HealthyNCT04539054
Pre-workout Supplement Versus Caffeine on Energy Expenditure.
A study testing ENGN Shred, Nutricost caffeine powder and Crystal Light in people with Healthy, run by Northern Illinois University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ENGN Shred, Nutricost caffeine powder and Crystal Light
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 31 Dec 2019
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise Physiology Laboratory
DeKalb, Illinois, 60115
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- ENGN Shred, Nutricost caffeine powder, Crystal Light
- Keywords
- supplementation, ergogenic aid, metabolic rate, energy, substrate utilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENGN ShredDietary supplement
ENGN Shred is a multi-ingredient pre-workout supplement.
Nutricost caffeine powderDietary supplement
Caffeine powder.
Crystal LightDietary supplement
Non-caloric Crystal Light matched for the pre-workout in terms of flavor and consistency.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Workout Condition | Experimental | This condition consisted of the ingestion of one serving of the pre-workout supplement. Receives: Dietary Supplement: ENGN Shred |
| Caffeine Condition | Experimental | This condition consisted of the ingestion of 6 mg of caffeine per kg of body mass. Receives: Dietary Supplement: Nutricost caffeine powder |
| Placebo condition | Placebo comparator | This condition consisted of the ingestion of a placebo. Receives: Dietary Supplement: Crystal Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure
Measurement of caloric expenditure via gas exchange
Measured: Measured continuously during 60 minutes of exercise for all three supplement conditions
Secondary outcomes (9)
Oxygen consumption
Measurement of rate of oxygen consumption using a metabolic cart
Measured: Measured continuously during 60 minutes of exercise for all three supplement conditions
Carbon dioxide production
Measurement of rate of carbon dioxide production using a metabolic cart
Measured: Measured continuously during 60 minutes of exercise for all three supplement conditions
Minute ventilation
Measurement of ventilation rate using a metabolic cart
Measured: Measured continuously during 60 minutes of exercise for all three supplement conditions
Feelings of fatigue
Subjects were asked to rate their feelings of fatigue using a 5-point Likert scale
Measured: Baseline, 30-minutes post-ingestion of supplement, and at the 30-minute time point of exercise for all three supplement conditions
Feelings of energy
Subjects were asked to rate their feelings of energy using a 5-point Likert scale
Measured: Baseline, 30-minutes post-ingestion of supplement, and at the 30-minute time point of exercise for all three supplement conditions
Feelings of focus
Subjects were asked to rate their feelings of focus using a 5-point Likert scale
Measured: Baseline, 30-minutes post-ingestion of supplement, and at the 30-minute time point of exercise for all three supplement conditions
Feelings of alertness
Subjects were asked to rate their feelings of focus using a 5-point Likert scale
Measured: 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
Fat oxidation was estimated thru measurements of gas exchange
Measured: Measured continuously during 60 minutes of exercise for all three supplement conditions
Rate of carbohydrate oxidation
Carbohydrate oxidation was estimated thru measurements of gas exchange
Measured: Measured continuously during 60 minutes of exercise for all three supplement conditions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start1 Sep 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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
- Treatment
- 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
- Responsible party
- Principal investigator, Clayton Camic, Northern Illinois University
- Investigators
- Clayton L Camic, PhD, Principal investigator, Northern Illinois University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539054
- Sponsor's protocol ID
- HS19-0163
- Status last verified
- Aug 2020
- First submitted
- 26 Aug 2020
- Last updated
- 4 Sep 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 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04539054
- Acronym / sponsor ID
- HS19-0163
- Conditions
- Healthy
- Keywords
- supplementation, ergogenic aid, metabolic rate, energy, substrate utilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Northern Illinois UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 4 Sep 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-Workout Condition | Experimental | Dietary Supplement: ENGN ShredThis condition consisted of the ingestion of one serving of the pre-workout supplement. |
| Caffeine Condition | Experimental | Dietary Supplement: Nutricost caffeine powderThis condition consisted of the ingestion of 6 mg of caffeine per kg of body mass. |
| Placebo condition | Placebo comparator | Dietary Supplement: Crystal LightThis condition consisted of the ingestion of a placebo. |
Who may qualify
- Ages
- 19 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| ENGN ShredENGN Shred is a multi-ingredient pre-workout supplement. | Dietary supplement | Pre-Workout Condition |
| Nutricost caffeine powderCaffeine powder. | Dietary supplement | Caffeine Condition |
| Crystal LightNon-caloric Crystal Light matched for the pre-workout in terms of flavor and consistency. | Dietary supplement | Placebo condition |
Primary outcome
Energy expenditure
Time frame: Measured continuously during 60 minutes of exercise for all three supplement conditions
Measurement of caloric expenditure via gas exchange
9 secondary outcomes
Oxygen consumption
Time frame: 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
Minute ventilation
Time frame: 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
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
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
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
Rate of fat oxidation
Time frame: 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
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 4 Sep 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 L Camic, PhD principal investigator
Northern Illinois University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENGN Shred, Nutricost caffeine powder and Crystal Light in people with Healthy, run by Northern Illinois University at 1 site in United States.
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 5 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 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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: Measured continuously during 60 minutes of exercise for all three supplement conditions). 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 4 Sep 2020.