Energy MetabolismNCT03678116
Effects of a Thermogenic Dietary Supplement on Metabolic, Hemodynamic, and Mood Responses
A study testing Caffeine (plus Teacrine and Cayenne) and Caffeine (plus Teacrine) in people with Energy Metabolism and Heart Rate, run by University of Mary Hardin-Baylor at 1 site in United States.
Trial summary
This a randomized, double blind, placebo controlled, crossover design study which measures the effect of an available thermogenic dietary supplement on resting energy expenditure (REE), blood pressure and heart rate, and mood changes in moderate caffeine consumers. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Metabolism, Heart Rate, Blood Pressure
- What is being tested?
- Caffeine (plus Teacrine and Cayenne) and Caffeine (plus Teacrine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2018to 31 Oct 2018
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will be male or female between the ages of 18-35 years
- Subjects will not consume caffeine 24 hours prior to testing
- Subjects will be daily caffeine consumers (<200mg/day prior to 12pm)
- Subject has provided written and dated informed consent to participate in the study
- Subject is willing and able to comply with the protocol
- Subject is apparently healthy and free from disease, as determined by a health history questionnaire
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- Subject agrees to log their diet 48 hours prior to each testing session
- Subject agrees to abstain from exercise 24 hours prior to each testing visit
- Subject agrees to fast for 12 hours prior to each testing visit
- Subject agrees to refrain from sleeping for one hour prior to and during each testing session
Who cannot join
- Subject has sensitivity issues following ingestion of caffeine
- Subject currently smokes or has quit within the last 6 months
- Subject takes medication prescribed by a physician or regularly takes over the counter medication
- Subject is allergic to any ingredient in the nutritional supplement or placebo
- Subject may be pregnant, is pregnant, is trying to become pregnant, or is breastfeeding
- Subject reports any unusual adverse events associated with this study that in consultation with the study investigators or their doctor recommends removal from the study
- Subject consumes >200 mg of caffeine before 12pm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on REE, Cardiovascular, and Mood Responses
This a randomized, double blind, placebo controlled, crossover design study which measures the effect of an available thermogenic dietary supplement on resting energy expenditure (REE), blood pressure and heart rate, and mood changes in moderate caffeine consumers. Participants will complete baseline measurements then ingest one of three pills. Once the pill is ingested, subjects will complete four REEs along with heart rate and blood pressure and appropriate questionnaires. Participants will return two more times, each after a one week washout period, and complete the same protocol with the remaining supplements.
Read the detailed description
Subjects expressing interest in completing the study will be interviewed in the UMHB Human Performance Lab (HPL) to determine whether they qualify to participate in the study. Upon qualification, participants will be scheduled for their first testing session which will include: a body composition analysis via an InBody 770, hunger questionnaires, VAS questionnaires, follow up questionnaire, and 5 resting energy expenditure (REE) tests. Participants will be randomized into an order that determines which supplement to ingest at their testing sessions. Example: A, C, B will correspond to taking A the first session, C the second session and so on.
Supplementation protocol: Participants will be randomized into an order that determines which supplement to ingest at their testing sessions. Example: A, C, B will correspond to taking A the first session, C the second session and so on. Subjects will take one pill with 8oz of water in one minute of allotted time.
After initial REE, heart rate, blood pressure, questionnaires, and body composition tests, subjects will ingest the first of three supplements. After ingestion, subjects will complete four REEs every hour. At initial and 60 minutes post ingestion, ECG measurements will be recorded using the Biopac BSL. After each REE is complete, heart rate, blood pressure, and questionnaires will be taken and recorded. The REE will last 20 minutes, thus to ensure ending time is at the hour mark, the REE will be started at the 40 minute time point. Once testing is finished, subjects will return to the lab two more times with a one week washout period to ingest the remaining supplements.
Two days prior to each of the three testing sessions, participants will record their dietary intake via MyFitnessPal.
- Conditions
- Energy Metabolism, Heart Rate, Blood Pressure, Mood
- Being tested
- Sugar Pill (placebo), Caffeine (plus Teacrine and Cayenne), Caffeine (plus Teacrine)
- Keywords
- caffeine, metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar Pill (placebo)Drug
Taken orally in capsule form
Caffeine (plus Teacrine and Cayenne)Dietary supplement
Taken orally in capsule form
Caffeine (plus Teacrine)Dietary supplement
Taken orally in capsule form
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill (Placebo) | Placebo comparator | Taken with 8oz of water after baseline REE and hemodynamic measurements have been taken. One of three interventions to be consumed by the subjects. One week washout period required between treatments. Receives: Drug: Sugar Pill (placebo) |
| Caffeine (plus Teacrine and Cayenne) | Experimental | Taken with 8oz of water after baseline REE and hemodynamic measurements have been taken. One of three interventions to be consumed by the subjects. One week washout period required between treatments. Receives: Dietary Supplement: Caffeine (plus Teacrine and Cayenne) |
| Caffeine (plus Teacrine) | Experimental | Taken with 8oz of water after baseline REE and hemodynamic measurements have been taken. One of three interventions to be consumed by the subjects. One week washout period required between treatments. Receives: Dietary Supplement: Caffeine (plus Teacrine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Resting Energy Expenditure (REE)
The primary purpose of this investigation is to determine the effectiveness of commercially available thermogenic dietary supplement on changing caloric expenditure via resting energy expenditure (REE) in daily, but modest caffeine consumers. This will be accomplished by observing caloric expenditure over a four hour time period post ingestion of the supplement as compared to baseline caloric expenditure pre-supplementation.
