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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 100 mg of placebo (cellulose) |
|
| Active | Active Comparator | 100 mg of Dynamine (methylliberine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamine (methylliberine) | Dietary Supplement | Dynamine (methylliberine) is a purine alkaloid found in the kucha leaf, and available to consumers as a dietary supplement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration | Concentration as measured by a 10 cm visual analogue scale, where higher values represent better concentration. | 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. | 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. | 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. | 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. | 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. | Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline. |
| Cognitive function |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure | Systolic blood pressure in mm of mercury. | Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline. |
| Diastolic blood pressure | Diastolic blood pressure in mm of mercury. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Betsy Raub, RN, BSN | The Center for Applied Health Sciences, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Applied Health Sciences | Canfield | Ohio | 44406 | United States |
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| ID | Term |
|---|---|
| C000711587 | methylliberine |
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Cognitive function as measured by the Stroop Test.
| Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline. |
| Cognitive flexibility | Cognitive flexibility as measured by the Trail Making Test. | Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline. |
| Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline. |