The Center for Applied Health Sciences
Canfield, Ohio, 44406, United States
NCT Number: NCT06048640
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.
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Notify Me21 year–55 year
All sexes
Interventional
Not applicable
Canfield, Ohio, 44406, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dynamine (methylliberine) is a purine alkaloid found in the kucha leaf, and available to consumers as a dietary supplement.
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.
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.
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.
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.
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.
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.
Time frame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Cognitive function as measured by the Stroop Test.
Time frame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Cognitive flexibility as measured by the Trail Making Test.
Time frame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Systolic blood pressure in mm of mercury.
Time frame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Diastolic blood pressure in mm of mercury.
The Center for Applied Health Sciences, LLC
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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