Pre-Workout on Exercise Performance and Cognition

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:

• 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.

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
• Type I or II diabetes
• bipolar disorder
• 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).