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

Complement Ther Med. 2017 Aug:33:58-64. doi: 10.1016/j.ctim.2017.06.001. Epub 2017 Jun 13.

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.

Keywords: Clinical trial; Depression; Mood disorders; Phytonutrient; Saffron extract.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Affect / drug effects*
  • Aged
  • Anxiety / drug therapy*
  • Carotenoids / pharmacology
  • Carotenoids / therapeutic use
  • Crocus / chemistry*
  • Cyclohexenes / pharmacology
  • Cyclohexenes / therapeutic use
  • Depression / drug therapy*
  • Depressive Disorder / drug therapy
  • Double-Blind Method
  • Female
  • Flowers / chemistry
  • Humans
  • Male
  • Middle Aged
  • Phytotherapy*
  • Plant Extracts / pharmacology
  • Plant Extracts / therapeutic use*
  • Self Report
  • Stress, Psychological / drug therapy*
  • Terpenes / pharmacology
  • Terpenes / therapeutic use
  • Young Adult

Substances

  • Cyclohexenes
  • Plant Extracts
  • Terpenes
  • Carotenoids
  • safranal
  • crocin