Effects of Dynamine Ingestion on Various Indices of Sustained Energy

The Center for Applied Health Sciences

Status

Completed

Conditions

Energy

Treatments

Dietary Supplement: Dynamine (methylliberine)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06048640

#CSI-08-2022-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

21 to 55 years old

Volunteers

Accepts Healthy Volunteers

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