Pharmactive’s Affron strengthens mood-health portfolio with new clinical results

Recent clinical trial results reinforce the potential of Affron, the saffron extract developed by Pharmactive Biotech Products, to support individuals with mild depressive symptoms. According to the company, the 12-week randomized, double-blind, placebo-controlled study is the most extensive to date for the ingredient and adds significant weight to the body of evidence supporting its role in mental wellness.

The study involved 202 adults between the ages of 18 and 70 who exhibited symptoms consistent with subclinical depression. This condition — though less severe than major depressive disorder — includes experiences of low mood, lack of interest or pleasure, and anxiety. It affects approximately 11% of adults.

Pharmactive Biotech Products highlights that, while often overlooked, subclinical depression can meaningfully impair day-to-day functioning and increase the risk of more serious mental health issues if left unaddressed.

“The mood-enhancing effects of Affron have been regularly and comprehensively investigated,” says Inés Morán, Ph.D., the company’s scientific studies manager. “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.”

Verified efficacy

Published in the Journal of Nutrition, the study involved participants who were randomly assigned to receive either 28 mg of Affron, taken in two daily doses, or a placebo over a three-month period. A saffron flower growing with saffron inside. Affron is an extract derived from the saffron flower (Image Credit: Pharmactive Biotech Products). The participants’ emotional well-being, including levels of depression, anxiety, stress, and sleep quality, was evaluated using validated psychological assessment tools, including the Depression, Anxiety, and Stress Scale.

The results demonstrated that individuals taking Affron experienced meaningful improvements in mood. Seventy-two percent of participants in the Affron group reported a significant reduction in depressive symptoms, compared to 54% in the placebo group. In addition, those taking Affron saw a 53% decrease in low-mood symptoms by the end of the 12-week intervention.

Additionally, the company notes that improvements began to emerge as early as week five, with participants consistently reporting less sadness and lower stress levels.

“There is increasing interest in the use of natural botanicals to help manage mood disorders,” reveals Marina Díez, Ph.D., Pharmactive Biotech Products’ head of research and development and quality control. “We can confirm our Affron saffron extract has surpassed the five million user threshold, which includes teenagers and menopausal women who are especially prone to mood swings.”

Targeted results

The company underscores that, though the general study population did not show major differences in sleep quality between the Affron and placebo groups, further analysis revealed that Affron offered distinct benefits to those who began the trial with more severe sleep issues.

Among this subgroup, the extract led to a 12% reduction in sleep disturbances and a 15% decrease in sleep-related impairment, suggesting the potential for targeted applications among individuals dealing with both low mood and poor sleep. A man rubbing the back of his neck in an office at his desk as if he is stressed. The results show improvement for some people with subclinical depression (Image Credit: Pharmactive Biotech Products).

Affron is derived from the stigmas of the Crocus sativus L. saffron flower. The ingredient has long been used in herbal traditions, and its reputation for enhancing mood and emotional balance has increasingly been confirmed by modern scientific research. According to Pharmactive, its Affron ingredient is one of the most studied saffron extracts on the market with eleven clinical trials.

The company spotlights that its proprietary green extraction technology preserves the potency of Affron’s active compounds, especially lepticrosalides, which are standardized to a minimum of 3.5%. The ingredient also offers the lowest effective dose available at 28 mg per day and boasts rapid absorption within one hour.

Mechanistically, Pharmactive says Affron may work through several complementary pathways. These include modulating neurotransmitters such as serotonin and dopamine, influencing the hypothalamic-pituitary-adrenal axis to reduce the impact of stress, enhancing antioxidant defenses, lowering inflammation, and supporting neuroprotection. These actions likely contribute to its broad efficacy in improving mood and emotional resilience.

Moreover, the company stresses that with this new study reinforcing its benefits and deepening its clinical dossier, Affron offers brand owners and formulators a powerful ingredient backed by science, sustainability, and growing consumer recognition.