Biomarkers in Nutrition: New Frontiers in Research and Application

Agenda

* Presentation times are subject to change.

Abstracts

Biomarkers of Nutrition for Development (BOND) Program
Daniel J. Raiten, PhD, National Institute of Child Health and Human Development, NIH

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH)/U.S. Department of Health and Human Services, with support from the Bill and Melinda Gates Foundation, PepsiCo, and other NIH institutes and centers,and in partnership with a consortium of public (e.g., NIH, CDC, USDA, USAID, WHO, UNICEF, WFP) and private (e.g., ILSI, GAIN, MI) agencies and organizationsrepresenting the global food and nutrition enterprise, has created the Biomarkers of Nutrition for Development (BOND) Program (http://www.nichd.nih.gov/global_nutrition/programs/bond/). The BOND is intended to achieve three primary goals: 1) to address the need for discovery, development, and implementation of reliable and valid biomarkers to assess nutrient exposure, status, function, and effect, 2) develop a process to harmonize the decision making process about what biomarkers are best for use in the full range of activities represented by the global food and nutrition enterprise, and 3) use information developed through 1 and 2 to provide evidence based advice to those involved in food and nutrition related activities. The scope of that advice would include those involved in basic/clinical research, clinical care, program/product development/monitoring/evaluation, and generation of evidence-based policy. To achieve these goals and establish a proof of concept for the BOND approach, the initial efforts of the BOND program arefocused on six“case study” nutrients: Iodine, Vitamin A, Iron, Folate, Vitamin B12 and Zinc, chosen by the BOND steering committee for their public health importance and because they represent the range of challenges confronting the user communities.

The Use of Biomarkers to Substantiate Health Claims
Paula R. Trumbo, PhD, US Food and Drug Administration

FDA conducts premarket reviews of health claims for the labeling of conventional foods and dietary supplements. Health claims describe the relationship between a substance (food or food component) and risk of a disease or a health-related condition. A health-related condition can be a qualified biomarker for disease risk (i.e., surrogate endpoint). Surrogate endpoints are an important part of FDA’s scientific review of health claims. Therefore, there is continued interest in the state of the scientific evidence for the qualification of potential surrogate endpoints.

Biomarkers of Selenium Status
Gerald Combs, Jr., PhD, Grand Forks Human Nutrition Research Center, USDA-ARS

Status with respect to the essential element selenium (Se) is considered for four purposes relevant to human nutrition and health: assessment of Se intake/exposure; assessment of risk of nutritional Se deficiency; assessment of Se adequacy for cancer risk reduction; assessment of risk of Se toxicity. Each purpose relies on a different set of endpoints with different evidence bases. Selenium intake/exposure is generally assessed on the basis of the Se contents of accessible specimens, e.g., plasma/serum, urine, hair/nails, buccal cells. Nutritional Se status is assessed on the basis of biomarkers related to the metabolic function of the element, i.e., specific selenoproteins the optimal expression of which defines nutritional Se adequacy. The potential for Se to affect cancer risk is a question being actively researched. Current evidence suggests that risk reduction occurs among those with nutritionally adequate, but not high, Se status. Accordingly, it appears that candidates for Se-protection against cancer can be identified using Se-biomarkers similar to those used to assess Se exposure, but with the application of a target range. The potential for very high Se status to produce adverse physiological effects has been established from animal studies and accidental exposures of humans, which have produced an array of clinical indicators but few biomarkers with predictive potential. For this reason, the default choice has been to use as risk indicators the highest Se tissue levels observed with no adverse effects. The dose-response relationships of these various Se biomarkers depend on the chemical form of Se consumed, with sources of selenomethionine (e.g., plant foods) supporting higher tissue levels than sources of inorganic Se (selenite, selenate) or selenocysteine (e.g., animal products). The use and interpretation of Se-biomarkers for the above purpose will be discussed in light of current understanding of Se metabolism.

Rationale and Process for Developing Biomarkers for Sarcopenia
Stephanie Studenski, MD, University of Pittsburgh

Sarcopenia, defined here as reduced muscle mass, is common among older adults. It is a potentially modifiable contributor to dynapenia, or muscle weakness, which is strongly related to serious consequences such as reduced physical performance, disability and increased mortality. Preliminary criteria have been proposed, but have not been compared across data sets or formally evaluated for diagnostic test characteristics. Potential interventions on sarcopenia are emerging rapidly, but trials cannot be implemented until eligibility can be clearly defined. In order to address the need for further evidence about muscle mass, strength and aging, an initiative was developed in 2008 under the aegis of the Foundation of the NIH (FNIH). Investigators representing nine studies and over 23,000 diverse older adults were selected to join the Sarcopenia Project Team, which has performed pooled analyses in support of criteria for clinically important weakness and low muscle mass.

