Divinia Water Secures IRB Approval for First-of-its-Kind Clinical Trial
Idaho Falls, IDAHO (November 28, 2018) -- DIVINIA Water, Inc. and the National University of Natural Medicine (NUNM) announce a revolutionary study on DIVINIA Water's effect on particular human health problems, approved by NUNM's Institutional Review Board.
The clinical trial will test the effects of DIVINIA Water on chronic kidney disease (CKD) and several forms of hepatitis. The study was formally approved to enter the clinical trial testing, which should begin in early 2019 with trials conducted by the Helfgott Research Institute at NUNM in Portland, Oregon.
"To get a fully accredited university on board for this study is extraordinary," said Steven Sedlmayr, CEO of Divinia Water. "We can do a medically approved clinical test on DIVINIA Water's potential benefits for specific patients. This is the first of its kind. To my knowledge, it's never been done before."
The protocol for the study, developed by NUNM and approved by the IRB, tests DIVINIA Water's effects compared to the effects of drinking commercially available bottled water.
DIVINIA's expectancy is that the trial's results will show that their water contributes to a more natural and holistic approach to care for CKD and hepatitis with benefits that surpass the current standard of care.
The Center for Disease Control estimates over 30 million American adults have CKD. The kidneys balance electrolytes in the human body, maintaining the proper levels of salts. The liver and the kidneys are major organs, and provide for the body’s filtration system, along with other critical functions.
According to the CDC, death rates from chronic liver disease increased 31 percent from 2000 to 2015. That's an increase of 20.1 per 100,000 to 26.4 among people aged 45-64.
The liver is the largest of the glandular organs. It features over 200 functions in the human body. To keep it healthy, or return it to a healthy state, is critical for patients to maintain health.
"Water is the battery of life," said Sedlmayr. "But, too much of our water supply is contaminated. We believe this formal clinical study will show DIVINIA Water helps maintain kidney and liver health- a first for any water on Earth!"
"This is not an evolutionary step, but rather, a revolutionary step," Sedlmayr said. "This trial could position DIVINIA Water as the leader in functional water for health reasons, as we will be the only company to ever perform a clinical trial on the effects of drinking a particular water and to measure the effects upon particular organs and diseases."
Since DIVINIA Water is a unique, ultra-purified water with distinct alterations to its electromagnetic particle properties, along with the depletion of heavy water particles (or Deuterium Depleted), this trial will only apply to DIVINIA Water and no other waters.
"An IRB approval is a crucial step in the process of a clinical trial, and might be the largest barrier to overcome," Sedlmayr said. "Their approval allows us to use one of the most powerful tools in clinical research, the randomized controlled trial (RCT)."
An RCT allocates patients by random to receive one of multiple clinical interventions. One intervention is the standard of comparison, or control. Investigators study two or more interventions in a series of individuals who receive them in random order.
"With the challenge of the IRB behind us, and the clinical study in front of us, we've positioned DIVINIA to pull away from the pack and be the front-runner in the functional, wellness water category," Sedlmayr said. "Over the years, our customers have provided numerous amounts of narratives and anecdotal testimony to their bodies' responses to DIVINIA Water. We expect that to be highlighted in the clinical study, clarifying our position in the marketplace. We have already sent several cases of health responses to NUNM for its review, and that was a factor in the decision to move ahead with the clinical study and pass the IRB review. We are working with NUNM to possibly publish several of these cases at some time."
"We're in an expansion phase to gear up for the considerable response we expect from this course of action," added Crosby Sedlmayr, Vice President of Operations for DIVINIA.
Preliminary results are expected in 2019.
About DIVINIA Water:
DIVINIA Water is a bottled water brand focused on offering uniquely pure, clean, functional, eco-friendly and hydrating water. Purified through our proprietary purifiers. There are no other substances added to DIVINIA water, with all solids removed; DIVINIA's extraordinary functionality comes from its exclusive process. Bottled in glass bottles for easy recycling, DIVINIA is headquartered in Idaho Falls, Idaho, and is currently offered in seven retail locations in conjunction with our online store. Recently, DIVINIA began exclusive distribution to Hawaii with plans for aggressive expansion his year. www.diviniawater.com.
Established in 1956, National University of Natural Medicine is the oldest accredited naturopathic medical university in North America and a leader in natural medicine education and evidence-based research. NUNM had its beginnings in the early 1950s, in response to the termination of the naturopathic program at Western States Chiropractic College. Members of the profession from Oregon, Washington, and British Columbia planned the founding of the University and in May 1956, in Portland, Oregon, Drs. Charles Stone, W. Martin Bleything, and Frank Spaulding executed the Articles of Incorporation of the National College of Naturopathic Medicine. After 50 years, in July 2006, NUNM changed its name to National College of Natural Medicine to be reflective of its two core programs and inclusive of any future offerings. In June 2016, changed its status and name to National University of Natural Medicine. www.nunm.edu
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