affron® a novel saffron extract (Crocus sativus L.) improves mood in healthy adults over 4 weeks in a double-blind, parallel, randomized, placebocontrolled clinical trial

Background In recent years phytotherapy has been explored as a source for alternative treatments for mood disorders. One potential candidate is saffron (Crocus sativus L.), whose main bioactive components are crocins and safranal. Objectives The aim of this study was to investigate the efficacy of affron®, a standardised stigmas extract from Crocus sativus L. for improving mood, stress, anxiety and sleep quality in healthy adults. Methods In this 3 arm study, 128 participants self-reporting low mood but not diagnosed with depression, were given affron® at 28 mg/day, 22 mg/day, or a placebo treatment in a randomized, double-blind, placebo-controlled trial for 4 weeks. Mood was measured at baseline and at the end of the study, using the POMS (primary outcome measure) and PANAS questionnaires, and the DASS-21 scale. Sleep was monitored using Sleep Quality Index (PSQI). Results Analysis indicated a significant decrease in negative mood and symptoms related to stress and anxiety at a 28 mg/day dose (with a significant difference between 28 mg/day and placebo on the POMS Total Mood Disturbance scale, p < 0.001, d = −1.10), but no treatment effect at the 22 mg/day dose. Limitations The main weaknesses of this investigation were found in the self-reporting nature of both the screening and the testing. Conclusions affron® increased mood, reduced anxiety and managed stress without side effects, offering a natural alternative to standard treatments