Markers of Dietary Intake and Risk of Cancer
John Milner, PhD, National Cancer Institute, NIH

The world is changing as evident by an alarming increase in projected increase in non-communicable diseases including cancer incidence. Premature loss of life and cost of medical treatments necessitate that strategies for effective prevention be implemented. Undeniably mounting evidence continues to point to the need to alter dietary habits as an effective and cost-efficient approach for reducing cancer risk and for modifying the biological behavior of tumors. However, it is clear that not all individuals benefit equally from dietary change. Thus, there is a crying need for the identification of predictive, validated and sensitive biomarkers, including those that assess: (1) “intake” or exposure” to a specific food or bioactive component, (2) specific biological “effect(s)” that are linked to cancer, and (3) individual “susceptibility” as a function of nutrient–nutrient interactions and genetics. These biomarkers must be readily accessible, easily and reliably assayed, and predictive of one or more key processes involved in cancer. The response to a food is determined not only by the timing and effective concentration of the bioactive food component(s) reaching the target tissue, but also by the amount of the target requiring modification. These biomarkers can also be influenced by insults to the body including excess calories, microbial contaminations, viral infections and environmental exposures. Thus, the response to foods and their bioactive components will vary from individual to individual. Relevant examples about the role of “omics” as modifiers of the response to specific food components will be provided. Overall, the key to a personalized response to diet is a better understanding about how nutrigenomics can be used to predict proteomic and metabolomic changes in normal versus cancer cells and how these can be developed into sensitive and reliable biomarkers.

Blood-Based Markers of Nutrient Status and their Association with Metabolic Risk
Steven M. Watkins, PhD, Tethys Bioscience

Nutrition has a profound impact on the progression of metabolic disorders including diabetes, obesity and cardiovascular disease. Our knowledge of the relationship between nutrients and metabolic risk comes largely from dietary record data in large outcome trials or from smaller intervention studies where surrogate markers of outcome were measured. We have developed assays to quantify the blood levels of many important dietary nutrients including fatty acids, sterols, amino acids, and other markers of nutrient status including acylcarnitines and bile acids. We have used these assays to identify the relationship of blood measures of nutrients with metabolic outcomes including conversion to diabetes. Here we present the results of these studies and identify blood-based nutrients that are particularly strong predictors of metabolic risk. Using a measurement strategy as opposed to diet recall could enable a personalized approach to nutrition where individual needs can be measured, and nutrient advice can be dispensed in a treat-to-target paradigm instead of as global recommendations.

Amino Acid Based Biomarkers for Indicating Nutritional and Disease States
Takeshi Kimura, PhD, Ajinomoto, Co., Inc.

Information on physiological and nutritional states can be obtained by analyzing the interrelationships between metabolites such as amino acids. We have developed a way to generate markers comprised of plasma amino acid concentrations (AminoIndexTM) that can separate various physiological states. The AminoIndexTM is currently in use in a number of hospitals in Japan to detect the risk for 5 cancers. As this technology allows the generation of markers to any physiological state for which plasma amino acid data is available its application in nutrition is highly feasible.

Biomarkers of Fruit and Vegetable Intake
Michelle McKinley, PhD, Queen's University of Belfast

Observational evidence consistently shows that consumption of a diet rich in fruit and vegetables may offer protection against diseases such as cardiovascular disease and cancer. Assessment of dietary intake is complex and prone to many sources of error which may impede progress in research on the dietary determinants of disease risk. More objective biomarkers of fruit and vegetable intake, such as blood biomarkers, may offer a more quantitatively objective method of measuring fruit and vegetable intake in both observational and interventional research. Several substances found in fruit and vegetables have been proposed to be potential biomarkers, and these include vitamin C and the carotenoids (particularly lutein, β-cryptoxanthin and β-carotene). Fruits and vegetables also contain a wide variety of flavonoids and other polyphenolic compounds, and several of these have been examined individually as potential biomarkers. The evidence regarding the usefulness of the main biomarkers of fruit and vegetable intake to act as objective indicators of compliance in dietary intervention studies will be reviewed and on-going work at Queen’s University Belfast, which is continuing to examine the potential of blood biomarkers to act as predictors of fruit and vegetable consumption, will be discussed.

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