Safety of a Ready to Drink Supplement (NB10)

Short-Term Safety and Dose Effects of a Ready to Drink Pre-Workout Supplement

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

Study Overview

• Status: Completed
• Conditions: Dietary Supplements
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: RTD

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The effects of ingesting an RTD immediately prior to exercise on the blood	7 days
The effects of ingesting an RTD immediately prior to exercise on heart rate	7 days
The effects of ingesting an RTD immediately prior to exercise on blood pressure	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
The effects of ingesting an RTD immediately prior to exercise on self-reported side effects	7 days

Collaborators and Investigators

• Sponsor: Texas A&M University
• Investigators: Principal Investigator: Richard B Kreider, PhD, Texas A&M University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: January 20, 2017
• First Submitted That Met QC Criteria: January 23, 2017
• First Posted (Estimate): January 26, 2017

Study Record Updates

• Last Update Posted (Estimate): January 26, 2017
• Last Update Submitted That Met QC Criteria: January 23, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: IRB2015-0754

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No