Safety of a Ready to Drink Supplement

NCT ID: NCT03032549

Last Updated: 2017-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2016-09-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Dietary Supplements

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

RTD

Intervention Type DIETARY_SUPPLEMENT

Ready to Drink Supplement

Placebo

dextrose and non-caloric flavoring

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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RTD

Ready to Drink Supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Texas A&M University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard B Kreider, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas A&M University

Other Identifiers

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IRB2015-0754

Identifier Type: -

Identifier Source: org_study_id

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