Graham Kell1, Amanda Rao2, Gavin Beccaria1, Paul Clayton3, Antonio Manuel Inarejos-García4, Marin Prodanov5. 1. University of Southern Queensland, School of Psychology and Counselling, Toowoomba, Australia. 2. RDC Clinical, Brisbane, Australia. Electronic address: amanda@rdcglobal.com.au. 3. Institute of Food, Brain and Behaviour, Oxford, UK. 4. Pharmactive Biotech Products S.L. Parque Científico de Madrid, Madrid, Spain. 5. Instituto de Investigación en Ciencias de la Alimentación CIAL (CEI CSIC-UAM), C/Nicolás Cabrera, 9, E-28049 Madrid, Spain.
Abstract
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 28mg/day, 22mg/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 28mg/day dose (with a significant difference between 28mg/day and placebo on the POMS Total Mood Disturbance scale, p<0.001, d=-1.10), but no treatment effect at the 22mg/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.
RCT Entities:
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 28mg/day, 22mg/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 28mg/day dose (with a significant difference between 28mg/day and placebo on the POMS Total Mood Disturbance scale, p<0.001, d=-1.10), but no treatment effect at the 22mg/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.
Authors: Kiran Shahbaz; Dennis Chang; Xian Zhou; Mitchell Low; Sai Wang Seto; Chung Guang Li Journal: Front Pharmacol Date: 2022-08-05 Impact factor: 5.988