Dietary SupplementsNB10NCT03032549
Safety of a Ready to Drink Supplement
A study testing RTD in people with Dietary Supplements, run by Texas A&M University.
Trial summary
This study will examine a Ready to Drink (RTD) supplement. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Supplements
- What is being tested?
- RTD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants are apparently healthy and recreationally active males and females between the ages of 18 and 40
Who cannot join
- 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
About this study
Official title: Short-Term Safety and Dose Effects of a Ready to Drink Pre-Workout Supplement
This study will examine a Ready to Drink (RTD) supplement.
Read the 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.
- Conditions
- Dietary Supplements
- Being tested
- RTD, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTDDietary supplement
Ready to Drink Supplement
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: RTD |
| Placebo | Placebo comparator | dextrose and non-caloric flavoring Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of ingesting an RTD immediately prior to exercise on the blood
Measured: 7 days
The effects of ingesting an RTD immediately prior to exercise on heart rate
Measured: 7 days
The effects of ingesting an RTD immediately prior to exercise on blood pressure
Measured: 7 days
Secondary outcomes (1)
The effects of ingesting an RTD immediately prior to exercise on self-reported side effects
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start1 Jan 2016
- Primary completion1 Sep 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary SupplementsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard B Kreider, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032549
- Sponsor's protocol ID
- IRB2015-0754
- Acronym
- NB10
- Status last verified
- Jan 2017
- First submitted
- 20 Jan 2017
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Safety and Dose Effects of a Ready to Drink Pre-Workout Supplement
- ClinicalTrials.gov ID
- NCT03032549
- Acronym / sponsor ID
- NB10 / IRB2015-0754
- Conditions
- Dietary Supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine a Ready to Drink (RTD) supplement.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RTD | Experimental | Dietary Supplement: RTD2.1 g. beta alanine, 1.3 g arginine nitrate, 200 mg caffeine, 65 mg niacin, 325 mcg folic acid, 45 mcg vitamin B12 |
| Placebo | Placebo comparator | Dietary Supplement: Placebodextrose and non-caloric flavoring |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants are apparently healthy and recreationally active males and females between the ages of 18 and 40
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RTDReady to Drink Supplement | Dietary supplement | RTD |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
The effects of ingesting an RTD immediately prior to exercise on the blood
Time frame: 7 days
The effects of ingesting an RTD immediately prior to exercise on heart rate
Time frame: 7 days
The effects of ingesting an RTD immediately prior to exercise on blood pressure
Time frame: 7 days
1 secondary outcome
The effects of ingesting an RTD immediately prior to exercise on self-reported side effects
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard B Kreider, PhD principal investigator
Texas A&M University
Questions about this trial
What is this clinical trial studying?
A study testing RTD in people with Dietary Supplements, run by Texas A&M University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effects of ingesting an RTD immediately prior to exercise on the blood (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.