MADRID, Aug. 31, 2021 /PRNewswire/ -- Results from a new human clinical study demonstrate a significant capacity for Pharmactive's potent all-natural affron® standardized saffron extract to promote restorative sleep. The ingredient showed its effect in a single, low dose taken just one hour before bedtime, making affron a natural ingredient that is very easy to consume. Moreover, the results are the first to suggest a novel mechanism of action for affron on melatonin levels helping to elevate the natural production of 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.
The incidence of poor sleep has been exacerbated by the social, psychological, and physical impact of COVID-19. A survey last spring by the American Academy of Sleep Medicine (AASM) found that 56% of Americans reported an increase in sleep disturbances. Also, since the start of the pandemic they reported transitory problems sleeping in general. The survey revealed that in the 35-44 age group incidence ran as high as 70% affected.
The new, dose-response, double-blind, placebo-controlled, clinical study was conducted by Adrian Lopresti, PhD; Stephen Smith, MA; and Peter Drummond, PhD in Perth, Western Australia and published in the August 2021 issue of the well reputed scientific journal, Sleep Medicine. This study confirms the conclusions of the previous study published in 2020 on sleep quality in persons suffering from poor sleep and offers important novelties.
In this new study, 120 physically healthy male and female adults, aged 18 to 70 years, with self-reported unsatisfactory sleep lasting longer than four weeks were recruited. For 28 days, the randomized participants received either a placebo or different doses of affron one-hour before going to bed. The main goal of the study was to assess affron's ability of improving sleep quality even at low doses.
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 ratings, mood ratings after awakening, the ISQ total score, and ISQ-insomnia classifications. The marked improvement in sleep quality ratings observed were also accompanied with significant improvement in mood ratings even after awakening. This finding may facilitate the adherence to affron supplementation since it allows a rapid action on sleep quality with just one 14mg dose.
Most importantly, the results were the first to reveal increased levels of melatonin in the participants taking affron. Melatonin is well known as a hormone that regulates many biological functions, including sleep, and circadian rhythms. Poor sleep in adults has been associated with low melatonin production.
Affron supplementation was well-tolerated with no reported significant adverse effects or sluggishness, offering a natural support that avoids the effects of other botanicals or concentrated melatonin supplements that could promote daytime tiredness or sleepiness in some people. "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.
With increasing stress and the ongoing trend of occasional sleep difficulties due to the pandemic, consumers are seeking natural supplements and ingredients in their quest to maintain health and balance in their lives. Good sleep is a fundamental part of such balance, and the new study helps confirm that the ancient herbal spice, saffron, in its pure concentrate form affron, can play a significant part in this effort.
Affron is an all-natural, premium saffron extract (Crocus sativus L.), which has been recognized by various international awards as the most clinically validated branded saffron extract worldwide. It is backed by eight human clinical studies that demonstrate its capacity to help improve mood, relieve symptoms associated with stress and occasional sadness, support relaxation, help enhance sleepiness, and improve mood in menopausal women. This clean-label saffron extract counts on proven bioavailability and rapid one-hour absorption.
Pharmactive Biotech Products, S.L.U., is a Madrid-based pioneer biotechnology company that develops and manufactures differentiated natural ingredients, supported by scientific evidence, such as high-quality saffron extract and aged black garlic. Pharmactive makes these innovative ingredients available to other companies in the food supplement, nutraceutical, and pharmaceutical industries for marketing and distribution. The company's goal is to make a daily positive and significant impact on people's health and well-being by offering premium botanical ingredients backed by scientific studies and approved by ethics committees. Pharmactive is ranked as one of the most innovative, high-quality, and green companies in the nutraceutical industry.
For more information, contact:
Pharmactive Biotech Products, S.L.
Eva Criado, Communication Manager
Tel: +34 659 18 8143
 Lopresti AL., Smith SJ., Metse AP., Drummond PD. Effects of saffron on sleep quality in healthy adults with self-reported poor sleep: a randomized, double-blind, placebo-controlled trial. J Clin Sleep Med. 2020;16(6):937-947.
 Almodovar P., Briskey D., Rao A., Prodanov M., and Inarejos-Garcia AM. Bioaccessibility and Pharmacokinetics of a Commercial Saffron (Crocus sativus L.) Extract. Evidence-Based Complementary and Alternative Medicine, vol. 2020; 8. 2020.
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SOURCE Pharmactive Biotech Products, S.L.