Nutrient biomarkers: NIH program aims to aid evidence-based policy

By Stephen Daniells

- Last updated on GMT

Related tags: Nutrition, Iom

The National Institutes of Health (NIH) has launched a new program to discover and develop valid biomarkers for all essential nutrients with the goal of generating evidence-based policy.

The Biomarkers of Nutrition for Development (BOND) Program will start by performing systematic reviews on six nutrients: Iodine, iron, zinc, vitamins A and B12, and folic acid (vitamin B9).

"The BOND program is committed to developing nutritional biomarkers that are accurate and can be used to assess nutrition across a variety of different settings,” ​explained Daniel Raiten, PhD, of the Endocrinology, Nutrition and Growth Branch at the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and project officer for the BOND program.

NIH defines biomarkers as: “Characteristics, which can be objectively measured and evaluated as indicators of normal biological processes, pathogenic processes, and pharmacologic responses.”

From six to 40

Speaking to NutraIngredients-USA, Dr Raiten explained that the BOND program​ had been inspired by his 35 years of work in this field and being faced with “data that aren’t comparable”​.

The project is initially focussing on the six nutrients because of their value to public health. “You have zinc, which has only one measure and that doesn’t tell you all you need to know,”​ said Dr Raiten, “and then you have iron with a myriad of measures.”

Writing in the American Journal of Clinical Nutrition​, Dr Raiten and his co-authors stated: “A process is needed to harmonize the global health community's decision making about what biomarkers are best suited for a given use under specific conditions and settings.”

The initial plan is to take on the six nutrients, and then expand to “all 40 essential nutrients”​.

Tracks and resources

BOND is divided into two main tracks: The first aims to provide advice on biomarkers, based on the results of the systematic reviews; the second aims to support researchers working to identify additional nutritional biomarkers and how best to use them.

The program is supported by the Bill and Melinda Gates Foundation, European Micronutrient Recommendations Aligned, the Micronutrient Genomics Project and PepsiCo. According to NIH, the program also involves collaborations with numerous US and global health agencies and private organizations.

IOM

Biomarkers are a topic of intense interest: The Institute of Medicine (IOM) released a report last year entitled Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease​.

Dr Raiten was quick to point out that disease biomarkers are not the same as the objectives of IOM report, noting that BOND focuses on biomarkers of nutrient status.

The IOM report’s authors recommended that FDA adopt a consistent scientific process and framework for biomarker evaluation across all regulated areas, including drugs, medical devices, biologics, foods, and dietary supplements. This harmonization, they argued, is crucial to “consistently and transparently judge the appropriateness and validity of the scientific benchmarks used in studies that companies provide to support health and safety claims for their products”​.

Comment

Commenting independently on the BOND program, Andrew Shao, PhD, vice president, global product science and safety for Herbalife Ltd. told NutraIngredients-USA that the "initiative represents a major step in the right direction"​ given that "accurate and reliable means to assess exposure, status, function and effect for many key nutrients are still lacking"​.

"The strengths as I see them include a global perspective and collaboration between government, academia and industry. ODS, ILSI, the Dairy Council and even a company (Pepsico). It is refreshing to see all the stakeholders come together to tackle such a huge endeavor. Both the scientific/research and policy aspects of biomarkers (i.e. how biomarkers are utilized to inform policy decisions) are global in nature, and purely from a scientific perspective the resources needed to identify and validate biomarkers are so enormous, collaboration amongst the major stakeholders is the only way to make progress. So these I see as positives,"​ said Dr Shao.

"Some limitations of the program include focus on only a handful of essential micronutrients (at least at this point), with no mention of bioactive food components or phytochemicals. Data validating the link between these food components and health are lacking, and the lack of validated biomarkers in the same four categories - exposure, status, function and effect - is the single greatest obstacle to fully realizing their benefit to health.

"There is also no mention of chronic disease and establishing biomarkers as surrogates; the program appears to be focused more on undernutrition. This is not a criticism, since global undernutrition is an important issue to address, but simply a limitation of the program as I see it. Finally, there is no mention of the IOM Biomarkers report from May 2010, which basically outlined the steps and necessary types of data needed to identify and validate biomarkers, which I find surprising,"​ added Dr Shao.

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