Effects of Dynamine Ingestion on Various Indices of Sustained Energy

NCT06048640 | Completed

• 1 other identifier: #CSI-08-2022-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Energy

Outcome Measures

Primary Outcomes (8)

• 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

  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.

Secondary Outcomes (2)

• Systolic blood pressure

  Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.

• Diastolic blood pressure

  Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

100 mg of placebo (cellulose)

Dietary Supplement: Dynamine (methylliberine)

Active

ACTIVE COMPARATOR

100 mg of Dynamine (methylliberine)

Dietary Supplement: Dynamine (methylliberine)

Interventions

Dynamine (methylliberine) DIETARY_SUPPLEMENT

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

Active; Placebo

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Center for Applied Health Sciences, LLC: lead

Study Sites (1)

The Center for Applied Health Sciences

Canfield, Ohio, 44406, United States

Location

MeSH Terms

Interventions

methylliberine

Study Officials

• Betsy Raub, RN, BSN

  The Center for Applied Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2023
• First Posted: September 21, 2023
• Study Start: September 30, 2022
• Primary Completion: January 19, 2023
• Study Completion: July 21, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

US (1)