Measured: REE completed every hour for four hours post ingestion
Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Heart Rate
The primary purpose of this investigation is to determine the effectiveness of commercially available thermogenic dietary supplement on changing heart rate as measured by Omron HEM-907XL professional blood pressure monitor in daily, but modest caffeine consumers. This will be accomplished by observing heart rate over a four hour time period post ingestion of the supplement as compared to baseline heart rate pre-supplementation.
Measured: Heart rate taken every hour for four hours post ingestion
Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Blood Pressure
The primary purpose of this investigation is to determine the effectiveness of commercially available thermogenic dietary supplement on changes in both systolic and diastolic blood pressure as measured by Omron HEM-907XL professional blood pressure monitor in daily, but modest caffeine consumers. This will be accomplished by observing blood pressure over a four hour time period post ingestion of the supplement as compared to baseline blood pressure pre-supplementation.
Measured: Blood pressure taken every hour for four hours post ingestion
Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Mood Responses
The primary purpose of this investigation is to determine the effectiveness of commercially available thermogenic dietary supplement on changes in mood as measured by the Visual Analog Scale (VAS) in daily, but modest caffeine consumers. This will be accomplished by observing changes in mood over a four hour time period post ingestion of the supplement as compared to their baseline mood response pre-supplementation. The VAS measures levels of energy, focus, concentration, alertness, and fatigue.The VAS is used to measure attitudes over a continuum ranging from "lowest possible" to "highest possible". Participants are required to mark a line along a 10 centimeter line with one end titled "lowest possible" and the opposite end titled "highest possible". Scores for the scale range from 0 to 10 with levels of energy, focus, concentration, and alertness being towards the higher end of the scale, closer to 10. Levels of fatigue should be towards the lower end of the scale, closer to 0.
Measured: VAS values recorded every hour for four hours post ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start23 Jul 2018
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy MetabolismStudies 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
- Model description
- Three groups: placebo, caffeine (plus Teacrine and Cayenne) and caffeine (plus Teacrine)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mary Hardin-Baylor
- Sponsor type
- University, hospital or other
- Collaborators
- Dymatize Inc.
- Responsible party
- Sponsor
- Investigators
- Lemuel W Taylor IV, PhD, Principal investigator, UMHB Human Performance Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678116
- Sponsor's protocol ID
- AMP-1
- Status last verified
- Mar 2019
- First submitted
- 11 Sep 2018
- Last updated
- 28 Mar 2019
- 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 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on REE, Cardiovascular, and Mood Responses
- ClinicalTrials.gov ID
- NCT03678116
- Acronym / sponsor ID
- AMP-1
- Conditions
- Energy Metabolism, Heart Rate, Blood Pressure, Mood
- Keywords
- caffeine, metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Mary Hardin-BaylorUniversity, hospital or other
- Collaborators
- Dymatize Inc.
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 19 Sep 2018 (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.
This a randomized, double blind, placebo controlled, crossover design study which measures the effect of an available thermogenic dietary supplement on resting energy expenditure (REE), blood pressure and heart rate, and mood changes in moderate caffeine consumers. Participants will complete baseline measurements then ingest one of three pills. Once the pill is ingested, subjects will complete four REEs along with heart rate and blood pressure and appropriate questionnaires. Participants will return two more times, each after a one week washout period, and complete the same protocol with the remaining supplements.
Detailed description
Subjects expressing interest in completing the study will be interviewed in the UMHB Human Performance Lab (HPL) to determine whether they qualify to participate in the study. Upon qualification, participants will be scheduled for their first testing session which will include: a body composition analysis via an InBody 770, hunger questionnaires, VAS questionnaires, follow up questionnaire, and 5 resting energy expenditure (REE) tests. Participants will be randomized into an order that determines which supplement to ingest at their testing sessions. Example: A, C, B will correspond to taking A the first session, C the second session and so on.
Supplementation protocol: Participants will be randomized into an order that determines which supplement to ingest at their testing sessions. Example: A, C, B will correspond to taking A the first session, C the second session and so on. Subjects will take one pill with 8oz of water in one minute of allotted time.
After initial REE, heart rate, blood pressure, questionnaires, and body composition tests, subjects will ingest the first of three supplements. After ingestion, subjects will complete four REEs every hour. At initial and 60 minutes post ingestion, ECG measurements will be recorded using the Biopac BSL. After each REE is complete, heart rate, blood pressure, and questionnaires will be taken and recorded. The REE will last 20 minutes, thus to ensure ending time is at the hour mark, the REE will be started at the 40 minute time point. Once testing is finished, subjects will return to the lab two more times with a one week washout period to ingest the remaining supplements.
