Evidence map›Paper›PMID 24090077›Full record

Trial reportBMC pharmacology & toxicology2013

Physiological and pharmacokinetic effects of oral 1,3-dimethylamylamine administration in men.

Brian K Schilling, Kelley G Hammond, Richard J Bloomer, Chaela S Presley, Charles R Yates

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in BMC pharmacology & toxicology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01765933 (Pharmacokinetic and Physiological Effects of Oral DMAA Administration), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01765933 nacompletednot on this map

Pharmacokinetic and Physiological Effects of Oral DMAA Administration

TypeinterventionalSponsorUniversity of MemphisRan2012 to 2012Enrolled8ConditionsOutcomes of Single Oral DoseArmsDMAA
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Brian K SchillingDepartment of Health and Sport Sciences, The University of Memphis, 161 Roane Fieldhouse, 38152 Memphis, TN, USA. bschllng@memphis.edu.
Kelley G Hammond
Richard J Bloomer
Chaela S Presley
Charles R Yates

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background1,3-dimethylamylamine (DMAA) has been a component of dietary supplements and is also used within "party pills," often in conjunction with alcohol and other drugs. Ingestion of higher than recommended doses results in untoward effects including cerebral hemorrhage. To our knowledge, no studies have been conducted to determine both the pharmacokinetic profile and physiologic responses of DMAA.

methodsEight men reported to the lab in the morning following an overnight fast and received a single 25 mg oral dose of DMAA. Blood samples were collected before and through 24 hours post-DMAA ingestion and analyzed for plasma DMAA concentration using high-performance liquid chromatography-mass spectrometry. Resting heart rate, blood pressure, and body temperature was also measured.

resultsOne subject was excluded from the data analysis due to abnormal DMAA levels. Analysis of the remaining seven participants showed DMAA had an oral clearance of 20.02 ± 5 L∙hr⁻¹, an oral volume of distribution of 236 ± 38 L, and terminal half-life of 8.45 ± 1.9 hr. Lag time, the delay in appearance of DMAA in the circulation following extravascular administration, varied among participants but averaged approximately 8 minutes (0.14 ± 0.13 hr). The peak DMAA concentration for all subjects was observed within 3-5 hours following ingestion and was very similar across subjects, with a mean of ~70 ng∙mL⁻¹. Heart rate, blood pressure, and body temperature were largely unaffected by DMAA treatment.

conclusionsThese are the first data to characterize the oral pharmacokinetic profile of DMAA. These findings indicate a consistent pattern of increase across subjects with regards to peak DMAA concentration, with peak values approximately 15-30 times lower than those reported in case studies linking DMAA intake with adverse events. Finally, a single 25 mg dose of DMAA does not meaningfully impact resting heart rate, blood pressure, or body temperature.

trial registrationNCT01765933.

Indexed as

Dietary SupplementsAdministration, OralAdultAminesBlood PressureChromatography, LiquidHeart RateHumansLimit of DetectionMaleTandem Mass SpectrometryTime FactorsTissue DistributionYoung Adult1,3-dimethylamylamineAmines

Identifiers

PMID24090077
PMCPMC3852303

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.