HealthyNCT02255201
Pre-Workout on Exercise Performance and Cognition
A study testing Master Performance Blend Dose 1, Master Performance Blend Dose 2 and Performance Energy Blend in people with Healthy, run by Miami Research Associates at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of four different pre-workout beverages as compared to placebo on muscular strength and endurance, perceived energy and cognitive performance in healthy adult males. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Master Performance Blend Dose 1, Master Performance Blend Dose 2 and Performance Energy Blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jan 2015
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males, aged 18 to 40 years
- Subject has a waist circumference ≤ 97 cm.
- Subject is a non-smoker.
- Subject is in good health and appropriate for exercise as determined by physical examination, medical history and ECG.
- Subject is weight training for the 6 months prior to starting the trial.
- Subject agrees to not use any new vitamins and/or minerals until after study completion and to not take any vitamins and/or minerals 24 hours prior to the test visits.
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- Subject agrees to not use any dietary or herbal supplements until after study completion. A 7-day washout is allowed for study inclusion.
- Subject is willing and able to comply with the protocol including:
- Attending 5 visits each of which is approximately 4 hours long;
- Refraining from caffeine, over-the-counter medications and alcohol for the 24 hours prior to the test visits;
- Refraining from weight training for the 48 hours prior and refraining from any exercise other than weight training for 24 hours prior to the test visits;
- Refraining from taking any dietary or herbal supplements throughout the study.
- Subject is able to understand and sign the informed consent to participate in the study.
Who cannot join
- Subject has any of the following medical conditions:
- active heart disease
- uncontrolled high blood pressure (≥ 140/90 mmHg)
- renal or hepatic impairment/disease
- Type I or II diabetes
- bipolar disorder
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- pulmonary disease (including current asthma)
- Parkinson's disease
- Seizure disorder
- unstable thyroid disease
- immune disorder (such as HIV/AIDS)
- active psychiatric disorders (including anxiety disorders)
- bleeding disorders
- gastrointestinal ulcer disease
- any medical condition deemed exclusionary by the Principal Investigator (PI)
- Subject has any orthopedic problem(s) or history of musculoskeletal injury(ies) which make(s) resistance weight training contraindicated.
- Subject has a history of cancer (except localized skin cancer without metastases) within 5 years prior to screening.
- No prescription or chronic medication use allowed without PI discretion.
- Subject is currently taking and unwilling to refrain from taking any over-the-counter stimulant medications/supplements (see section 2.6.2); seven-day washout required for study inclusion.
- Subject is currently taking and unwilling to refrain from taking any over-the-counter allergy or asthma medication containing pseudoephedrine or ephedrine (see section 2.6.2); seven-day washout required for study inclusion.
- Subject has an allergy to milk and phenylalanine, or any of the ingredients in the test product (see section 3.2.1).
- Subject reports sensitivity to caffeine and/or beta-alanine.
- Subject reports being a regular caffeine consumer defined as consuming > 600 mg of caffeine per day.
- Subject exhibits evidence of hepatic or renal dysfunction as evidenced by ALT, AST, AP being ≥ two times the upper limit of normal or serum creatinine value ≥ 2.0 mg/dl or other clinically significant abnormal clinical laboratory value per PI discretion.
- Subject has a clinically relevant abnormality as defined by the PI or interpreting physician with respect to the ECG.
- Subject has a QTcB interval > 450 msec.
- Subject has a history of drug or alcohol abuse in the past 12 months.
- Subject has any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data.
- Subject has taken an investigational product within 30 days of the first exercise test visit (visit 2).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Crossover Clinical Trial Comparing the Effects of Four Pre-Workout Beverages on Muscular Strength and Endurance and Cognitive Performance in Healthy Adult Males
The purpose of this study is to determine the effects of four different pre-workout beverages as compared to placebo on muscular strength and endurance, perceived energy and cognitive performance in healthy adult males.