Two days prior to each of the three testing sessions, participants will record their dietary intake via MyFitnessPal.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Three groups: placebo, caffeine (plus Teacrine and Cayenne) and caffeine (plus Teacrine)
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill (Placebo) | Placebo comparator | Drug: Sugar Pill (placebo)Taken with 8oz of water after baseline REE and hemodynamic measurements have been taken. One of three interventions to be consumed by the subjects. One week washout period required between treatments. |
| Caffeine (plus Teacrine and Cayenne) | Experimental | Dietary Supplement: Caffeine (plus Teacrine and Cayenne)Taken with 8oz of water after baseline REE and hemodynamic measurements have been taken. One of three interventions to be consumed by the subjects. One week washout period required between treatments. |
| Caffeine (plus Teacrine) | Experimental | Dietary Supplement: Caffeine (plus Teacrine)Taken with 8oz of water after baseline REE and hemodynamic measurements have been taken. One of three interventions to be consumed by the subjects. One week washout period required between treatments. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subjects will be male or female between the ages of 18-35 years
- Subjects will not consume caffeine 24 hours prior to testing
- Subjects will be daily caffeine consumers (<200mg/day prior to 12pm)
- Subject has provided written and dated informed consent to participate in the study
- Subject is willing and able to comply with the protocol
Key exclusion criteria (7 listed)
- Subject has sensitivity issues following ingestion of caffeine
- Subject currently smokes or has quit within the last 6 months
- Subject takes medication prescribed by a physician or regularly takes over the counter medication
- Subject is allergic to any ingredient in the nutritional supplement or placebo
- Subject may be pregnant, is pregnant, is trying to become pregnant, or is breastfeeding
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 |
|---|---|---|
| Sugar Pill (placebo)Taken orally in capsule form | Drug | Sugar Pill (Placebo) |
| Caffeine (plus Teacrine and Cayenne)Taken orally in capsule form | Dietary supplement | Caffeine (plus Teacrine and Cayenne) |
| Caffeine (plus Teacrine)Taken orally in capsule form | Dietary supplement | Caffeine (plus Teacrine) |
Primary outcome
Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Resting Energy Expenditure (REE)
Time frame: REE completed every hour for four hours post ingestion
The primary purpose of this investigation is to determine the effectiveness of commercially available thermogenic dietary supplement on changing caloric expenditure via resting energy expenditure (REE) in daily, but modest caffeine consumers. This will be accomplished by observing caloric expenditure over a four hour time period post ingestion of the supplement as compared to baseline caloric expenditure pre-supplementation.
Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Heart Rate
Time frame: Heart rate taken every hour for four hours post ingestion
The primary purpose of this investigation is to determine the effectiveness of commercially available thermogenic dietary supplement on changing heart rate as measured by Omron HEM-907XL professional blood pressure monitor in daily, but modest caffeine consumers. This will be accomplished by observing heart rate over a four hour time period post ingestion of the supplement as compared to baseline heart rate pre-supplementation.
Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Blood Pressure
Time frame: Blood pressure taken every hour for four hours post ingestion
The primary purpose of this investigation is to determine the effectiveness of commercially available thermogenic dietary supplement on changes in both systolic and diastolic blood pressure as measured by Omron HEM-907XL professional blood pressure monitor in daily, but modest caffeine consumers. This will be accomplished by observing blood pressure over a four hour time period post ingestion of the supplement as compared to baseline blood pressure pre-supplementation.
Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Mood Responses
Time frame: VAS values recorded every hour for four hours post ingestion
The primary purpose of this investigation is to determine the effectiveness of commercially available thermogenic dietary supplement on changes in mood as measured by the Visual Analog Scale (VAS) in daily, but modest caffeine consumers. This will be accomplished by observing changes in mood over a four hour time period post ingestion of the supplement as compared to their baseline mood response pre-supplementation. The VAS measures levels of energy, focus, concentration, alertness, and fatigue.The VAS is used to measure attitudes over a continuum ranging from "lowest possible" to "highest possible". Participants are required to mark a line along a 10 centimeter line with one end titled "lowest possible" and the opposite end titled "highest possible". Scores for the scale range from 0 to 10 with levels of energy, focus, concentration, and alertness being towards the higher end of the scale, closer to 10. Levels of fatigue should be towards the lower end of the scale, closer to 0.
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 28 Mar 2019.
- 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.
Lemuel W Taylor IV, PhD principal investigator
UMHB Human Performance Lab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine (plus Teacrine and Cayenne) and Caffeine (plus Teacrine) in people with Energy Metabolism and Heart Rate, run by University of Mary Hardin-Baylor 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 10 inclusion and 7 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 28 Mar 2019. 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?
Effects of Ingestion of a Commercially Available Thermogenic Dietary Supplement on Resting Energy Expenditure (REE) (time frame: REE completed every hour for four hours post ingestion). The study lists 4 primary outcomes in all. 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 28 Mar 2019.