EnergyNCT06048640
Effects of Dynamine Ingestion on Various Indices of Sustained Energy
A study testing Dynamine (methylliberine) in people with Energy, run by The Center for Applied Health Sciences, LLC at 1 site in United States.
Trial summary
This study is a randomized, placebo-controlled, double-blind, within-subject crossover trial of 25 men and women. The objective of this study is to assess the effects of Dynamine (methylliberine) supplementation on overall well-being including energy, sustained energy, mental stamina, focus, concentration, motivation… Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy
- What is being tested?
- Dynamine (methylliberine)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2022to 21 Jul 2023
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- provide voluntary signed and dated informed consent
- in good health as determined by physical examination and medical history
- between the ages of 21 and 55 years
- body mass index (BMI) of 18.5-27 kg•m-2
- agrees to abstain from exercise and alcohol for 24 hours prior to each study visit
- agrees to abstain from coffee and caffeinated beverages for 12 hours prior to each study visit
Show all 9Show fewer
- normotensive (seated, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg
- normal seated, resting heart rate (<90 per minute)
- willing to duplicate their previous 24-hour and fast for 8 hours prior each study visit
Who cannot join
- a history of diabetes or pre-diabetes
- a history of malignancy in the previous 5 years except for non-melanoma skin cancer
- prior gastrointestinal bypass surgery
- known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism
- any chronic inflammatory condition or disease
- a known allergy to any of the ingredients in the supplement or the placebo
Show all 10Show fewer
- currently participating in another research study with an investigational product or have been in another research study in the previous 30 days
- a caffeine intake of three or more cups of coffee or equivalent (>400 mg) per day
- uses corticosteroids or testosterone replacement therapy (ingestion, injection, or transdermal)
- had any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the participant at increased risk of harm if they were to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Applied Health Sciences
Canfield, Ohio, 44406
About this study
This study is a randomized, placebo-controlled, double-blind, within-subject crossover trial of 25 men and women. The objective of this study is to assess the effects of Dynamine (methylliberine) supplementation on overall well-being including energy, sustained energy, mental stamina, focus, concentration, motivation to accomplish difficult tasks, drive, vigor, positive outlook, maintaining a healthy mood, feelings of well-being, and resilience to stress.
Read the detailed description
This study is a randomized, placebo-controlled, double-blind, within-subject crossover trial of 25 men and women. Dynamine (methylliberine) is a caffeine metabolite and purine alkaloid found in the kucha tea leaf. Dynamine has become a popular dietary supplement with consumers due to its neuro-energetic effects. Previous research has shown Dynamine can improve energy, mood and focus without the cardiovascular effects of elevating heart rate or blood pressure.
In this study, participants will attend 5 study visits. During Visit 1, participants will be screened for participation (i.e., medical history, routine blood work, background baseline diet). During Visits 2 and 4, participants will complete baseline testing including subjective questionnaires that assess energy, sustained energy, mental stamina, focus, concentration, motivation to accomplish difficult tasks, drive, vigor, positive outlook, maintaining a healthy mood, feelings of well-being, resilience to stress in addition to completion of a series of an objective neuropsychological test (Stroop test) to assess mental processing, cognitive flexibility, and attention. After three-4- days of supplementation, participants will return for Visit 3 and 5 where they will take a 4th dose of Dynamine or placebo and repeat the testing outlined at previous baseline visits.
- Conditions
- Energy
- Being tested
- Dynamine (methylliberine)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamine (methylliberine)Dietary supplement
Dynamine (methylliberine) is a purine alkaloid found in the kucha leaf, and available to consumers as a dietary supplement.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 100 mg of placebo (cellulose) Receives: Dietary Supplement: Dynamine (methylliberine) |
| Active | Active comparator | 100 mg of Dynamine (methylliberine) Receives: Dietary Supplement: Dynamine (methylliberine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration
Concentration as measured by a 10 cm visual analogue scale, where higher values represent better concentration.
Measured: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Motivation
Motivation as measured by a 10 cm visual analogue scale, where higher values represent greater motivation.
Measured: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Mood
Mood as measured by a 10 cm visual analogue scale, where higher values represent better mood.
Measured: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Energy
Energy as measured by a 10 cm visual analogue scale, where higher values represent increased energy.
Measured: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Sustained Energy
Sustained energy as measured by a 10 cm visual analogue scale, where higher values represent increased sustained energy.
Measured: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Well-being
Well-being as measured by a 10 cm visual analogue scale, where higher values represent improved feelings of well-being.
Measured: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Cognitive function
Cognitive function as measured by the Stroop Test.
Measured: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Cognitive flexibility
Cognitive flexibility as measured by the Trail Making Test.
Measured: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Secondary outcomes (2)
Systolic blood pressure
Systolic blood pressure in mm of mercury.
Measured: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Diastolic blood pressure
Diastolic blood pressure in mm of mercury.
