Pre-Workout on Exercise Performance and Cognition

Completed · Not applicable · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID: NCT02255201
Run by: Miami Research Associates
People needed: 24
Starts: 2014-10-01
Expected to finish: 2015-01-01
Last updated by the study team: 2015-04-07

Who can join

Age: 18 and older, up to 40. Sex: male. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Miami Research Associates — Miami, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.