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Safety of a Ready to Drink Supplement (NB10)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032549
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Texas A&M University

Brief Summary:
This study will examine a Ready to Drink (RTD) supplement.

Condition or disease Intervention/treatment Phase
Dietary Supplements Dietary Supplement: RTD Dietary Supplement: Placebo Not Applicable

Detailed Description:
This study will examine the short-term (7 days) characteristics of ingesting a Ready to Drink (RTD) supplement immediately prior to exercise on the blood, heart rate, blood pressure and self-reported side effects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Short-Term Safety and Dose Effects of a Ready to Drink Pre-Workout Supplement
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : September 1, 2016
Actual Study Completion Date : September 1, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RTD
2.1 g. beta alanine, 1.3 g arginine nitrate, 200 mg caffeine, 65 mg niacin, 325 mcg folic acid, 45 mcg vitamin B12
Dietary Supplement: RTD
Ready to Drink Supplement

Placebo Comparator: Placebo
dextrose and non-caloric flavoring
Dietary Supplement: Placebo
Placebo




Primary Outcome Measures :
  1. The effects of ingesting an RTD immediately prior to exercise on the blood [ Time Frame: 7 days ]
  2. The effects of ingesting an RTD immediately prior to exercise on heart rate [ Time Frame: 7 days ]
  3. The effects of ingesting an RTD immediately prior to exercise on blood pressure [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. The effects of ingesting an RTD immediately prior to exercise on self-reported side effects [ Time Frame: 7 days ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Participants are apparently healthy and recreationally active males and females between the ages of 18 and 40

Exclusion Criteria:

  • Participants are under 18 years old and above 40 years old
  • Participants have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmias and/or cardiovascular disease
  • Participants currently use any prescription medication (birth control is allowed)
  • Participants are pregnant or lactating females or plan to become pregnant within the next month
  • Participants have a history of smoking
  • Participants drink excessively (12 drinks per week or more)
  • Participants have a recent history of creatine supplementation within 8 weeks of the start of supplementation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032549


Sponsors and Collaborators
Texas A&M University
Investigators
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Principal Investigator: Richard B Kreider, PhD Texas A&M University
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Responsible Party: Texas A&M University
ClinicalTrials.gov Identifier: NCT03032549    
Other Study ID Numbers: IRB2015-0754
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No