- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04352998
Effects of a Multi-Ingredient Pre-Workout Supplement on Energy Expenditure During Running
April 16, 2020 updated by: Clayton Camic, Northern Illinois University
Effects of One Versus Two Doses of a Multi-Ingredient Pre-Workout Supplement on Metabolic Factors and Perceived Exertion During Moderate-Intensity Running in Females
The primary purpose of this study was to examine the acute effects of one versus two doses of a multi-ingredient pre-workout supplement on energy expenditure during moderate-intensity treadmill running.
In addition, our second aim was to investigate the responses of associated metabolic factors (i.e.
substrate utilization, measures of gas exchange), perceived exertion, and resting cardiovascular variables with one and two doses of the pre-workout supplement.
Study Overview
Status
Completed
Conditions
Detailed Description
This study utilized a randomized, double-blind, placebo-controlled, within-subjects crossover design (Figure 1).
Each subject was required to visit the laboratory on five occasions with 72-96 hours between sessions.
During the first laboratory visit, each subject performed an incremental test on a treadmill to familiarize the subjects with the testing procedures.
For the second laboratory visit, each subject performed an incremental treadmill test to exhaustion to determine their ventilatory threshold (VT).
The third laboratory visit was completed in the morning (06:00-09:00) and required subjects to consume a standardized meal after fasting overnight (8 hours) and sat quietly for 30 minutes before baseline heart rate and blood pressure values were recorded.
The subjects were then randomly assigned to ingest the supplement (one or two doses) or placebo and sit quietly for another 30 minutes.
The ingredients of the supplement (Cellucor, Bryan, TX) are provided in Table 1.
The placebo was non-energetic and controlled for similar appearance and taste.
At the 15-minute and 30-minute post-ingestion periods (of the pre-workout supplement or placebo), resting heart rate and blood pressure were recorded for a second and third time, respectively.
Subjects then performed a 30-minute constant-velocity treadmill run at 90% of their VT.
The subjects then returned to the laboratory for their fourth and fifth visits to ingest the remaining substances (1-dose, 2-dose, or placebo) and undergo the same testing procedures (including time of day) as the third visit.
Each subject recorded 2-day food logs (MyFitnessPal, Inc., USA) prior to each laboratory visit.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
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
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- ran ≥ 16 km per week
Exclusion Criteria:
- (i) history of medical or surgical events, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders; (ii) use of any medication; (iii) use of nutritional supplements; (iv) habitual use of caffeine (≥ one cup of coffee or caffeinated beverage per day); or (v) 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: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: One dose pre-workout supplement condition
One dose/serving of a multi-ingredient pre-workout supplement was administered to the subjects.
|
one dose of a multi-ingredient pre-workout supplement
|
Active Comparator: Two dose pre-workout supplement condition
Two doses/servings of a multi-ingredient pre-workout supplement was administered to the subjects.
|
two doses of a multi-ingredient pre-workout supplement
|
Placebo Comparator: Placebo condition
One dose/serving of a placebo was administered to the subjects.
|
one dose of a placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Energy expenditure
Time Frame: 30 minutes of exercise
|
energy expenditure measured as kcals per minute
|
30 minutes of exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
substrate utilization
Time Frame: 30 minutes of exercise
|
fat and carbohydrate oxidation
|
30 minutes of exercise
|
measures of gas exchange
Time Frame: 30 minutes of exercise
|
oxygen consumption, respiratory exchange ratio
|
30 minutes of exercise
|
perceived exertion
Time Frame: 30 minutes of exercise
|
ratings of perceived exertion (RPE)
|
30 minutes of exercise
|
resting cardiovascular variables
Time Frame: baseline and 30 minutes post-ingestion
|
heart rate, systolic and diastolic blood pressure
|
baseline and 30 minutes post-ingestion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Clayton 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)
May 16, 2016
Primary Completion (Actual)
May 16, 2016
Study Completion (Actual)
May 16, 2016
Study Registration Dates
First Submitted
April 16, 2020
First Submitted That Met QC Criteria
April 16, 2020
First Posted (Actual)
April 20, 2020
Study Record Updates
Last Update Posted (Actual)
April 20, 2020
Last Update Submitted That Met QC Criteria
April 16, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- NorthernIU
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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