MADRID, June 15, 2021 /PRNewswire/ -- A new randomized, double-blind, placebo-controlled study reveals the positive effects of affron® saffron extract on menopausal symptoms in women during perimenopause. The saffron extract, administered for 12 weeks at 28 mg at day, was associated with greater improvements in psychological symptoms. Affron is produced and marketed by Pharmactive using green proprietary technology to extract pure, highly concentrated saffron.
Perimenopause, a period of hormonal turmoil that hits women usually in their 40s, often comes with a series of symptoms that can last anywhere between a few months to 10 years. For many, it is a particularly distressing life event, especially when occurring at a time the woman is particularly busy and active. This transition often includes a broad spectrum of symptoms, from hot flushes, night sweats, and sleep disturbances to changes in cognitive function, performance, and mood including melancholy and stress. Mood changes are seen as the most clinically disabling event for women at large.
In the two-arm, parallel-group, 12-week, randomized, double-blind, placebo-controlled trial, published in the Journal of Menopausal Medicine, June 2, 2021, healthy perimenopausal women aged between 40-60 experiencing menopausal complaints but without severe hot flushes, were recruited and randomized to receive either a placebo or 28mg of a saffron extract (affron). Results revealed a 33% reduction in stress and a 32% reduction in low mood scores from baseline to week 12. There also was a significantly greater reduction in the negative effects of mood (p=.043) compared to the placebo. However, saffron had no impact on vasomotor symptoms or other somatic symptoms, suggesting affron's capabilities are predominantly active in alleviating the negative stress effects of menopause without influencing hormones. This avoids the some of the problems associated with the estrogenic approach and allows the safe integration of affron with other hormone influencing ingredients.
Saffron has traditionally been used in complaints related to the eye, skin, respiratory, gastrointestinal, and genitourinary tracts; for labor pains; and for its mood-enhancing affects (Hosseinzadeh and Nassiri-Asl, 2013; Javadi et al., 2013). There also is an increasing body of evidence supporting its mood enhancement and relaxation effects in adults (Marx et al., 2019).
"This is the first study of affron examining menopause symptoms in average perimenopausal women," explains Alberto Espinel, Manager of Strategic R&D in Active and Functional Natural Ingredients for Pharmactive. "It opens a new health category in our offering of evidence-based personalized nutrition targeting specific demographics."
The mechanisms associated with the mood enhancement and relaxation effects of saffron have not yet been determined, although it is postulated to be multifactorial. For example, saffron has been demonstrated to influence neurotransmitter activity, mitigate inflammation, regulate hypothalamic-pituitary-adrenal (HPA) axis activity, reduce oxidative stress, boost mitochondrial activity, and improve neuroplasticity (Lopresti and Drummond, 2014).
Affron does not contain estrogenic compounds. The active ingredients—crocins and safranal—are well tolerated and have a proven capacity for helping to control symptoms related to mood health, including, occasional anxiety, stress, sleep disruption, and more.
"These benefits have not been recognized in herbal extracts focused on the balance of estrogens as alternative hormonal therapy replacement," notes Espinel. "This means that in comparison to other botanical extracts that target menopause symptoms, affron doesn't have undesirable estrogenic effects. This is a key advantage for perimenopausal women seeking natural solutions."
Affron is an all-natural, saffron extract (Crocus sativus L.), with the lowest dosage— just 28mg per day — with proven bioavailability and rapid one-hour absorption. This clean-label saffron extract is backed by 7 clinical studies demonstrating its capacity to improve mood, relieve stress and occasional sadness, support relaxation and help enhance sleep.
About Pharmactive Biotech Products, S.L.
Pharmactive Biotech Products, S.L., is a privately-owned company that develops and manufactures differentiated natural ingredients supported by scientific evidence. The company was founded by a group of entrepreneurs led by Jean-Marie Raymond, who developed a breakthrough concept for the traditional Mediterranean plant of saffron. With high standards and dedicated R&D investment, Pharmactive was the first company to introduce saffron extract for mood improvement. Pharmactive partners internationally with universities and research organizations to boost its R&D capabilities and generate new opportunities for its customers.
For more information, contact
SOURCE Pharmactive Biotech Products, S.L.