title: Safety of TeaCrine®, a non-habituating, naturally-occurring purine alkaloid over eight weeks of continuous use.
abstract: BACKGROUND
  Theacrine (1,3,7,9-tetramethyluric acid) is a purine alkaloid found in certain coffee (Coffea) species, fruits (Cupuacu [Theobroma grandiflorum]), and tea (Camellia assamica, var. kucha) that has anti-inflammatory, analgesic, and neuro-locomotor properties. Recent preliminary research has also reported increased feelings of energy, reduced fatigue, and strong effects on improving focus, concentration, and motivation to exercise. The purpose of this study was to examine the safety and non-habituating effects of TeaCrine®, a nature-identical, chemically equivalent bioactive version of theacrine.
  
  
  METHODS
  Sixty healthy men (mean ± SD age, height, weight: 22.9 ± 4.7 years, 183.5 ± 9.2 cm, 86.5 ± 13.7 kg) and women (22.3 ± 4.5 years, 165.2 ± 12.3 cm, 69.0 ± 17.4 kg) were placed into one of three groups: placebo (PLA, n = 20), 200 mg TeaCrine® (LD, n = 19) or 300 mg Teacrine® (HD, n = 21) and ingested their respective supplement once daily for 8 weeks. Primary outcomes were fasting clinical safety markers (heart rate, blood pressure, lipid profiles, hematologic blood counts, biomarkers of liver/kidney/immune function) and energy, focus, concentration, anxiety, motivation to exercise, and POMS measured prior to daily dosing to ascertain potential tachyphylactic responses and habituation effects. Data were analyzed via two-way (group × time) ANOVAs and statistical significance was accepted at p < 0.05.
  
  
  RESULTS
  All values for clinical safety markers fell within normal limits and no group × time interactions were noted. No evidence of habituation was noted as baseline values for energy, focus, concentration, anxiety, motivation to exercise, and POMS remained stable in all groups across the 8-week study protocol.
  
  
  CONCLUSIONS
  These findings support the clinical safety and non-habituating neuro-energetic effects of TeaCrine® supplementation over 8 weeks of daily use (up to 300 mg/day). Moreover, there was no evidence of a tachyphylactic response that is typical of neuroactive agents such as caffeine and other stimulants.
authors.affiliation: Department of Exercise and Sport Science, Human Performance Lab & Exercise Biochemistry Lab, University of Mary Hardin-Baylor, Belton, TX USA.
authors.forename: Lem
authors.initials: L
authors.lastname: Taylor
authors.affiliation: School of Kinesiology, Auburn University, Auburn, AL USA.
authors.forename: Petey
authors.initials: P
authors.lastname: Mumford
authors.affiliation: School of Kinesiology, Auburn University, Auburn, AL USA.
authors.forename: Mike
authors.initials: M
authors.lastname: Roberts
authors.affiliation: Department of Exercise and Sport Science, Human Performance Lab & Exercise Biochemistry Lab, University of Mary Hardin-Baylor, Belton, TX USA.
authors.forename: Sara
authors.initials: S
authors.lastname: Hayward
authors.affiliation: Department of Exercise and Sport Science, Human Performance Lab & Exercise Biochemistry Lab, University of Mary Hardin-Baylor, Belton, TX USA.
authors.forename: Jacy
authors.initials: J
authors.lastname: Mullins
authors.affiliation: Department of Exercise and Sport Science, Human Performance Lab & Exercise Biochemistry Lab, University of Mary Hardin-Baylor, Belton, TX USA.
authors.forename: Stacie
authors.initials: S
authors.lastname: Urbina
authors.affiliation: Department of Exercise and Sport Science, Human Performance Lab & Exercise Biochemistry Lab, University of Mary Hardin-Baylor, Belton, TX USA.
authors.forename: Colin
authors.initials: C
authors.lastname: Wilborn
mesh_terms: D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000494:pharmacology; D001794:Blood Pressure / Q000187:drug effects; D028244:Camellia / Q000737:chemistry; D003069:Coffee / Q000737:chemistry; D003071:Cognition / Q000187:drug effects; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D009043:Motor Activity / Q000187:drug effects; D010936:Plant Extracts / Q000008:administration & dosage* / Q000494:pharmacology; D018515:Plant Leaves / Q000737:chemistry*; D016896:Treatment Outcome; D014527:Uric Acid / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000737:chemistry / Q000494:pharmacology
chemical_list: D000893:Anti-Inflammatory Agents; D003069:Coffee; D010936:Plant Extracts; D014527:Uric Acid; C077059:1,3,7,9-tetramethyluric acid
keywords: Habituation; Safety; Theacrine