Pre-Workout on Exercise Performance and Cognition
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Beverage A Single dose, Pre-Workout Master Performance Blend Dose 1 |
Dietary Supplement: Master Performance Blend Dose 1
Caffeine content: 200 mg
|
| Active Comparator: Beverage B Single dose, Pre-Workout Master Performance Blend Dose 2 |
Dietary Supplement: Master Performance Blend Dose 2
Caffeine content: 400 mg
|
| Active Comparator: Beverage C Single dose, Pre-Workout Performance Energy Blend |
Dietary Supplement: Performance Energy Blend
Caffeine content: 175 mg
|
| Active Comparator: Beverage D Single dose, Pre-Workout Energy Blend |
Dietary Supplement: Energy Blend
Caffeine content: 200 mg
|
| Placebo Comparator: Beverage E Single dose, Pre-Workout Placebo |
Dietary Supplement: Placebo
Caffeine content: 0 mg
|
Outcome Measures
Primary Outcome Measures
- Change in Muscular Strength and Endurance compared to Placebo [One day]
Muscular Strength and Endurance will be measured by Bench Press and Leg Press 1-RM and repetitions to exhaustion.
Secondary Outcome Measures
- Change from Baseline in Cognitive Performance [Baseline to one-hour post dose and immediately post exercise]
Cognitive performance will be measured by the automated trail maker tests A and B.
Other Outcome Measures
- Change from Baseline in Perceived Energy and Fatigue [Baseline to one-hour post dose and immediately post exercise]
Perceived Energy and Fatigue will be measured by the Profile of Mood States.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Males, aged 18 to 40 years
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Subject has a waist circumference ≤ 97 cm.
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Subject is a non-smoker.
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Subject is in good health and appropriate for exercise as determined by physical examination, medical history and ECG.
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Subject is weight training for the 6 months prior to starting the trial.
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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.
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Subject is willing and able to comply with the protocol including:
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Attending 5 visits each of which is approximately 4 hours long;
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Refraining from caffeine, over-the-counter medications and alcohol for the 24 hours prior to the test visits;
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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;
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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.
Exclusion Criteria:
- Subject has any of the following medical conditions:
-
active heart disease
-
uncontrolled high blood pressure (≥ 140/90 mmHg)
-
renal or hepatic impairment/disease
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Type I or II diabetes
-
bipolar disorder
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pulmonary disease (including current asthma)
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Parkinson's disease
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Seizure disorder
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unstable thyroid disease
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immune disorder (such as HIV/AIDS)
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active psychiatric disorders (including anxiety disorders)
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bleeding disorders
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gastrointestinal ulcer disease
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any medical condition deemed exclusionary by the Principal Investigator (PI)
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Subject has any orthopedic problem(s) or history of musculoskeletal injury(ies) which make(s) resistance weight training contraindicated.
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Subject has a history of cancer (except localized skin cancer without metastases) within 5 years prior to screening.
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No prescription or chronic medication use allowed without PI discretion.
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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.
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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.
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Subject has an allergy to milk and phenylalanine, or any of the ingredients in the test product (see section 3.2.1).
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Subject reports sensitivity to caffeine and/or beta-alanine.
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Subject reports being a regular caffeine consumer defined as consuming > 600 mg of caffeine per day.
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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.
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Subject has a clinically relevant abnormality as defined by the PI or interpreting physician with respect to the ECG.
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Subject has a QTcB interval > 450 msec.
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Subject has a history of drug or alcohol abuse in the past 12 months.
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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.
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Subject has taken an investigational product within 30 days of the first exercise test visit (visit 2).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Miami Research Associates | Miami | Florida | United States | 33143 |
Sponsors and Collaborators
- Miami Research Associates
- Glanbia Performance Nutrition
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GPN-2014