Effects of Dynamine Ingestion on Various Indices of Sustained Energy

NCT ID: NCT06048640

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2023-07-21

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.

Conditions

Energy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Placebo

100 mg of placebo (cellulose)

Group Type: PLACEBO_COMPARATOR

Dynamine (methylliberine)

Intervention Type: DIETARY_SUPPLEMENT

Dynamine (methylliberine) is a purine alkaloid found in the kucha leaf, and available to consumers as a dietary supplement.

Active

100 mg of Dynamine (methylliberine)

Group Type: ACTIVE_COMPARATOR

Dynamine (methylliberine)

Intervention Type: DIETARY_SUPPLEMENT

Dynamine (methylliberine) is a purine alkaloid found in the kucha leaf, and available to consumers as a dietary supplement.

Interventions

Dynamine (methylliberine)

Dynamine (methylliberine) is a purine alkaloid found in the kucha leaf, and available to consumers as a dietary supplement.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Center for Applied Health Sciences, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Betsy Raub, RN, BSN

Role: PRINCIPAL_INVESTIGATOR

The Center for Applied Health Sciences

Locations

The Center for Applied Health Sciences

Canfield, Ohio, United States

Countries

United States

Other Identifiers

#CSI-08-2022-001

Identifier Type: -

Identifier Source: org_study_id