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| Name | Class |
|---|---|
| Glanbia Performance Nutrition | UNKNOWN |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beverage A | Active Comparator | Single dose, Pre-Workout Master Performance Blend Dose 1 |
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| Beverage B | Active Comparator | Single dose, Pre-Workout Master Performance Blend Dose 2 |
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| Beverage C | Active Comparator | Single dose, Pre-Workout Performance Energy Blend |
|
| Beverage D | Active Comparator | Single dose, Pre-Workout Energy Blend |
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| Beverage E | Placebo Comparator | Single dose, Pre-Workout Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Master Performance Blend Dose 1 | Dietary Supplement | Caffeine content: 200 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One day |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Cognitive Performance | Cognitive performance will be measured by the automated trail maker tests A and B. | Baseline to one-hour post dose and immediately post exercise |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Perceived Energy and Fatigue | Perceived Energy and Fatigue will be measured by the Profile of Mood States. | Baseline to one-hour post dose and immediately post exercise |
Inclusion Criteria:
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.
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:
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:
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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Research Associates | Miami | Florida | 33143 | United States |
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| Master Performance Blend Dose 2 |
| Dietary Supplement |
Caffeine content: 400 mg |
|
| Performance Energy Blend | Dietary Supplement | Caffeine content: 175 mg |
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| Energy Blend | Dietary Supplement | Caffeine content: 200 mg |
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| Placebo | Dietary Supplement | Caffeine content: 0 mg |
|