NCT03032549

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

January 20, 2017

Last Update Submit

January 23, 2017

Conditions

Dietary Supplements

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • The effects of ingesting an RTD immediately prior to exercise on self-reported side effects

    7 days

Study Arms (2)

RTD

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

dextrose and non-caloric flavoring

Dietary Supplement: Placebo

Interventions

RTDDIETARY_SUPPLEMENT

Ready to Drink Supplement

RTD
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants are apparently healthy and recreationally active males and females between the ages of 18 and 40

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Richard B Kreider, PhD

    Texas A&M University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2017

First Posted

January 26, 2017

Study Start

January 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

January 26, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share