Pre-Workout on Exercise Performance and Cognition
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 Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33143
- Miami Research Associates
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Beverage A
Single dose, Pre-Workout Master Performance Blend Dose 1
|
Caffeine content: 200 mg
|
|
Active Comparator: Beverage B
Single dose, Pre-Workout Master Performance Blend Dose 2
|
Caffeine content: 400 mg
|
|
Active Comparator: Beverage C
Single dose, Pre-Workout Performance Energy Blend
|
Caffeine content: 175 mg
|
|
Active Comparator: Beverage D
Single dose, Pre-Workout Energy Blend
|
Caffeine content: 200 mg
|
|
Placebo Comparator: Beverage E
Single dose, Pre-Workout Placebo
|
Caffeine content: 0 mg
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Muscular Strength and Endurance compared to Placebo
Time Frame: One day
|
Muscular Strength and Endurance will be measured by Bench Press and Leg Press 1-RM and repetitions to exhaustion.
|
One day
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Cognitive Performance
Time Frame: Baseline to one-hour post dose and immediately post exercise
|
Cognitive performance will be measured by the automated trail maker tests A and B.
|
Baseline to one-hour post dose and immediately post exercise
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Perceived Energy and Fatigue
Time Frame: Baseline to one-hour post dose and immediately post exercise
|
Perceived Energy and Fatigue will be measured by the Profile of Mood States.
|
Baseline to one-hour post dose and immediately post exercise
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Estimate)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- GPN-2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
NCT06818032RecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokers
-
NCT07232121RecruitingHealthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult Male
-
NCT07197047CompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | Stretching
-
NCT05361343RecruitingHealthy Aging | Healthy Diet | Healthy Lifestyle
-
NCT05218980Not yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | Cholesterol
-
NCT07515417Active, not recruitingHealthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality
-
NCT03278535CompletedHealthy Volunteers | Healthy Subjects | Healthy Adults
-
NCT07520474CompletedHealthy Participants | Healthy Adult Participants | Healthy Young Adults
-
NCT07597928Not yet recruiting
-
NCT07285122RecruitingHealthy | Healthy Smoker
Clinical Trials on Master Performance Blend Dose 1
-
NCT07514741Enrolling by invitationHealthy Adult Participants
-
NCT02366156Completed
-
NCT02778581UnknownAlzheimer Disease | Cognitive Impairments
-
NCT02847962CompletedAnemia, Iron-Deficiency | Deficiency, Vitamin A
-
NCT01224743Completed
-
NCT04448860Recruiting
-
NCT04228757Unknown
-
NCT04157686CompletedLateral Canthal Lines | Glabellar Lines