Study Smart

The recent economic downturn has led manufacturers of all types of products to ask themselves: "How can we do more with less?" This holds true for nutraceutical manufacturers. Nutraceutical consumers, who are becoming more conscious of the potential connection between healthy products and a healthy life, want proof that nutraceutical products actually work before they make a purchase. Unfortunately for nutraceutical manufacturers, access to clinical studies is generally limited due to the cost and time constraints of conducting clinical trials.

Acute clinical studies provide a possible answer for companies struggling between the need for more efficacy research support and the significant financial and time investment required for clinical trial research. Acute clinical studies can also help companies identify effective ingredients early on in product development, saving potential costs down the road.

Acute clinical studies are designed to measure the effect of dietary supplements on a target's function in blood and/or blood cells over a short period of time. A target can be a gene product, such as an enzyme, or a process, such as oxidation in the blood. Published research has shown that certain targets can contribute to the development of chronic health conditions.

Some examples include:

• Nuclear Factor–kappa B (NF-κB): Too much of this protein complex plays a role in excessive inflammation.

• SIRT: Research has shown that this gene may control key processes involved in the development of metabolic conditions such as diabetes and obesity.

 Acute clinical studies that show how dietary supplements affect these targets can help product developers to identify what nutraceutical ingredients are best to include in blends designed to benefit specific health conditions. By conducting an acute clinical study first, prior to clinical trials, product developers can know functionality and bioavailability results quickly and at a significantly lower cost.

FutureCeuticals Inc. (Momence, IL) is an example of a company that uses target-specific acute clinical studies to create benefit-driven products. This type of testing is central to the company's TargeTest research program. The program focuses on number of blood targets, including CETP, PON1, SIRT, Elastase, and ACE, among others.

For example, TargeTest measures an ingredient's ability to help manage inflammation by analyzing activity of NF-?B in blood cells for two to three hours after ingestion of the ingredient. The results lead to two important conclusions. One is whether or not that ingredient is bioavailable, which is determined by measuring its effect in human blood. Second, the results can show whether or not the ingredient inhibits NF-?B. A positive result indicates that the tested ingredient could help regulate inflammation if used over a longer period of time.

Research has also identified dozens of other blood targets that play a crucial role in human health. In most circumstances, acute clinical studies can show how a food can affect targets in a dose- and time-dependent manner. Study results can also help determine the minimum effective dose of an ingredient, which is important information for final formulation of the product.

Acute clinical studies allow product developers to create new, differentiated, and benefit-driven products based on acute clinical testing in humans. This type of analysis, if performed on a significant number of human subjects, can be published as clinical discovery research.

Acute clinical studies can help companies scientifically support their products by determining minimum effective dose, showing acute functionality, and providing important information for the design of a successful clinical trial if further research is desired. These types of studies can also lead to future discoveries of new uses for traditional nutraceutical ingredients by using advanced target technologies such as genomics, proteomics, and metabolomics.

Zbigniew (ZB) J. Pietzkowski, PhD, is vice president of R&D at FutureCeuticals Inc. (Momence, IL). He specializes in clinical discovery research with a focus on molecular targets, biomarkers, genomics, and diagnostics as tools to identify and validate functionality of nutraceutical products.