Highly Bioavailable Formulation Efficiently Transfers Antioxidants
LONDON, UNITED KINGDOM, May 03, 2018 (GLOBE NEWSWIRE) -- Plandai Biotechnology Inc. (OTC Markets: PLPL) (the “Company” or “Plandai”), a producer of nutraceutical and highly phyto-available extracts, is pleased to provide an update to its Phytofare solution as a preventive mitigation against Type 2 diabetes.
In looking for a natural solution, epidemiological studies indicate that populations with a high intake of green tea catechins benefit in terms of reduced body weight, body fat, the balance of insulin and glucagon, maintaining blood glucose, and cardiovascular health. This is particularly true considering the strong research data from in vitro and animal studies where actions from green tea catechins have shown decreased carbohydrate absorption, decrease hepatic glucose production (the inability of insulin to suppress hepatic glucose production is a key defect found in Type 2 diabetes) and increased insulin sensitivity (the relationship between how much insulin needs to be produced in order to deposit a certain amount of glucose).
Due to the prominence of tea in the diet, the bioavailability of tea flavonoids has received attention in many human clinical studies. In green tea, 59% of catechins are EGCG, 19% EGC, 13.6% ECG and 6.4% EC. The bioavailability of EGCG and ECG are reported to be lower than EGC and EC. Another study also reported that after ingestion of green tea, EGCG, EGC, and EC concentration peak in plasma at 1 to 2 hours and gradually reduced to undetectable levels in 24 hours.
However, transferring the in vitro and animal study scientific findings to a delivery system that benefits humans has always been met with metabolic and degradation issues; as well as the low amount of catechins that are transferred to the blood plasma and the time they remain there. Furthermore, to partially achieve this success high dosage of catechins is required, inducing possible toxicity and side effects.
Phytofare® catechin complex is a highly bioavailable formulation of all eight catechins that have been clinically researched to efficiently transfer the antioxidants into the blood plasma, where they remain for more than 24 hours. Furthermore, the daily dosage has been established at more than twelve times less than generic green tea, thereby delivering a potential active antibiotic with low dosage and without toxicity or side effect issues.
Plandai’s proprietary and patented processing and extraction technologies, release from live plant material antioxidant and phytonutrient molecules with high bioavailability through improved isomeric identity and compatibility in humans and animals. (Validated by USDA, published in Food Chemistry 2012 and NW University Drug Development platform 2015).
Plandai has established a platform to undertake clinical investigations to scientifically validate Phytofare catechin complex as a natural solution in the prevention and containment of Type 2 diabetes; and where the company has previously conducted two bioavailability studies involving Phytofare®. The first study, completed in April 2014, was a human clinical trial involving Phytofare® and demonstrated that Phytofare® was able to deliver all eight primary catechins to the blood stream compared to just 3 catechins from a generic green tea extract. Further, this clinical study showed that the concentrations on catechins in the blood stream were greater than 12 times that of the generic and that Phytofare® catechins remained in the blood stream for over 24 hours, whereas the generic catechins were absent after six hours.
The second study was specifically designed to validate the improved bioavailability with entrapment of Phytofare in a liposome delivery system. This study involving eighteen primates who were administered a single Phytofare dose with various blood draws performed over a 48-hour period. The outcome of the study is to establish a high level of bioavailability in order to formulate a correct dosage for the Type 2 diabetes clinical study including the “wash out period”. The study has been completed and the analytical results are pending.
The company has finalized the protocols for a human clinical study titled: Clinical Trial to determine in humans the efficacy of Phytofare® in lowering HbA1C levels in Type 2 Diabetic patients. A three-arm, phase 2 double-blind randomized controlled clinical trial on the safety and efficacy of Phytofare® Catechin Complex and Phytofare® combined with Vitamin D and Omega 3 fatty acids, formulated in liposome iotas, in patients with Type 2 Diabetes Mellitus.
The clinical trial will be a double-blind study involving 144 patients. The aim of the study is to determine the effectiveness of Phytofare® catechins, in the regulation of pancreatic beta cells together with the impact on blood glucose levels over an extended period to demonstrate both the cause (pancreatic fat and vitamin D deficiency) and effect (improvement in glucose regulation) with glycemic control using hemoglobin A1C levels as a target.
With positive findings, the commercial objective is produce a formulated oral capsule supported by a nutraceutical structure-function claim.
About Plandai Biotechnology, Inc.
Plandai Biotechnology, Inc. (OTC Markets: PLPL) develops highly bioavailable, phytonutrient rich extracts which are being utilized to deliver a new family of nutraceutical supplements. Plandai Biotechnology, through its South African subsidiaries, controls every aspect of production, from growing specific raw materials such as green tea on its farms to producing its proprietary Phytofare extract, allowing the Company to guarantee the continuity of supply as well as quality control throughout the entire process. The manufacturing facility has also been engineered for citrus fruits and the recovery of limonoids. Targeted industries for the Company's products include animal husbandry, dietary supplements and diabetes. Plandai Biotechnology is headquartered in London, United Kingdom. For more information, please visit: http://www.plandaibiotech.com
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