How do clinical trials contribute to the success of nutraceuticals

1. HOW DO CLINICAL TRIALS CONTRIBUTE TO THE SUCCESS OF NUTRACEUTICALS? An Academic presentation by Dr. Nancy Agnes, Head, Technical Operations, FoodResearchLab Group:  www.foodresearchlab.com Email: info@foodresearchlab.com

2. What are clinical trials? • According to the World Health Organization, clinical trials are a type of research that investigates new tests and treatments and assesses their effects on human health. • A new medicine, diet or medical device can be tested in a clinical trial for its safety and efficacy. • Sometimes, clinical trials are conducted to determine whether a new line of intervention is more effective or has fewer side effects than existing treatment. • Nutraceuticals and functional foods are also required to undergo clinical trials to determine their safety and efficacy and serve as proof for their health claims.

3. Evidence on the safety aspects of sugar replacers How do Clinical Trials help in the success of nutraceuticals? • Clinical trials must be conducted on a large scale to generate accurate clinical data, which includes the safety and effectiveness of a product. • Clinical data helps nutrition and nutraceutical companies gain trust among the general public and the medical community. In addition, clinical trials also help determine the optimum dose of a nutraceutical product that exerts the desired therapeutic effect and is safe for consumption. • The importance of clinical trials for the success of nutraceutical products is as follows: • Assessment of Safety: Nutraceutical products contain bioactive compounds which can interact with the body in several ways. Clinical trials aid in the identification of any potential side effects or risks associated with their usage. This is necessary to ensure the product does not harm people who consume it, especially in long-term usage. Cont.

5. Estimation of product efficacy • Dose optimization Clinical trials provide scientific evidence about the product's efficacy. They help to decide if a product offers its claimed health benefits. The efficacy of a nutraceutical is unknown without conducting clinical trials, and consumers may not realize the benefits of the nutraceutical products. Clinical trials help determine the optimum dose for nutraceutical products to achieve the intended health outcomes. The correct dosage is critical to ensure the effectiveness of the product without causing any adverse reaction. Cont.

6. Ruling out the placebo effect Researchers can do a comparison study of the nutraceutical with placebo and can ascertain whether the effect is due to the nutraceutical and not due to placebo. • Scientific credibility Nutraceutical products gain scientific credibility through clinical trials. A rigorous study incorporating suitable techniques, randomization, blinding, and statistical analysis gives credibility to the product's claims, like the health claims of botanical nutraceuticals in the EU. • Approval by regulatory bodies International regulatory bodies, such as the Food and Drug Administration (FDA) and the European Food Safety Authority (EFSA), require evidence of safety and efficacy from clinical trials before approval for the marketing and selling of nutraceutical products. A nutraceutical product will not be permitted to be sold as a health-promoting product without evidence from clinical trials.

7. Gaining consumer trust • Differentiating from other products in the market Clinical trial outcomes may build trust in healthcare practitioners and consumers. Healthcare practitioners are more likely to recommend a nutraceutical formulation that has solid clinical evidence, and people are more likely to trust and buy products that have been tested by rigorous trials. The nutraceutical sector is frequently flooded with products that make distinct health claims. Clinical trials give a nutraceutical product a competitive edge by distinguishing it as having proven benefits, resulting in greater sales and market share [1]. Cont.

8. CONCLUSION • Clinical trials necessitate studying a medicine, diet or device on human subjects and have included studying nutraceuticals for their effects, including their benefits and adverse effects. • They help assess the safety and efficacy, optimize the dose, rule out the placebo effect, gain consumer trust and approval from regulatory authorities and differentiate from other products in the market. • These factors contribute to enhanced sales and subsequent success of the product.

9. HOW THE FOOD RESEARCH LAB CAN HELP • Our team comprises food technologists, scientists and experts who offer clinical trial management services. • We understand the importance of clinical trials, for they are cornerstones for nutraceuticals to comply with the regulations and the overall sales in the highly competitive market. • We also conduct bioavailability and pharmacokinetic studies that help bring credibility to the products, guaranteeing their success.

10. Contact Us UNITED KINGDOM +44- 161 818 4656 INDIA +91 9566299022 EMAIL info@foodresearchlab.com