LONDON, UNITED KINGDOM--(Marketwired - Aug 25, 2016) - Plandaí Biotechnology, Inc. (OTCQB: PLPL) ("Plandaí" or "the Company"), producer of the highly bioavailable Phytofare® catechin complex, today announced that it has reached an agreement in principal with North West University in South Africa, to begin human clinical trials on the island of Mauritius, a member of the SADC group of African countries, to determine the effectiveness of using Phytofare® catechin complex in regulating insulin levels in Type II Diabetes patients. North West University and the Company are finalizing the trial protocols which has a provisional start date of November 2016. Mauritius was selected as the trial site because, according to the World Health Organization and the International Diabetes Federation (IDF), the prevalence of Type II Diabetes in Mauritius in 2015 was a world-leading 16.28%. Worldwide as of 2013, 382 million people, or 8.3% of the adult population have diabetes, with Type II Diabetes making up about 90% of the cases. In 2014, the IDF estimated that diabetes resulted in 4.9 million annual deaths.
The proposed double-blind study will encompass 100 patients over 3 months, with a cross-over to the alternative treatment after 3 months, resulting in a total trial duration of 6 months. Compared to generic green tea extracts, Plandaí's Phytofare® Catechin Complex has been clinically shown to deliver ten times greater levels of catechins to the blood plasma where they remain at therapeutic levels for over 24 hours.
Data from in vitro and in vivo studies suggest that green tea catechins, in particularly EGCG, exert anti-obesity effects via several mechanisms including inhibition of adipocyte differentiation and proliferation, reduction of fat absorption, and the reduction in fat mass, tricylglycerides, free fatty acids and total cholesterol. The majority of human intervention studies investigating glucose homeostasis further demonstrate improved glucose levels in response to green tea catechins. Human studies have shown anti-obesity, anti-diabetic and cardio-protective effects of green tea catechins (1).
Roger Baylis-Duffield, Chief Executive Officer of Plandaí, commented, "Diabetes is now the leading cause of death in South Africa and the rates are only climbing through much of sub-Sahara Africa and the developing world where fat-rich foods have supplanted traditional diets. There is a strong body of scientific research that points to the effectiveness of green tea catechins in managing obesity, high blood pressure, diabetes and other diet-related diseases. However, as we all know, like many botanical ingredients green tea is poorly absorbed into the blood stream, rendering it an ineffective primary control therapy. Phytofare®, on the other hand, which has ten-times greater absorption, may very well provide an inexpensive, all-natural solution to these diseases. Our clinical trial is designed to build on this prior research and show the benefits of Phytofare® in managing glucose levels, with a short-term goal of having a consumer-ready capsule product by September, 2017."
(1) F. Thielecke, M. Boschmann / Phytochemistry (2009) "The potential role of green tea catechins in the prevention of the metabolic syndrome"
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About Plandaí Biotechnology, Inc.
Plandaí Biotechnology, Inc. and its subsidiaries develop highly phyto-available™ extracts. Plandaí Biotechnology controls every aspect of the process, from growing the raw materials on its farms in South Africa, to producing its proprietary Phytofare® extracts in-house, allowing the Company to guarantee the continuity of supply as well as quality control throughout the entire process. Targeted industries for the Company's products include beverage, cosmeceutical, wellness, nutriceutical, anti-aging, and pharmaceutical. For more information, please visit http://www.plandaibiotech.com.
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