ABSTRACT
Introduction ............................................................................................................ 270 Methods .................................................................................................................. 271
Selection of Subjects ......................................................................................... 271 Dietary Intervention Study ................................................................................ 271 Sampling Procedure .......................................................................................... 273 C-Reactive Protein Measurement ...................................................................... 273 Cytokinesis-Blocked Micronucleus Assay ........................................................ 273 RNA Isolation and Storage ............................................................................... 274 Gene Expression Arrays .................................................................................... 274 Gene Expression Data Analysis ........................................................................ 274
Results .................................................................................................................... 274 Adherence to the Diet........................................................................................ 274 C-Reactive Protein Levels ................................................................................. 275 Cytokinesis-Blocked Micronucleus Assays ...................................................... 275 Gene Expression Arrays .................................................................................... 275
Discussion .............................................................................................................. 277 Conclusions ............................................................................................................ 278 Acknowledgments .................................................................................................. 279 References .............................................................................................................. 279
One of the limitations for small-to medium-sized food companies to prove efcacy of functional foods, or novel diets, is the cost of human clinical trials. Most new functional foods are developed based on a prior hypothesis. However, the food or dietary context may negate such hypotheses being correct. Thus, a costly human trial, of the standard necessary for a health claim, may fail to prove the desired effect of the new food. A variant of nutrigenomics, which is food or diet-focused, is sometimes being described as foodomics [1]. It enables non-hypothesis-based establishment of appropriate biomarkers to help reduce the test time and increase the efcacy of establishing the quickest and most effective test methods to move directly to a health claim. We have tested the ability of this approach to prove the human efcacy and to derive insights into the mechanism of action of a modied diet, in a proof of principle study in Auckland, New Zealand.