- Conditions
- Healthy
- Being tested
- Master Performance Blend Dose 1, Master Performance Blend Dose 2, Performance Energy Blend, Energy Blend, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Master Performance Blend Dose 1Dietary supplement
Caffeine content: 200 mg
Master Performance Blend Dose 2Dietary supplement
Caffeine content: 400 mg
Performance Energy BlendDietary supplement
Caffeine content: 175 mg
Energy BlendDietary supplement
Caffeine content: 200 mg
PlaceboDietary supplement
Caffeine content: 0 mg
| Study group | Role | What they receive |
|---|---|---|
| Beverage A | Active comparator | Single dose, Pre-Workout Master Performance Blend Dose 1 Receives: Dietary Supplement: Master Performance Blend Dose 1 |
| Beverage B | Active comparator | Single dose, Pre-Workout Master Performance Blend Dose 2 Receives: Dietary Supplement: Master Performance Blend Dose 2 |
| Beverage C | Active comparator | Single dose, Pre-Workout Performance Energy Blend Receives: Dietary Supplement: Performance Energy Blend |
| Beverage D | Active comparator | Single dose, Pre-Workout Energy Blend Receives: Dietary Supplement: Energy Blend |
| Beverage E | Placebo comparator | Single dose, Pre-Workout Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscular Strength and Endurance compared to Placebo
Muscular Strength and Endurance will be measured by Bench Press and Leg Press 1-RM and repetitions to exhaustion.
Measured: One day
Secondary outcomes (1)
Change from Baseline in Cognitive Performance
Cognitive performance will be measured by the automated trail maker tests A and B.
Measured: Baseline to one-hour post dose and immediately post exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miami Research Associates
- Sponsor type
- Research network
- Collaborators
- Glanbia Performance Nutrition
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255201
- Sponsor's protocol ID
- GPN-2014
- Status last verified
- Apr 2015
- First submitted
- 26 Sep 2014
- Last updated
- 7 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Crossover Clinical Trial Comparing the Effects of Four Pre-Workout Beverages on Muscular Strength and Endurance and Cognitive Performance in Healthy Adult Males
- ClinicalTrials.gov ID
- NCT02255201
- Acronym / sponsor ID
- GPN-2014
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Miami Research AssociatesResearch network
- Collaborators
- Glanbia Performance Nutrition
- Study start
- Oct 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 2 Oct 2014 (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.
The purpose of this study is to determine the effects of four different pre-workout beverages as compared to placebo on muscular strength and endurance, perceived energy and cognitive performance in healthy adult males.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Beverage A | Active comparator | Dietary Supplement: Master Performance Blend Dose 1Single dose, Pre-Workout Master Performance Blend Dose 1 |
| Beverage B | Active comparator | Dietary Supplement: Master Performance Blend Dose 2Single dose, Pre-Workout Master Performance Blend Dose 2 |
| Beverage C | Active comparator | Dietary Supplement: Performance Energy BlendSingle dose, Pre-Workout Performance Energy Blend |
| Beverage D | Active comparator | Dietary Supplement: Energy BlendSingle dose, Pre-Workout Energy Blend |
| Beverage E | Placebo comparator | Dietary Supplement: PlaceboSingle dose, Pre-Workout Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Males, aged 18 to 40 years
- Subject has a waist circumference ≤ 97 cm.
- Subject is a non-smoker.
- Subject is in good health and appropriate for exercise as determined by physical examination, medical history and ECG.
- Subject is weight training for the 6 months prior to starting the trial.
Key exclusion criteria (29 listed)
- Subject has any of the following medical conditions:
- Subject has any orthopedic problem(s) or history of musculoskeletal injury(ies) which make(s) resistance weight training contraindicated.
- Subject has a history of cancer (except localized skin cancer without metastases) within 5 years prior to screening.
- No prescription or chronic medication use allowed without PI discretion.
- Subject is currently taking and unwilling to refrain from taking any over-the-counter stimulant medications/supplements (see section 2.6.2); seven-day washout required for study inclusion.
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 |
|---|---|---|
| Master Performance Blend Dose 1Caffeine content: 200 mg | Dietary supplement | Beverage A |
| Master Performance Blend Dose 2Caffeine content: 400 mg | Dietary supplement | Beverage B |
| Performance Energy BlendCaffeine content: 175 mg | Dietary supplement | Beverage C |
| Energy BlendCaffeine content: 200 mg | Dietary supplement | Beverage D |
| PlaceboCaffeine content: 0 mg | Dietary supplement | Beverage E |
Primary outcome
Change in Muscular Strength and Endurance compared to Placebo
Time frame: One day
Muscular Strength and Endurance will be measured by Bench Press and Leg Press 1-RM and repetitions to exhaustion.
1 secondary outcome
Change from Baseline in Cognitive Performance
Time frame: Baseline to one-hour post dose and immediately post exercise
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 7 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Master Performance Blend Dose 1, Master Performance Blend Dose 2 and Performance Energy Blend in people with Healthy, run by Miami Research Associates at 1 site in United States.
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 13 inclusion and 29 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 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in Muscular Strength and Endurance compared to Placebo (time frame: One day). 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 7 Apr 2015.