Safety of a Ready to Drink Supplement (NB10)

Texas A&M University

Status: Completed

Conditions: Dietary Supplements

Treatments: Dietary Supplement: Placebo; Dietary Supplement: RTD

Study type: Interventional

Funder types: Other

Identifiers

NCT03032549

IRB2015-0754

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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28 participants in 2 patient groups, including a placebo group

RTD

Experimental group

Description:

2.1 g. beta alanine, 1.3 g arginine nitrate, 200 mg caffeine, 65 mg niacin, 325 mcg folic acid, 45 mcg vitamin B12

Treatment:

Dietary Supplement: RTD

Placebo

Placebo Comparator group

Description:

dextrose and non-caloric flavoring

Treatment:

Dietary Supplement: Placebo