Measured: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start30 Sep 2022
- Primary completion19 Jan 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnergyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Applied Health Sciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Betsy Raub, RN, BSN, Principal investigator, The Center for Applied Health Sciences, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048640
- Sponsor's protocol ID
- #CSI-08-2022-001
- Status last verified
- Sep 2023
- First submitted
- 16 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dynamine Ingestion on Various Indices of Sustained Energy
- ClinicalTrials.gov ID
- NCT06048640
- Acronym / sponsor ID
- #CSI-08-2022-001
- Conditions
- Energy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The Center for Applied Health Sciences, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 21 Sep 2023 (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 study is a randomized, placebo-controlled, double-blind, within-subject crossover trial of 25 men and women. The objective of this study is to assess the effects of Dynamine (methylliberine) supplementation on overall well-being including energy, sustained energy, mental stamina, focus, concentration, motivation to accomplish difficult tasks, drive, vigor, positive outlook, maintaining a healthy mood, feelings of well-being, and resilience to stress.
Detailed description
This study is a randomized, placebo-controlled, double-blind, within-subject crossover trial of 25 men and women. Dynamine (methylliberine) is a caffeine metabolite and purine alkaloid found in the kucha tea leaf. Dynamine has become a popular dietary supplement with consumers due to its neuro-energetic effects. Previous research has shown Dynamine can improve energy, mood and focus without the cardiovascular effects of elevating heart rate or blood pressure.
In this study, participants will attend 5 study visits. During Visit 1, participants will be screened for participation (i.e., medical history, routine blood work, background baseline diet). During Visits 2 and 4, participants will complete baseline testing including subjective questionnaires that assess energy, sustained energy, mental stamina, focus, concentration, motivation to accomplish difficult tasks, drive, vigor, positive outlook, maintaining a healthy mood, feelings of well-being, resilience to stress in addition to completion of a series of an objective neuropsychological test (Stroop test) to assess mental processing, cognitive flexibility, and attention. After three-4- days of supplementation, participants will return for Visit 3 and 5 where they will take a 4th dose of Dynamine or placebo and repeat the testing outlined at previous baseline visits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Dynamine (methylliberine)100 mg of placebo (cellulose) |
| Active | Active comparator | Dietary Supplement: Dynamine (methylliberine)100 mg of Dynamine (methylliberine) |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- provide voluntary signed and dated informed consent
- in good health as determined by physical examination and medical history
- between the ages of 21 and 55 years
- body mass index (BMI) of 18.5-27 kg•m-2
- agrees to abstain from exercise and alcohol for 24 hours prior to each study visit
Key exclusion criteria (10 listed)
- a history of diabetes or pre-diabetes
- a history of malignancy in the previous 5 years except for non-melanoma skin cancer
- prior gastrointestinal bypass surgery
- known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism
- any chronic inflammatory condition or disease
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 |
|---|---|---|
| Dynamine (methylliberine)Dynamine (methylliberine) is a purine alkaloid found in the kucha leaf, and available to consumers as a dietary supplement. | Dietary supplement | Active, Placebo |
Primary outcome
Concentration
Time frame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Concentration as measured by a 10 cm visual analogue scale, where higher values represent better concentration.
Motivation
Time frame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Motivation as measured by a 10 cm visual analogue scale, where higher values represent greater motivation.
Mood
Time frame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Mood as measured by a 10 cm visual analogue scale, where higher values represent better mood.
Energy
Time frame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Energy as measured by a 10 cm visual analogue scale, where higher values represent increased energy.
Sustained Energy
Time frame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Sustained energy as measured by a 10 cm visual analogue scale, where higher values represent increased sustained energy.
Well-being
Time frame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Well-being as measured by a 10 cm visual analogue scale, where higher values represent improved feelings of well-being.
Cognitive function
Time frame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Cognitive function as measured by the Stroop Test.
Cognitive flexibility
Time frame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Cognitive flexibility as measured by the Trail Making Test.
2 secondary outcomes
Systolic blood pressure
Time frame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Diastolic blood pressure
Time frame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
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 22 Sep 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Energy
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Not yet recruitingObservational study
Discovering Determinants of Food Intake by Application of Artificial Intelligence to Complex, High-Dimensional Data
Healthy Volunteer
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
Recruiting
Randomized Prospective Trial on the Cost-Effectiveness of Photon-Counting CT Versus Energy-Integrating Detector CT in Suspected Chronic Coronary Syndrome
Computed Tomography Angiography, Coronary Artery Disease
Not yet recruiting
Efficacy of TECAR Therapy in Plantar Fasciitis
Plantar Fasciitis
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.
Betsy Raub, RN, BSN principal investigator
The Center for Applied Health Sciences, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamine (methylliberine) in people with Energy, run by The Center for Applied Health Sciences, LLC 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 9 inclusion and 10 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 22 Sep 2023. 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?
Concentration (time frame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.). The study lists 8 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 22 Sep 2023.