Clinical trial NCT02255201: Pre-Workout on Exercise Performance and Cognition
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Miami Research Associates
Sponsor class: NETWORK
Collaborators: name: Glanbia Performance Nutrition
First posted: 2014-10-02
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


Eligibility criteria: Inclusion Criteria:

1. Males, aged 18 to 40 years
2. Subject has a waist circumference ≤ 97 cm.
3. Subject is a non-smoker.
4. Subject is in good health and appropriate for exercise as determined by physical examination, medical history and ECG.
5. Subject is weight training for the 6 months prior to starting the trial.
6. 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.
7. Subject agrees to not use any dietary or herbal supplements until after study completion. A 7-day washout is allowed for study inclusion.
8. 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.
9. Subject is able to understand and sign the informed consent to participate in the study.

Exclusion Criteria:

1. 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)
2. Subject has any orthopedic problem(s) or history of musculoskeletal injury(ies) which make(s) resistance weight training contraindicated.
3. Subject has a history of cancer (except localized skin cancer without metastases) within 5 years prior to screening.
4. No prescription or chronic medication use allowed without PI discretion.
5. 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.
6. 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.
7. Subject has an allergy to milk and phenylalanine, or any of the ingredients in the test product (see section 3.2.1).
8. Subject reports sensitivity to caffeine and/or beta-alanine.
9. Subject reports being a regular caffeine consumer defined as consuming \> 600 mg of caffeine per day.
10. 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.
11. Subject has a clinically relevant abnormality as defined by the PI or interpreting physician with respect to the ECG.
12. Subject has a QTcB interval \> 450 msec.
13. Subject has a history of drug or alcohol abuse in the past 12 months.
14. 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.
15. Subject has taken an investigational product within 30 days of the first exercise test visit (visit 2).

Primary outcomes:
measure: Change in Muscular Strength and Endurance compared to Placebo
timeFrame: One day
Secondary outcomes:
measure: Change from Baseline in Cognitive Performance
timeFrame: Baseline to one-hour post dose and immediately post exercise
Other outcomes:
measure: Change from Baseline in Perceived Energy and Fatigue
timeFrame: Baseline to one-hour post dose and immediately post exercise
Locations:
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
Study officials:
References: