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Clinical Research: A Tool to Support Nutraceutical Product Claim

03 Jun 2019

Nutraceuticals are the products that have both nutritional and pharmaceutical characters. Therefore they are used as a dietary supplement to modulate the symptoms of various diseases and conditions by providing physiological benefits against chronic diseases.

Due to higher consumer acceptability in the US and Japan, these countries have the most potential markets worldwide.

As the nutraceutical industry is growing, likewise various commissions and regulations are also under enforcement to control and to approve such health products and their health claims.

In the last decade, nutraceuticals have emerged as a booming market in India. Food Safety and Standards Authority of India (FSSA) is responsible for the regulation and approval of nutraceuticals in India. This authority was established by the enforcement of the Food Safety and Standard Act, 2006.

As per the regulatory requirement, the nutraceutical benefits must be justified through scientific as well as clinical evidence regarding their therapeutic claim for market approval. The claim can be substantiated either by selecting ‘generic claim’ authorized for vitamin/multivitamin and minerals (Limited number of substances) or by opting for a clinical trial/clinical research.

Types of health claims usually are:

  • General level health claim:which refers to a nutrient of a substance/product
  • High level health claim:which refers to a nutrient which relates to a biomarker towards the therapeutic claim


Once a manufacturer ensures a health claim of a nutraceutical product, scientific justification in the favor of ‘made claim’ is the main concern which requires supporting data to obtain marketing approval from the regulatory authorities.

Since manufacturers are involved only in the manufacturing of products, they may lack knowledge, dedicated experts and resources to initiate a clinical study.

Most common hurdles in clinical trials of nutraceutical are:

  • Study design:A pragmatic planning and design of the study involving nutraceutical products is crucial. While drafting the protocol, appropriate sample size calculation, selection of the pattern of study design (like: parallel, crossover, placebo control design), treatment allocation, endpoint biomarkers selection, and statistical techniques should be considered that have the potential to provide a proper conclusion of the study.
  • Logistic concerns:Such types of studies usually do not have pharmacokinetic endpoints, therefore more logistic concerns arise which can impact the outcomes. Even very small changes in the recruited volunteer’s life style can affect the biomarker values and in turn the study results. Therefore, proper synchronization of the recruited volunteer’s activities should be insisted.
  • Inclusion criteria: More stringent inclusion criteria (like: narrow BMI/age range, gender, race, life style) are required as compared to conventional drug based clinical studies to minimize the differences in body anatomy and physiology. Increased dedication of the volunteers is also required. This can result in more screen failures and reduced availability of eligible volunteers.
  • Trained personnel:Highly trained personnel are necessary to assure the study is conducted in compliance with the protocol requirements.
  • Sensitive methods and instruments:To analyze the samples accurately.


Sometimes, a pilot study may be conducted, to evaluate nutraceutical prior to a large scale trial to answer the therapeutic efficacy and justify the claim. Such pilot trials are observational in nature and provide the basis for progressing further.

Considering all the above challenges, opting for a CRO is the best option for a manufacturer to conduct the clinical research and it is a clear advantage to work with a CRO which has expertise to conduct clinical studies of nutraceutical without bias. To initiate a clinical study of a nutraceutical, appropriate recruitment of volunteers, logistic procedures, data handling, appropriate statistical analysis and regulatory expertise are important. A CRO is able to provide the entire service of relevant activities right from clinical trial planning, dedicated staff and professional conduct to execute, analyze the results and develop the report, all in compliance with GCP and regulatory requirements. The CROs can support the manufacturer until the regulatory approval, and also help in post-marketing studies too.

Lambda, being a well established CRO, has the expertise in planning and conduction of such studies. Many nutraceutical studies have been successfully completed. Some of the studies are rice bran oil study, fermented milk having beta glucan fiber clinical study, etc.

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