Large clinical study reveals Affron® brand saffron’s potential as a natural long-term solution to mild depressive symptoms

Madrid — Results from a new, large-scale clinical study demonstrate Pharmactive Biotech Products, S.L.U.’s flagship saffron extract Affron® could help lift the mood in people suffering from mild depressive symptoms. Building on ten previous clinical studies showcasing Affron’s positive effect on mood, stress, and mental wellness, the latest research on more than 200 volunteers marks Pharmactive’s largest and most ambitious study to date. Affron is a highly purified, highly concentrated saffron extract formulated via patent-protected green technology that both maximizes and protects its valuable bioactives.

Subclinical depression is a mild form of depression where an individual experiences some typical symptoms—such as sadness or loss of interest—but does not meet the full diagnostic criteria for major depressive disorder. Mild mood disorders currently affect 11 percent of adults. While not severe, it can significantly impact daily functioning and is considered a risk factor for developing more serious mental health conditions.

Published May 2025 in the Journal of Nutrition, the rigorous, two-arm randomized, double-blind, placebo-controlled clinical trial, led by Adrian Lopresti, PhD, enrolled 202 adults aged 18 to 70 exhibiting subclinical depressive symptoms, such as low mood, loss of interest, or pleasure, and anxiety. The participants were randomly assigned to receive either 28mg of Affron saffron extract divided into two equal daily doses or a placebo over a period of 12 weeks. Their levels of depression, anxiety, stress, and sleep quality were measured using standardized, validated scales.

Majority felt reduced sadness 

A meaningful improvement in depressive symptoms was experienced by an impressive majority of those who received Affron. Specifically, 72 percent of participants in the saffron group showed significant improvement compared to 54 percent in the placebo group. Those on Affron experienced a 53 percent drop in low mood symptoms following the three months of supplementation, as measured by the DASS 21 (Depression, Anxiety, Stress Scale).

Daily mood ratings revealed group differences in mood and stress that significantly favored Affron intake, with improvements emerging as early as five weeks into  supplementation. Participants reported reduced daily feelings of sadness and stress.

While no significant improvement in sleep quality was found between the saffron and placebo groups in the general sample, subgroup analysis revealed an important nuance: Among participants who reported greater sleep disturbances at baseline, Affron supplementation led to a significant improvement. These individuals experienced a 12 percent reduction in sleep disturbance as opposed to eight percent in the placebo group, and a 15 percent reduction in sleep-related impairment. This suggests that Affron could be particularly beneficial for those who contend with sleep problems.

Ancient spice, modern science

Saffron extract is derived from the delicate stigmas of the Crocus sativus L flower. With a centuries-old reputation as a panacea, it has been traditionally valued for its positive impact on vision, mood, digestion, and overall wellness. Modern research illuminates its unique capabilities for alleviating low mood and stress, with more than 20 randomized clinical trials endorsing these effects. Affron has been at the center of a large part of this research, having undergone eleven clinical trials.

“The mood-enhancing effects of Affron have been regularly and comprehensively investigated,” explains Inés Morán, PhD, Scientific Studies Manager at Pharmactive. “However, all of the previous trials involved smaller sample sizes and durations, typically ranging from 40 to 80 people over a period of four to eight weeks in populations with overt mood disorders. This is our most robust trial yet, designed to examine the safety and efficacy of Affron over a longer treatment duration and with a much larger group of volunteers. Based on the findings from previous trials, we projected Affron supplementation could help brighten the spirits in adults experiencing mild mood dips and improve sleep quality, and the results we achieved surpassed our estimation.”

It has been observed that Affron may work through multiple physiological mechanisms. This includes influencing neurotransmitter activity, moderating the stress response through influence on hypothalamus-pituitary-adrenal axis activity, reducing inflammation, increasing antioxidant defenses, and providing neuroprotection.

Pharmactive’s award-winning water-extracted saffron is standardized to at least 3.5 percent Lepticrosalides®, as verified by HPLC. Affron boasts the lowest dose on the current market at 28mg per day and delivers rapid 1-hour absorption. As a home-formulated, clinically backed, and market-leading saffron brand, Affron has been designated the official reference for saffron extracts by the American Botanical Council.

“There is increasing interest in the use of natural botanicals to help manage mood disorders,” reveals Marina Díez, PhD, Head of R&D+QC at Pharmactive. “We can confirm our Affron saffron extract has surpassed the 5 million user threshold, which includes teenagers and menopausal women who are especially prone to mood swings.”

About Pharmactive

Pharmactive Biotech Products is a Madrid-based pioneering biotechnology company that develops and manufactures differentiated natural ingredients supported by science, such as damiana extract, pure saffron extract, and aged garlic. The company’s mission is to make a daily positive and significant impact on people’s health and well-being through premium botanical ingredients backed by scientific studies and approved by ethics committees.