The study, funded by Pharmactive Biotech Products, is the first to suggest a novel mechanism of action for the standardised saffron extract 'affron' on melatonin levels, concluding that the ingredient helps to elevate the natural production of the sleep hormone melatonin in the body before bedtime. This opens a new possible mechanism of action for affron openly related to sleep, besides its well-known effects on neurotransmitters balance, and its antioxidant and anti-inflammatory properties.
According to a global sleep survey by Koninklijke Philips N.V, only 55% of adults are satisfied with their sleep, and 70% report they are experiencing one or more new sleep challenges since the beginning of the COVID-19 pandemic. The survey also found that 43% of respondents were troubled by waking up during the night, and 37% said the pandemic was negatively impacting their ability to sleep well.
This transitional “COVID-somnia” as many experts have dubbed it, includes occasional “problems falling or staying asleep, sleeping less, experiencing worse quality sleep, and having more disturbing dreams.
The new, three-arm, dose-response, double-blind, placebo-controlled, clinical study, published in 'Sleep Medicine', confirms the conclusions of the previous 'affron' study published in 2020 on sleep quality in persons suffering from poor sleep and offers important new discoveries.
The study involved 120 physically healthy male and female adults, aged 18 to 70 years, with self-reported unsatisfactory sleep lasting longer than four weeks. For 28 days, the randomised participants received either a placebo or different doses of affron (14 or 28 mg) one-hour before going to bed.
Results of the study showed that, compared to the placebo, affron supplementation was associated with greater improvements in the primary outcome measures of sleep quality, mood ratings after awakening, and the Insomnia Symptom Questionnaire (ISQ) total score.
The report states: "Compared to the placebo, participants supplemented with saffron experienced greater improvements in sleep quality ratings (primary outcome measure), mood ratings after awakening, and ISQ total score. Insomnia classifications based on the ISQ also revealed that saffron supplementation was associated with greater reductions in rates of insomnia (24% reduction) compared to the placebo (6% reduction).
"However, there were no significant differences between the saffron and placebo groups in changes in self-reported alertness ratings after awakening, total sleep time, time to sleep onset, number of awakenings after sleep onset, restorative sleep (measured with the RSQ), and quality of life as associated with excessive sleepiness (measured with the FOSQ-10). There were also no between-group differences in mood-related changes as measured by the POMS-A. A comparison of the two doses of saffron (14 mg and 28 mg) demonstrated that sleep-related improvements were similar for the two administered doses."
Interestingly, salivary hormone analysis revealed melatonin concentrations from baseline to day 28 significantly increased in the combined saffron groups. A statistically-significant decrease in cortisol concentrations from baseline to day 28 was also identified in the combined saffron groups but these decreases did not differ significantly from changes in the placebo group.
The researchers conclude that affron supplementation was well-tolerated with no reported significant adverse effects or sluggishness.
“The results also indicate that this pure, clean-label saffron extract plays a role in helping to maintain melatonin levels within their normal ranges and provide further validation of the quick sleep-enhancing effects of affron supplementation in adults with unsatisfactory sleep,” states Lopresti.
Source: Sleep Medicine
Lopresti. A. L., Smith. S. J., and Drummond. P. D
"An investigation into an evening intake of a saffron extract (affron®) on sleep quality, cortisol, and melatonin concentrations in adults with poor sleep: a randomised, double-blind, placebo-controlled, multi-dose study"