According to researchers from Australia who conducted the clinical study, four weeks of saffron supplement (28mg) was associated with improvements in insomnia, sleep quality and restorative sleep in healthy adults with self-reported poor sleep.
Results from population-based surveys in Australia and other developed countries indicated that 10 to 45% of adults report poor sleep (regular difficulty either falling or staying asleep).
According to Pharmactive, poor sleep quality is known to pose significant health implications such as increased risk of all-cause mortality.
Julia Diaz, head of marketing at Pharmactive said: “Sleep disorder is a problem pervasive across all age groups, yet consumers are increasingly turning to natural botanicals for relief.”
While the efficacy of herbal medicines as a natural sleep-enhancing agent is limited, Diaz told NutraIngredients-Asia: “This study consolidates the evidence of affron supporting sleep quality and related it for the very first time to the improvement of the quality of life. It is actually considered one on the best designed clinical studies assessing sleep quality in herbal food supplements.”
The findings were published in the Journal of Clinical Sleep Medicine.
Study design
A total of 55 healthy adults aged 18 to 70 from Perth, Western Australia, participated in this study.
They had self-reported sleep problems, and were randomised to receive either saffron extract (affron) or a placebo. All participants were instructed to take one tablet (14mg), twice daily, with or without food for 28 days.
Affron is a standardised saffron extract derived from the stigmas of Crocus sativus L. flower and contain more than 3.5% Lepticrosalides, which are the bioactive compounds (safranal, crocin isomers) found in saffron.
The placebo tablets contained the same excipients as the active tablet (microcrystalline cellulose and calcium hydrogen phosphate).
Pharmactive’s saffron is grown in and manufactured at their extraction plant in Spain. All tablets were manufactured and packed in an Australian Therapeutic Goods Administration registered plant.
Researchers used the Insomnia Severity Index (ISI) as a primary outcome measure, and data was collected at baseline (days -5 to -3), 7, 14, 21, and 28.
Researchers also collected data based on the Restorative Sleep Questionnaire (RSQ) and Pittsburgh Sleep Diary (PSD) on days -1, 0, 3, 7, 14, 27, and 28. The PSD records information on sleep quality, alertness, and awakenings.
Improved sleep quality
The saffron group reported significantly greater improvements in ISI total score (p=0.017), RSQ total score (p=0.029), and PSD sleep quality ratings (p=0.014) than the placebo group.
Overall insomnia was reduced by 25%, and subjects reported less difficulty falling asleep as well as more continuous and less interrupted slumber.
Based on the sleep diary recordings, participants expressed feeling more refreshed and alert upon awakening, enhancing overall quality of life.
It should be noted that even though saffron was associated with greater improvements in sleep quality compared to the placebo, borderline insomnia (mean ISI score of 11.7) persisted at the end of the 28-day intervention. An absence of insomnia on the ISI is a score of 7 or less whereas a score of 15 or more represents moderate or severe insomnia.
Strengths and limitations
While the findings from this study showed that saffron intake was associated with improvements in sleep quality in adults with self-reported sleep complaints, the study had several limitations.
“The recruited sample comprised a population with a mild severity of sleep problems (ISI score < 21) so the efficacy of saffron in people with a greater severity of insomnia is unknown,
“Most participants also were female (87%), and peri- or post-menopausal. So, the applicability of these findings in males, and younger or older females, requires examination in future trials,” researchers said.
In addition, saffron as a spice is subjected to adulteration so the quality of extracts can vary significantly. Researchers said replication using other saffron extracts is essential to assess the generalisability of findings.
They recommended that further studies using larger samples sizes, treatment periods, objective outcome measures, and volunteers with varying demographic and psychographic characteristics are required to replicate and extend these findings.
Diaz told us affron is currently present in Asia-Pacific (Australia, South Korea, Japan), Europe, USA, Canda and North Africa. Besides its sleep improvement benefits, affron is also used in dietary supplement formulations to improve eye health, enhance mood, relieve stress and focus, for targeted populations such as adolescents and kids.
affron is water-soluble and can be used in foods or supplements. It is kosher- and halal-certified, non-GMO, and has a three-year shelf-life.
Source: Journal of Clinical Sleep Medicine
https://doi.org/10.5664/jcsm.8376
“Effects of Saffron on Sleep Quality in Healthy Adults With Self-Reported Poor Sleep: A Randomized, Double-Blind, Placebo-Controlled Trial”
Authors: Adrian L Lopresti, et al.
