How do Clinical Trials help in the success of nutraceuticals?
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.
- Estimation of product efficacy
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.
- Dose optimization
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.
- 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. The comparison can help establish a cause and effect between the nutraceutical and 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.
- Gaining consumer trust
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.
- Differentiating from other products in the market
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].