Developing Efficient Research Protocols to Meet Industry Needs

Efficient research strategies for natural products start, step by step, by building a foundation of knowledge. Commercial companies may find some difficulties in establishing meaningful working relationships with academic institutions, which often come down to issues with time and money. Most academic researchers have been trained in thinking along a well-defined track, with a long-term commitment. Most research projects in nutritional ingredients need rapid progression toward establishing a broader understanding of a product, at least initially.

Planning a research protocol on natural products in a segment where a good volume of research already exists requires careful evaluation using the published literature. The reported effects of product consumption should be evaluated, compared to published data and combined with the current needs of the client when building a research strategy.

In contrast, when someone walks out of the jungle with a new plant, having only local folk medicine or the words of a shaman to assist with the understanding of the plant’s potential, a different strategy is required. It is important to pay attention to claimed results, even if these are presented in unorthodox vocabulary or are in a context that may not make sense in Western medicine. A multi-pronged approach for a simple, but multi-faceted, pilot study is often needed to provide initial direction for how to foster understanding under the umbrella of scientific vocabulary. This often includes assessment of what cell types and cellular functions may be affected. Such a pilot study can often provide invaluable guidance for further planning and can save the inventor/client a great deal of money.

Research into finished dietary supplements or functional food/ beverage products is often charged with the goal of ultimately making health claims or structure/function claims in marketing. According to the newest FDA guidelines, health claims are for healthy people only, i.e. research data showing effects of a natural product on a healthy population. Structure claims involve proving a product contains a certain amount of a known compound. Function claims involve documenting that a product supports a certain biological function, either on isolated cells or on a whole person. Thus, for making structure claims, analytical chemistry is sufficient, whereas for function claims, other types of research are required in order to identify possible mechanisms of action.

Research directed at function claims ideally stays as close as possible to the whole human organism. However, the cost of conducting a full clinical trial before understanding mechanisms of action is prohibitive and unwise. Smaller pilot trials with a broad testing base can explore many possibilities of the action of a product; in addition, these should not be limited to the presumed mechanism of action. Also, it can be advisable at this stage to use parallel testing methods for approaching the same question.

Even before entering into such an exploratory pilot study using human subjects, it is often a good strategy to explore specific aspects of the action on live cells in laboratory tests (in vitro). For example, if a product is shown in vitro to inhibit the expression of inflammatory enzymes such as cyclooxygenase and lipoxygenase in cells, it provides a better rationale for entering into a clinical trial on relief from arthritic symptoms.

In addition, when developing research protocols, using a traditional pharmaceutical approach—one compound, one effect—is often not appropriate. The complexity of most natural products and extracts should be recognized as an advantage; however, this also means research needs to be approached in a different manner. Unfortunately, many natural products have painted themselves into a corner; their research and marketing claims evolve around knowledge of a single compound in the finished product.

It is admirable when an inventor/manufacturer stops and asks what are they missing? A seemingly dead-end product can be revived and brought to broader recognition by further research. Seeking a novel edge for a product involves risk and thinking out of the box. Staying open-minded regarding the effects that are experienced after consumption of a product and not assuming all the answers are known leads to the identification of new directions. Exploratory pilot studies can be undertaken to gain a broader understanding of the product. This exemplifies a situation where the inventor/manufacturer and the research laboratory must stay in close communication.

To truly evolve in the area of claims and product development, the natural products industry must get creative. For example, there is a need to move testing for antioxidant content and anti-inflammatory effects to a new level. The ORAC and TBARS tests will remain cornerstones for many aspects of natural products research and quality control. On the other end of the spectrum stands the clinical trial, where the end result of consumption of a natural product is examined. In the middle, we have a vast array of laboratory testing involving cells removed from the body. This type of testing is hugely important for making function claims. However, there is little agreement as to the types of cellular models that are ideal for answering specific questions. We need a proper debate and work toward agreements on standardization in this area.

The second area of major importance, one that may stand on the verge of a new breakthrough, is the effect of natural products on the biology of adult stem cells. This area may indeed be a cornerstone for explaining products that appear to have multiple effects not logically linked to specific diseases and not easily explained by other hypotheses.

The natural products industry is an exiting industry to be in, but in order to maintain and protect serious recognition, continued improvement of research strategies is necessary. 

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