NEWtritious™ Functional Foods & Beverages and Medicus Research announced today that they have filed documents with the IRB (Internal Review Board) overseeing the study, officially beginning the clinical trial for the Kherb Appeal™ weight loss formulation. Utilizing a progressive new protocol for providing accuracy and authenticity in clinical study compliance, the parallel studies will test the NEWtritious™ Kherb Appeal™ weight loss product to demonstrate its efficacy on weight loss and satiety as a snack replacement for dieters, while improving metabolic functions regarding lipids and blood glucose levels. The goal is to establish Kherb Appeal™ as a functional food proving that this synergistic matrix of ingredients will be the new paradigm for healthy weight loss, and institute a much-needed accurate standard for clinical trials now and in the future.

NEWtritious™ formulated this nutritious instant pudding to suppress one’s appetite, maintain energy levels and sustain satiety (without harmful stimulants), and provide the necessary daily-recommended intake of vitamins, minerals and fiber. The Kherb Appeal™ product contains ingredients that provide the following mechanisms, which have been associated with weight loss:

•     Increasing satiety
•     Delayed gastric emptying
•     Balancing gut flora
•     Increasing insulin sensitivity
•     Inhibiting fatty acid production
•     Reduction of triglycerides
•     Reduction of lipids

Medicus Research designed the Systemedicus technologies to visibly prove accuracy and compliancy through a real-time recording on Apple® mobile devices including iPads and iPods. This technology helps to eliminate the potential for inaccuracies caused by human error and lack of off-site monitoring of participants. The patent pending SysteMedicus technologies include eConsent, eSource and eCompliance technologies which all ensure that the information is collected according to the FDA ALCOA standards (accurate, legible, contemporaneous, original, and attributable). This includes enhancing and documenting the informed consent process, and documenting accurate compliance of participation in the study by imaging, facial recognition with time/date stamps, and video interaction on mobile/hand held devices.

The Kherb Appeal™ randomized, double-blind, placebo-controlled, parallel-group, adaptive design study will evaluate the efficacy of the Kherb Appeal™ product compared to a placebo, to establish weight loss and satiety for an overweight and obese population as well as in a population with impaired glucose tolerance.* The 14-week study will include the following 160 participants with the following required demographics: Overweight and Obese Population

•     Evaluated to be in overall good health – between 30 and 65 years of age.
•     Body mass index (BMI) between 27 and 39.9 kg/m2.
•     Participants judged by the Investigator to be motivated to lose weight.

Impaired Glucose Tolerance Population

•     Evaluated to be in overall good health – between 30 and 65 years of age.
•     Body mass index (BMI) between 27 and 39.9 kg/m2.
•     Participants judged by the Investigator to be motivated to lose weight.
•     OGTT (75g glucola) peak value between ≥ 140mg/dl and ≤ 199mg/dl at screening visit.