NB10: Safety of a Ready to Drink Supplement

• Sponsor: Texas A&M University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03032549
• Collaborator: (none)
• Enrollment: 28
• Arms: 2
• Actual Duration (Months): 8

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Jan 1, 2016
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The effects of ingesting an RTD immediately prior to exercise on the blood [7 days]

2. The effects of ingesting an RTD immediately prior to exercise on heart rate [7 days]

3. The effects of ingesting an RTD immediately prior to exercise on blood pressure [7 days]

Secondary Outcome Measures

1. The effects of ingesting an RTD immediately prior to exercise on self-reported side effects [7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Texas A&M University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Texas A&M University
• ClinicalTrials.gov Identifier: NCT03032549
• Other Study ID Numbers: IRB2015-0754
• First Posted: Jan 26, 2017
• Last Update Posted: Jan 26, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 26, 2017