Nutrition 21 begins Diachrome trial amongst Native Americans

Related tags Obesity Diabetes

Nutrition 21 is collaborating with the Native American Mandan,
Hidatsa and Arikara (MHA) Nation on a trial to assess the health
benefits and savings afforded by using its Diachrome chromium
picolinate and biotin formulation for type-2 diabetes sufferers in
clinical practice.

Six hundred MHA tribal members diagnosed with type 2-diabetes will take part in the four-month physician-supervised health outcomes initiative.

Statistics show that Native Americans are 420 percent more likely to die from diabetes than the rest of the United States population. According to a report by the NIH in 2002, around 15 percent of American Indians and Alaska Natives receiving care from the Indian Health Service have been diagnosed with diabetes - that is, 105,000 individuals.

Due to forced relocation from river bottomlands to prairie uplands in the 1940s and 50s, a large number of MHA tribal members who had previously grown their own livestock and food crops had to change their diets. A reliance on processed and sugar-rich foods has led to increased incidence of obesity and its associated health conditions, including diabetes and cardiovascular disease.

"Diachrome supplementation will be added to our existing diabetes treatment program, which includes health education, diet, exercise and anti-diabetic medication,"​ said Dr Corey Arcelay, a physician for the MHA Nation who will supervise the program.

He added that Diachrome will be included in the Indian Health Services formulary stock if initial clinical results are confirmed by the study over the next four months.

Likewise, Nutrition 21's plans do not stop at the MHA Nation. It plans to expand its Diachrome Physician Supervised Health Outcomes Initiative later this year to tribal healthcare leaders serving an estimated 38,000 Native Americans on four Indian Reservations in North and South Dakota.

"Our ultimate business objective is to secure wide scale adoption of Diachrome as a treatment protocol in the management of type 2 diabetes, not just in minority populations in the US, but in affected populations across the globe,"​ said Gail Montgomery, president and CEO of Nutrition 21​.

At the end of last year Nutrition 21 completed a randomized, double-blinded, placebo-controlled clinical trial, carried out in partnership with XL Health, into the effects of Diachrome people suffering from type 2-diabetes.

The results were said to be "positive"​ and the company is sharing the data with business partners and medical experts with a view to the nutritional therapy being used in clinical practice for diabetics at risk from heart disease.

An economic analysis was also undertaken last year, based on the interim results of two trials which suggested that taking daily Diachrome supplements lowered a marker of long-term blood sugar control in 87 per cent of patients.

If the results of future studies concur, analysts suggest that diabetes patients using Diachrome could save between $405 and $729 in treatment costs each year. Those savings would double for patients with diabetes and heart disease, and triple for patients with diabetes, heart disease and hypertension.

For the quarter ended 31 December 2004, the company reported a 12.6 percent increase in sales - reaching $2.6 million compared with $2.3 million for the same period of 2003. Net loss was reduced from $1.2 to $0.29 million, or -$0.03 to -$0.01 per diluted share.

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