New Clinical Trial Uses fMRI to Demonstrate Stress Reduction after Acute Administration of Sceletium
Study is the First to Test the Activity of Sceletium tortuosum on Brain Activity and the First to Study the Effects of a Dual PDE4 and 5-HT Reuptake Inhibitor in Humans
PLT Health Solutions, Inc. and HG&H Pharmaceuticals Pty. Ltd. announced the publication of a clinical trial that used functional Magnetic Resonance Imaging (fMRI) technology to study the effects of acute (short term) supplementation with Sceletium Tortuosum on the “threat circuitry” of the human brain. The double-blind placebo-controlled crossover trial conducted with 16 healthy university students showed that 25 mg of Sceletium reduced anxiety-related activity of the amygdala and its associated anxiety circuitry within 2 hours of administration. These results provide the first evidence for the areas of brain where Sceletium’s anti-anxiety activity acts, and confirmation of the potential to help in the management of stress.
This is the first patented, standardized and clinically studied extract of a unique selection of the South African plant Sceletium tortuosum. It is marketed to nutraceutical and functional food and beverage producers who are interested in incorporating this innovative, evidence-based ingredient in products that experientially support reduced anxiety, enhanced mood, and improved cognitive function. In a related development, PLT Health Solutions announced that HG&H Pharmaceuticals has been awarded U.S. Patent #8,552,051 covering the use of one of the key alkaloids – mesembrenone – for its PDE4 and serotonin-reuptake inhibition properties.
According to Barbara Davis, Director, Medical & Scientific Affairs at PLT Health Solutions, the new study gives further depth to the understanding of Sceletium as a dual 5-HT reuptake and PDE4 inhibitor in helping to manage stress. “Anxiety is characterized by hyper-responsivity to mild threats and the amygdala is the part of the brain that manages threat activity. This study is the first of its kind to directly examine the effects of these types of compounds on brain activity. It further supports the science on the mechanisms of action, and has pioneered the use of brain-imaging technology to evaluate and validate the activity of a plant used for centuries by the San people of southern Africa,” she said. “We’re pleased to be able to offer this type of leading edge science to our customers as they look to create innovative consumer products,” she added. The study, entitled Acute effects of Sceletium tortuosum, a dual 5-HT reuptake and PDE4 inhibitor, in the human amygdala and its connection to the hypothalamus (Terberg, et. al. 2013) was conducted at the Department of Psychology at Utrecht University in the Netherlands and the Department of Psychiatry & Mental Health at the University of Cape Town in South Africa.
HG&H Receives Patent on Use of Sceletium and Components for PDE4 Inhibition
Sceletium Tortuosum is a patented, proprietary extract of the South African traditional medicinal plant Sceletium tortuosum. It is standardized to total alkaloid content and conforms to a defined alkaloid profile for four main actives: mesembrenone, mesembrenol, mesembranone and mesembrine. According to Seth Flowerman, Director of Business Development, it is the unique ‘fingerprint’ that is the subject of clinical trials, an extensive safety portfolio and the current patent portfolio. Distinguished by its relatively low level of mesembrine and relatively high level of mesembrenone. The U.S. patent recently awarded to HG&H Pharmaceuticals protects the modulation of 5-HT and PDE4 and the application of mesembrenone as a PDE4 inhibitor,” he said. “The issuance of this patent underscores the unique composition and functionality of Sceletium as an ingredient. Combined with the continuing program of scientific support, it helps companies who incorporate it into their finished products differentiate themselves and build trust with consumers,” he added.