During the last 10 years or so, the decision whether to opt for a clinical trial in order to substantiate claimed health effects for a food or food supplement product has gained strategic importance in Europe. Where formerly such trials were considered luxuries left to big companies, changing regulations are currently forcing all manufacturers in the EU to at least consider this route.

While the generic 13.1 health claims give marketers the opportunity to make certain claims based on vitamins and minerals (provided the respective conditions of use are met), this does not exactly lead to standout products or convincing USPs (unique selling propositions).

Thus, the biggest driver currently compelling companies to conduct research on their products is the fact that changing regulations, particularly the relatively recent Health Claims Regulation, require manufacturers to invest in clinical trials for health claim applications if they wish to use a proprietary health claim.

Regulations Raise the Bar
However, the kinds of clinical trials that are conducted on food products are different today than 10 or 15 years ago, when marketing studies were generally all that was required to generate USPs.

Scientific standards have completely changed for foods and, incidentally, for traditional herbal drugs, due to regulatory changes. Traditional herbal drugs now have to be produced according to Good Manufacturing Practice (GMP) standards, which involve strict requirements for the characterization, standardization and stability of products.

On the other hand, claims on foods need to be approved by the EU commission according to the Nutrition and Health Claims Regulation (NHCR). This approval involves what amounts to drug trial standards for nutrition trials looking to demonstrate health effects. The medical food legislation is being revised and currently represents a black box as to what kind of medical food products will be able to survive in this category. Overall, it is safe to say that nutrition science is being pushed to an increasingly higher level by continuing regulatory changes.

Points to Consider
Once a manufacturer has decided to pursue a proprietary health claim, there are some points that should enter into the considerations.

The challenges faced by researchers when designing and conducting clinical trials on nutraceuticals are manifold. Nutraceutical testing is practically a science in itself, and though the quality standards are similar, it is in many cases quite dissimilar to drug testing.

Let’s start with the practicalities of the trial itself. Nutraceuticals as ingredients of conventional or functional foods are provided in a delivery form very different from drugs. They may require sophisticated logistics, like adequate cooling chains, large storage space, or complicated timing aspects due to short shelf lives.

Another aspect specific to nutritional trials is the choice of the study population. The selection of inclusion and exclusion criteria is of utmost importance, as the condition tested may not be a disease. However, an improvement of the respective ailment in the selected subjects needs to be achievable in the trial.

Probably the most important difference to drug trials relates to the nature of nutraceuticals themselves. Health effects of nutraceuticals are often rather small and can easily be affected by heterogeneity of subjects and environmental factors. Effects may be jeopardized by confounding factors such as eating, smoking, exercise habits, etc., and they need to be reported by trial participants in diaries that should be implemented in the study setup.

The CRO Advantage
Therefore, in order to duly provide for different challenges related to conducting successful studies, working with a contract research organization (CRO), such as analyze & realize, with specific experience in studies with natural products is a clear advantage. Appropriate recruitment, quality in logistic procedures, sample and data handling, as well as statistical knowhow are essential for a successful trial. Regulatory expertise is absolutely necessary. Therefore, in particular for companies with limited regulatory resources, combined service providers that have in-house knowledge of clinical and regulatory aspects and who work in teams to elaborate optimal trial designs are strongly recommended.

A clear advantage of working with a CRO like ours is the “one stop shop” service. These organizations are able to provide the entire panel of relevant activities, ranging from product concept development, clinical trial planning and professional conduct, up to result generation and subsequent regulatory submission. Another important aspect of this service is the guaranteed fulfillment of high quality assurance standards, including Good Clinical Practices (GCP) and other specific regulatory requirements.

The implementation of a quality management system based on standard operating procedures is important for meeting authority standards, be it those of drug or of food regulatory bodies. Furthermore, CROs have qualified procedures in place for sample and data handling; they use qualified statisticians for protocol planning and data analysis. Our prime concern is meeting sponsor budgets and timelines. Therefore, CROs have adequate recruitment and operational methods in place that allow for efficient inclusion of subjects into the clinical trial and conductance of the trial according to plan.

All this makes a CRO such as ours the most suitable partner for manufacturers wishing to make the most of their products’ potential.

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Joerg Gruenwald
analyze & realize ag

Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; E-mail: [email protected]; Website: www.analyze-realize.com.