- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04539054
Pre-workout Supplement Versus Caffeine on Energy Expenditure.
August 31, 2020 updated by: Clayton Camic, Northern Illinois University
Effects of a Multi-ingredient Pre-workout Supplement Versus Caffeine on Energy Expenditure and Feelings of Fatigue During Low-intensity Treadmill Exercise in College-aged Males.
The primary purpose of this study was to examine the acute effects of a multi-ingredient pre-workout supplement versus an ergogenic dose of caffeine (6 mg/kg) on energy expenditure during low-intensity exercise.
The effects of these substances on substrate utilization, gas exchange, and psychological factors were also investigated.
Twelve males (mean ± SD: age = 22.8 ± 2.4 years) completed three bouts of 60-min of treadmill exercise at 4.8-6.4
km/hr on separate days after consuming a pre-workout supplement, 6 mg/kg of caffeine, or placebo in a randomized fashion.
The pre-workout and caffeine supplements resulted in significantly greater energy expenditure (p < 0.001, p = 0.006, respectively), VO2 (p < 0.001, p = 0.007, respectively), VCO2 (p = 0.006, p = 0.049, respectively), and VE (p < 0.001, p = 0.007, respectively), but not rates of fat or carbohydrate oxidation or respiratory exchange ratio compared to placebo (collapsed across condition).
In addition, the pre-workout supplement increased feelings of alertness (p = 0.015) and focus (p = 0.005) 30-minutes post-ingestion and decreased feelings of fatigue (p = 0.014) during exercise compared to placebo (collapsed across condition).
Thus, the pre-workout supplement increased energy expenditure and measures of gas exchange to the same extent as 6 mg/kg of caffeine with concomitant increased feelings of alertness and focus and decreased feelings of fatigue.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
DeKalb, Illinois, United States, 60115
- Exercise Physiology Laboratory
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 29 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male
Exclusion Criteria:
- history of medical or surgical events, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders;
- use of any medications
- use of nutritional supplements
- habitual use of caffeine (≥1 caffeinated beverage per day)
- participation in another clinical trial or investigation of another investigational product within 30 days prior to screening/enrollment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pre-Workout Condition
This condition consisted of the ingestion of one serving of the pre-workout supplement.
|
ENGN Shred is a multi-ingredient pre-workout supplement.
|
Experimental: Caffeine Condition
This condition consisted of the ingestion of 6 mg of caffeine per kg of body mass.
|
Caffeine powder.
|
Placebo Comparator: Placebo condition
This condition consisted of the ingestion of a placebo.
|
Non-caloric Crystal Light matched for the pre-workout in terms of flavor and consistency.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Energy expenditure
Time Frame: Measured continuously during 60 minutes of exercise for all three supplement conditions
|
Measurement of caloric expenditure via gas exchange
|
Measured continuously during 60 minutes of exercise for all three supplement conditions
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxygen consumption
Time Frame: Measured continuously during 60 minutes of exercise for all three supplement conditions
|
Measurement of rate of oxygen consumption using a metabolic cart
|
Measured continuously during 60 minutes of exercise for all three supplement conditions
|
Carbon dioxide production
Time Frame: Measured continuously during 60 minutes of exercise for all three supplement conditions
|
Measurement of rate of carbon dioxide production using a metabolic cart
|
Measured continuously during 60 minutes of exercise for all three supplement conditions
|
Minute ventilation
Time Frame: Measured continuously during 60 minutes of exercise for all three supplement conditions
|
Measurement of ventilation rate using a metabolic cart
|
Measured continuously during 60 minutes of exercise for all three supplement conditions
|
Feelings of fatigue
Time Frame: Baseline, 30-minutes post-ingestion of supplement, and at the 30-minute time point of exercise for all three supplement conditions
|
Subjects were asked to rate their feelings of fatigue using a 5-point Likert scale
|
Baseline, 30-minutes post-ingestion of supplement, and at the 30-minute time point of exercise for all three supplement conditions
|
Feelings of energy
Time Frame: Baseline, 30-minutes post-ingestion of supplement, and at the 30-minute time point of exercise for all three supplement conditions
|
Subjects were asked to rate their feelings of energy using a 5-point Likert scale
|
Baseline, 30-minutes post-ingestion of supplement, and at the 30-minute time point of exercise for all three supplement conditions
|
Feelings of focus
Time Frame: Baseline, 30-minutes post-ingestion of supplement, and at the 30-minute time point of exercise for all three supplement conditions
|
Subjects were asked to rate their feelings of focus using a 5-point Likert scale
|
Baseline, 30-minutes post-ingestion of supplement, and at the 30-minute time point of exercise for all three supplement conditions
|
Feelings of alertness
Time Frame: Baseline, 30-minutes post-ingestion of supplement, and at the 30-minute time point of exercise for all three supplement conditions
|
Subjects were asked to rate their feelings of focus using a 5-point Likert scale
|
Baseline, 30-minutes post-ingestion of supplement, and at the 30-minute time point of exercise for all three supplement conditions
|
Rate of fat oxidation
Time Frame: Measured continuously during 60 minutes of exercise for all three supplement conditions
|
Fat oxidation was estimated thru measurements of gas exchange
|
Measured continuously during 60 minutes of exercise for all three supplement conditions
|
Rate of carbohydrate oxidation
Time Frame: Measured continuously during 60 minutes of exercise for all three supplement conditions
|
Carbohydrate oxidation was estimated thru measurements of gas exchange
|
Measured continuously during 60 minutes of exercise for all three supplement conditions
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Clayton L Camic, PhD, Northern Illinois University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2019
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
August 26, 2020
First Submitted That Met QC Criteria
August 31, 2020
First Posted (Actual)
September 4, 2020
Study Record Updates
Last Update Posted (Actual)
September 4, 2020
Last Update Submitted That Met QC Criteria
August 31, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS19-0163
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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