Efficacy and Short-Term Safety of L-Theanine in Randomized, Double-Blind, Parallel-Group Study
Judi Quilici Timmcke1,
Lekh R. Juneja2 and
Mahendra P. Kapoor3
1 Research, Q-Tech Services, Inc., Crossville, TN,
2 Research and Development,
3 Research, Taiyo Kagaku Co., Ltd., Yokkaichi, Mie, Japan
ABSTRACT
Premenstrual syndrome is a condition, which occurs in women during reproductive age. It is recognized as a disorder characterized by complaints of recurrent psychological, physical and/or somatic symptoms, which occur before menstruation. A prospective, randomized, double- blind, placebo-based, parallel-group clinical trial at Herb Research Clinic in Bangor, Maine (an independent research facility) with IRB approval was performed on healthy women over a twelve-week period evaluating if the dietary supplement, Suntheanine (isomerically pure L-theanine), had an effect on premenstrual syndrome. A randomization process determined who was assigned to either product or placebo groups and randomization was equal at 1:1. Following standard medical research approaches, various symptoms were combined into categories associated with emotional and physical parameters of premenstrual syndrome. Out of sixty-nine qualifying for the analysis, twenty-one administered with the placebo and twenty-one with 200 mg L-theanine daily completed the study. The efficacy of the L-theanine to help reduce symptoms of premenstrual syndrome is suggested based on this clinical trial. The PMS Categories Two (Irritability, Anger) and Four (Mood Swings, Crying) each reached the level of High Significance at the 3-Month mark with p-values of 0.009 and 0.006 respectively. There were no adverse effects reported.
