Nutrition 21 is the company behind Chromax chromium picolinate and Diachrome, a patented combination of Chromax and biotin. According to the company, Diachrome has been shown to enhance insulin sensitivity and improve blood sugar metabolism - effects that could help diabetes sufferers manage their condition.
"One of the reasons we have been investing so heavily in science is that we think chromium will play a big role in diabetes care," company president and CEO Gail Montgomery told NutraIngredients-USA.com.
"People who are involved in government policy play a major role in bringing this about."
The results of the latest research funded by the company was announced just last week. In a randomized double-blind, placebo-controlled trial involving subjects with type 2 diabetes who were moderately obese and taking oral antidiabetic medications, the atherogenic index of plasma, a predictive marker for cardiovascular disease, was seen to be "significantly lower" in those taking Diachrome alongside daily treatment regimes, compared to those taking a placebo.
In particular, the company wants policy makers to be aware of early data coming out of its health outcomes initiative using Diachrome, on which it is currently working with XL Health.
This initiative, involving 453 patients across multiple centers, is investigating the effects of Diachrome on glycated hemoglobin, fasting plasma glucose, cholesterol and triglyceride profiles in patients with type 2 diabetes.
Earlier this month, the company announced the appointment of Debra Bass as government relations counsel to lead the awareness efforts at state and federal level.
Debra has already arranged a Diabetes Caucus meeting and will also be liaising with the NIH's National Center for Complementary (NCAM) and Alternative Medicine, National Institute of Diabetes and Digestive and Kidney Diseases and Office of Dietary Supplements. She will also work closely with the American Diabetes Association and the American Dietetic Association.
The company is also looking to communicate with payers, who reimburse patients of limited means for health care. Its aim is to demonstrate to them that Diachrome is effective, at a reasonable cost.
Since diabetes is a disease that tends to affect more people in lower socio-economic groups, co-pay for diabetes care can pose a problem for some sufferers.
A review of Diachrome outcomes is due to be published at the end of August, which will demonstrate its potential impact on the cost of care.
The labor/health subcommittee bill signed by President Bush in December 2004 contains report language encouraging NCCAM to expand its chromium research program by funding health outcomes initiatives.
"This has been important to elevate the importance of chromium in consumer and medical communities. It has also helped build collaborations for Native American studies," said Montgomery.
The suggestion has not yet resulted in a demonstration project, and such projects to date have been company funded. But Montgomery said that it has helped the company to continue its dialogue with NCAM and it is currently working on an appropriations request, which would actually see money put forward for this.
Montgomery said it is hard to say when this might occur, but that she "hopes to hear by the end of this calendar year" .
Another effort to raise awareness is the health claims petition associating chromium picolinate supplementation with reduced risk of insulin resistance, type 2 diabetes and related disease conditions, filed with the FDA in January 2004. A decision on this is still pending, having been subject to a number of delays.
"We have been told that the FDA will try to get it done within the 60 day extension, or within a subsequent 60 day extension," said Montgomery."It is a difficult agency to influence. Debra is working on the perimeter, talking to people who can guide on the process."