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Saffron Extract Improves Sleep Quality and Mood upon Awakening, and Increases Melatonin Concentrations in Participants with Poor Sleep Quality

Date 01-14-2022
HC# 122131-680
Keywords:
Saffron (Crocus sativus, Iridaceae)
affron®
Sleep Quality

Lopresti AL, Smith SJ, Drummond PD. 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. Sleep Med. October 2021;86:7-18. doi: 10.1016/j.sleep.2021.08.001.

Individuals with insomnia have difficulty falling asleep, awaken often during the night and have trouble going back to sleep, and wake earlier than desired in the morning. Due to its multifaceted pathophysiology, insomnia can be difficult to treat. Findings from recent studies suggest that saffron (Crocus sativus, Iridaceae) supplementation improves sleep quality in adults. These authors conducted a three-arm, parallel-group, randomized, double-blind, placebo-controlled trial to investigate the sleep-enhancing effects of affron® (Pharmactive Biotech Products SL; Madrid, Spain), a standardized saffron extract derived from 100% Spanish saffron stigmas, in adults with poor sleep quality.

Participants were recruited throughout Australia between October and November 2020 by using social media advertisements. Eligible participants were physically healthy, aged 18-70 years, and reported unsatisfactory sleep lasting longer than four weeks. Individuals were excluded if external factors contributed to irregular sleep patterns (i.e.. night shift work, snoring partner, pain, etc.), diagnosed with a serious medical condition, had a history of drug/alcohol use, or were pregnant or breastfeeding.

The active treatment contained 14 mg (low-dose) or 28 mg (high-dose) of saffron product, standardized to more than 3.5% lepticrosalides, a measure of the bioactive compounds in saffron (including safranal and crocin isomers). The placebo tablets contained microcrystalline cellulose and calcium hydrogen phosphate.

All participants took one tablet daily, one hour before bedtime, with or without food, for 28 days. Forty participants were randomly assigned each to the low-dose saffron extract, high-dose saffron extract, and placebo groups. At the end of the study, the participants assigned to the placebo group were offered a free, four-week supply of saffron extract tablets.

The following questionnaires were used as outcome measures: Pittsburg Sleep Diary (PSD), the Restorative Sleep Questionnaire-Weekly Version (RSQ-W), the Insomnia Symptom Questionnaire (ISQ), the Functional Outcomes of Sleep Questionnaire-Short Version (FOSQ-10), and the Profile of Mood States-Abbreviated Version (POMS-A). The participants completed the RSQ-W and POMS-A weekly and the remaining questionnaires at baseline and at the end of the study. They provided saliva samples at baseline and at the end of the study to measure evening concentrations of cortisol and melatonin.

Data from 102 participants were analyzed; 93 participants provided saliva samples. Four participants in the placebo group, 8 in the low-dose treatment group, and 6 in the high-dose treatment group withdrew for the following reasons: 4 lost the questionnaire booklet, 2 had migraines or headaches, 1 had a foot injury, and 11 withdrew for no reported reason.

Compared with baseline, sleep quality as reported on the PSD significantly improved in the low-dose treatment group (P < 0.001) and in the high-dose treatment group (P = 0.001); no significant change was seen in the placebo group. The between-group difference of the sleep quality of the combined treatment groups and the placebo group was significant (P = 0.023). From baseline to the end of the study, mood upon awakening ratings on the PSD decreased, though not significantly, in the placebo group (1.58% decrease) and significantly improved in the low-dose treatment (7.26% increase; P = 0.038) and high-dose treatment (14.42% increase; P = 0.004) groups. Increases in ISQ scores were not significant in the placebo group compared with significant increases in the low-dose treatment (P = 0.003) and high-dose treatment (P < 0.001) groups.

Melatonin concentrations increased significantly during the study in the combined treatment groups (P = 0.036); the changes in the placebo group and in the individual treatment groups were not significant. Decreases in cortisol concentrations during the study were significant in the combined treatment groups (P = 0.040) and in the high- treatment group (P = 0.032) but did not differ significantly from changes in the placebo group.

The overall compliance rate was greater than 80%. No serious adverse effects were reported, and the frequency of adverse effects was similar among the groups.

Among the study's limitations are the use of self-report questionnaires and diaries as outcome measures and the short treatment duration. The recruitment method used may have biased the population toward social media users interested in natural medicine. Because many of the participants were likely perimenopausal or postmenopausal, the results may not apply to other populations. The authors suggest that future studies should be adequately powered to determine the efficacy of saffron products based on age, gender, and duration of sleep problems; include participants with formally diagnosed insomnia; examine the potential mechanisms responsible for saffron extract's sleep-enhancing effects; compare melatonin concentrations with those of healthy sleepers; and examine the effects of other saffron extracts.

In this study, saffron extract supplementation was associated with improved sleep quality ratings and mood upon awakening and increases in evening salivary melatonin concentrations in participants with poor sleep quality.

This study was funded by Pharmactive Biotech Products SL. Author A.I. Lopresti, the managing director of Clinical Research Australia, has received presentation honoraria from nutraceutical companies. Author S.J. Smith is an employee of Clinical Research Australia. Author P.D. Drummond declares no conflicts of interest.

Shari Henson