Outcomes of Single Oral Dose
Conditions
Keywords
1,3-dimethylamylamine
Brief summary
1,3-dimethylamylamine (DMAA) has become increasingly popular as a component of dietary supplements. It is also used within party pills, often in conjunction with alcohol and other drugs, and has been associated with untoward effects when abused at high dosages. To our knowledge, no studies have been conducted to determine the combined pharmacokinetic profile and physiologic responses of DMAA. To conclude on the safety profile of DMAA based solely on case reports would be problematic, in particular when accepting testimony from patients in uncontrolled environment, potentially under the influence of alcohol and other drugs. This is especially true in light of the fact that no prospective studies have shown these effects. Hence, the intent of the present study was to determine the pharmacokinetic profile of a single 25mg oral dosage of DMAA alone through 24 hours post-ingestion. This represents a typical dosage within one serving of many popular dietary supplements containing DMAA.
Interventions
DIETARY_SUPPLEMENTDMAA
no placebo
Sponsors
University of Tennessee
USP Labs, Inc.
University of Memphis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* must be able to swallow pill
Exclusion criteria
* self-reported cardiovascular or metabolic problems * current smokers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pharmacokinetics | 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hr | The area under the plasma concentration-time curve from time 0 to infinity was calculated using the trapezoidal rule extrapolated to time infinity. The terminal half-life (t 1/2) was calculated using 0.693/Lambda z, with Lambda z as the terminal rate elimination constant. Peak concentration (Cmax), lag time (tlag), time of maximum concentration (tmax), apparent volume of distribution during the terminal elimination phase (Vz/F), and oral clearance (CL/F) were also calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| physiological effects on heart rate and blood pressure | 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hr | heart rate, blood pressure |
Other
| Measure | Time frame | Description |
|---|---|---|
| cutaneous temperature | 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hr | skin temperature |
Countries
United States
Outcome results
None listed