Status:
COMPLETED
Pre-Workout on Exercise Performance and Cognition
Lead Sponsor:
Miami Research Associates
Collaborating Sponsors:
Glanbia Performance Nutrition
Conditions:
Healthy
Eligibility:
MALE
18-40 years
Phase:
NA
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 h...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02255201
Start Date
October 1 2014
End Date
January 1 2015
Last Update
April 7 2015
Active Locations (1)
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1
Miami Research Associates
Miami, Florida, United States, 33143