Clinical trial NCT06048640: Effects of Dynamine Ingestion on Various Indices of Sustained Energy
Official title: Effects of Dynamine Ingestion on Various Indices of Sustained Energy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy
Lead sponsor: The Center for Applied Health Sciences, LLC
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Concentration
timeFrame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
measure: Motivation
timeFrame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
measure: Mood
timeFrame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
measure: Energy
timeFrame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
measure: Sustained Energy
timeFrame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
measure: Well-being
timeFrame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
measure: Cognitive function
timeFrame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
measure: Cognitive flexibility
timeFrame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
measure: Diastolic blood pressure
timeFrame: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Other outcomes:
Locations:
city: Canfield
country: United States
facility: The Center for Applied Health Sciences
state: Ohio
Study officials:
affiliation: The Center for Applied Health Sciences
name: Betsy Raub, RN, BSN
role: PRINCIPAL_INVESTIGATOR
References: