HealthyNCT04352998
Effects of a Multi-Ingredient Pre-Workout Supplement on Energy Expenditure During Running
A study testing One dose pre-workout condition and Two dose pre-workout condition in people with Healthy, run by Northern Illinois University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 29 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- One dose pre-workout condition and Two dose pre-workout condition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 16 May 2016to 16 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 29 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ran ≥ 16 km per week
Who cannot join
- (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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- One dose pre-workout condition, Two dose pre-workout condition, Placebo condition
- Keywords
- caffeine, substrate utilization, thermogenic, fat oxidation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One dose pre-workout conditionDietary supplement
one dose of a multi-ingredient pre-workout supplement
Two dose pre-workout conditionDietary supplement
two doses of a multi-ingredient pre-workout supplement
Placebo conditionDietary supplement
one dose of a placebo
| Study group | Role | What they receive |
|---|---|---|
| One dose pre-workout supplement condition | Active comparator | One dose/serving of a multi-ingredient pre-workout supplement was administered to the subjects. Receives: Dietary Supplement: One dose pre-workout condition |
| Two dose pre-workout supplement condition | Active comparator | Two doses/servings of a multi-ingredient pre-workout supplement was administered to the subjects. Receives: Dietary Supplement: Two dose pre-workout condition |
| Placebo condition | Placebo comparator | One dose/serving of a placebo was administered to the subjects. Receives: Dietary Supplement: Placebo condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure
energy expenditure measured as kcals per minute
Measured: 30 minutes of exercise
Secondary outcomes (4)
substrate utilization
fat and carbohydrate oxidation
Measured: 30 minutes of exercise
measures of gas exchange
oxygen consumption, respiratory exchange ratio
Measured: 30 minutes of exercise
perceived exertion
ratings of perceived exertion (RPE)
Measured: 30 minutes of exercise
resting cardiovascular variables
heart rate, systolic and diastolic blood pressure
Measured: baseline and 30 minutes post-ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start16 May 2016
- Primary completion16 May 2016
- Study completion16 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Illinois University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, La Crosse, Mayo Clinic, Nova Southeastern University
- Responsible party
- Principal investigator, Clayton Camic, Northern Illinois University
- Investigators
- Clayton Camic, PHD, Principal investigator, Northern Illinois University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352998
- Sponsor's protocol ID
- NorthernIU
- Status last verified
- Apr 2020
- First submitted
- 16 Apr 2020
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04352998
- Acronym / sponsor ID
- NorthernIU
- Conditions
- Healthy
- Keywords
- caffeine, substrate utilization, thermogenic, fat oxidation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Northern Illinois UniversityUniversity, hospital or other
- Collaborators
- University of Wisconsin, La Crosse, Mayo Clinic, Nova Southeastern University
- Study start
- 16 May 2016 (actual)
- Primary completion
- 16 May 2016 (actual)
- Study completion
- 16 May 2016 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| One dose pre-workout supplement condition | Active comparator | Dietary Supplement: One dose pre-workout conditionOne dose/serving of a multi-ingredient pre-workout supplement was administered to the subjects. |
| Two dose pre-workout supplement condition | Active comparator | Dietary Supplement: Two dose pre-workout conditionTwo doses/servings of a multi-ingredient pre-workout supplement was administered to the subjects. |
| Placebo condition | Placebo comparator | Dietary Supplement: Placebo conditionOne dose/serving of a placebo was administered to the subjects. |
Who may qualify
- Ages
- 19 to 29 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ran ≥ 16 km per week
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One dose pre-workout conditionone dose of a multi-ingredient pre-workout supplement | Dietary supplement | One dose pre-workout supplement condition |
| Two dose pre-workout conditiontwo doses of a multi-ingredient pre-workout supplement | Dietary supplement | Two dose pre-workout supplement condition |
| Placebo conditionone dose of a placebo | Dietary supplement | Placebo condition |
Primary outcome
Energy expenditure
Time frame: 30 minutes of exercise
energy expenditure measured as kcals per minute
4 secondary outcomes
substrate utilization
Time frame: 30 minutes of exercise
measures of gas exchange
Time frame: 30 minutes of exercise
perceived exertion
Time frame: 30 minutes of exercise
resting cardiovascular variables
Time frame: baseline and 30 minutes post-ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clayton Camic, PHD principal investigator
Northern Illinois University
Questions about this trial
What is this clinical trial studying?
A study testing One dose pre-workout condition and Two dose pre-workout condition in people with Healthy, run by Northern Illinois University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy expenditure (time frame: 30 minutes of exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.