Energy Clinical Trial
Official title:
Effects of Dynamine Ingestion on Various Indices of Sustained Energy
Verified date | September 2023 |
Source | The Center for Applied Health Sciences, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | July 21, 2023 |
Est. primary completion date | January 19, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | The Center for Applied Health Sciences | Canfield | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Center for Applied Health Sciences, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | Cognitive function | Cognitive function as measured by the Stroop Test. | Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline. | |
Primary | 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 | Systolic blood pressure | Systolic blood pressure in mm of mercury. | Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline. | |
Secondary | Diastolic blood pressure | Diastolic blood pressure in mm of mercury. | Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline. |
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