Safety of a Ready to Drink Supplement

Dietary Supplements Clinical Trial

— NB10  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03032549
• Other study ID #: IRB2015-0754
• Status: Completed
• Phase: N/A
• First received: January 20, 2017
• Last updated: January 23, 2017
• Start date: January 1, 2016
• Est. completion date: September 1, 2016

Study information

• Verified date: January 2017
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 1, 2016
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Supplements

Intervention

Dietary Supplement:
• RTD
Ready to Drink Supplement
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Texas A&M University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effects of ingesting an RTD immediately prior to exercise on the blood		7 days
Primary	The effects of ingesting an RTD immediately prior to exercise on heart rate		7 days
Primary	The effects of ingesting an RTD immediately prior to exercise on blood pressure		7 days
Secondary	The effects of ingesting an RTD immediately prior to exercise on self-reported side effects		7 days