Newtritious™ Functional Foods & Beverages and Medicus Research Set a New Precedent in Clinical Studies Protocol

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Utilizing NEWtritious™ Kherb Appeal™ Weight Loss Product, the Medicus Research SysteMedicus cutting-edge technology will ensure accuracy in participant consent, compliance and documentation. The result will establish a new gold standard for clinical trials.

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.

*As most people are unaware of possible elevated blood sugar and lipids levels, this study can be utilized as an educational and screening venue to determine whether they may be at risk for diabetes. Any subject found to have active diabetes during the screening process will be referred back to their physician for necessary treatment.

About NEWtritious™ Functional Foods & Beverages
NEWtritious™, a forward-thinking designer/manufacturer/marketer of highly fortified, nutrient-dense foods that are “Better Tasting & Better For You”™ is dedicated to creating value-added products that will make a difference in improving and maintaining one’s health by delivering sufficient quantities of bio-available ingredients. The company’s Kherb Appeal™ weight loss formulation is presently in two, double blind, placebo-controlled clinical trials to substantiate potential claims that it might lower lipids and blood sugar levels. All products are designed to comply with food and supplement regulations created by the United States of America, Canada, Japan and the European Union. For more information, please visit http://www.NEWtritious.com and http://www.kherbappeal.com.

About Medicus Research
Medicus Research LLC is the premier Contract Research Organization for the Natural Health Products industries including Dietary Supplements, Functional Foods, and Botanical Drugs. Medicus Research has designed and completed over 100 clinical trials. As a full-service CRO, Medicus Research provides comprehensive research services from protocol design through the final report, and has established GCP and FDA compliant SOPs, internal QA processes, and proprietary management technology systems, which ensure the highest quality for all aspects of the study process. Medicus Research has wholly owned GCP compliant research centers in the US and in the Philippines for running any size study. All study procedures are managed and monitored through the patent pending SysteMedicus monitoring system to ensure progress, compliance and quality. For more information, please visit http://www.medicusresearch.com and http://www.Systemedicus.com.

Media Contact:
Janet Margolis
310-745-8282; janet(at)janetmargolis(dot)com
http://www.kherbappeal.com

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Janet Margolis

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