effects of C4 supplementation during resistance training by assessing 1 RM (repetition maximum) strength [ Time Frame: Eight weeks ]
  5. Examine the effects of C4 supplementation during resistance training by assessing anaerobic sprint capacity [ Time Frame: Eight weeks ]
  6. Examine the effects of C4 supplementation during resistance training by assessing muscle creatine levels [ Time Frame: Eight weeks ]
  7. Examine the effects of C4 supplementation during resistance training by assessing muscle carnosine levels [ Time Frame: Eight weeks ]
  8. 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) [ Time Frame: Eight weeks ]

Secondary Outcome Measures :
  1. Measure standard clinical chemistry panels in the blood to evaluate safety [ Time Frame: Eight weeks ]
  2. Record side effects to evaluate safety [ Time Frame: Eight weeks ]
  3. Measure heart rate to evaluate safety [ Time Frame: Eight weeks ]
  4. Measure blood pressure to evaluate safety [ Time Frame: Eight weeks ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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);

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Texas A&M University
ClinicalTrials.gov Identifier: NCT02999581     History of Changes
Other Study ID Numbers: IRB2014-0079FX
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No