Research

SaffonX Saffron Extract Shown to Support Well-Being/Stress and Remain Stable in Stomach Conditions in Two Separate Studies

The ingredient was evaluated in a human clinical trial on 56 adults, as well as in a pH release study mimicking the conditions of the stomach.

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By: Mike Montemarano

Associate Editor, Nutraceuticals World

Photo: viperagp | Adobe Stock

Two new scientific papers provide evidence that SaffonX, a saffron extract manufactured by Xtractiva Lifescience, can support measures of well-being and stress resilience, and remain stable in stomach conditions to target intestinal release, respectively.

SaffonX is standardized for crocin and safranal content, and is designed to support mood, emotional balance, stress response, and sleep quality. It is standardized to contain at least 11% crocin by UV analysis, and 0.1% safranal by HPLC.

Human Clinical Study

Researchers performed a double-blind, placebo-controlled, human clinical study on 56 adults between the ages of 18 and 65, who reported low mood but were not diagnosed with depression.

Over 56 days of supplementation, participants receiving the saffron formulation experienced statistically significant improvements versus placebo in measures of:

  • Emotions and mood balance (Profile of Mood States)
  • Positive emotional outlook (Positive and Negative Affect Schedule)
  • Perceived stress and emotional resilience (DASS-21)
  • Sleep quality (Pittsburgh Sleep Quality Index)
  • Physiological stress response (blood cortisol)

Benefits became statistically significant starting at day 28 of supplementation, and were sustained through day 56 of the study. The study also confirmed the ingredient was safe and well-tolerated, with no clinically relevant adverse events reported.

Solifuze Delivery Technology Enables Targeted Release

Solifuze is a patented delivery technology that reconstructs a natural matrix using saffron’s native fibers and polysaccharides. The fiber-based matrix entraps the saffron extract, protecting it from the harsh gastric environment, ensuring that it remains intact until it reaches the small intestine.

Once there, exposure to intestinal fluids dissolves the matrix, enabling dispersion of both hydrophilic and hydrophobic constituents. The Solifuze structure provides a controlled, gradual release of the extract, extending its residence time and enhancing its physiological impact.

In the in vitro pH release study, Solifuze technology enabled a controlled release behavior. Under simulated stomach conditions (pH 1.2) for two hours, only 20-30% of the crocin was released, whereas under simulated intestinal conditions (pH 6.8) for the remainder of the five hours, approximately 70% of crocin was released.

The findings suggested that Solifuze helped ensure the actives are protected from and delivered out of the gastric conditions for targeted sustained intestinal release to optimize absorption.

“These results underscore the value of saffron as a well-studied botanical for mood and emotional well-being support, while reinforcing the importance of quality, standardization, and delivery technology,” said Abhijit Natu, vice president of U.S. Nutrition at Maypro, the exclusive U.S. distributor of Xtractiva Lifescience’s botanicals, SaffonX and Garl-X.

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