Nutraceuticals play a unique role in contributing to health and protecting against illnesses outside the traditional scope of drugs. Coined as a combination of ‘nutrition’ and ‘pharmaceuticals’, the term ‘nutraceuticals’ refers to a wide range of overlapping products – usually derived from a food source – that have potential physiological benefits.
By adding on to the basic nutritional value consumed in food, nutraceuticals and dietary supplements increase life expectancy, support the functions and integrity of the body, and even contribute to the treatment of disease. For example, omega-3 fatty acids can decrease glucose intolerance in patients inclined to diabetes. Meanwhile, nutraceutical antioxidants such as curcumin, lutein and lycopene can combat oxidative stress.
Taking nutraceuticals to market
Dietary supplements are regulated somewhat differently from drugs, as they usually do not fall within the same strict regulatory framework as pharmaceuticals. For example, in most countries, nutraceuticals do not require FDA approval. This means that bringing a nutraceutical product to market may take less time than medicines and drugs, yet this does not exclude a manufacturer from needing to conduct clinical studies.
In some jurisdictions, the manufacturer of a nutraceutical must ensure that a product is safe and free of contaminants before it can be offered to the general public. Manufacturers may also want to get ahead of the competition by substantiating marketed claims with scientific evidence.
What happens in a clinical trial for nutraceuticals?
Clinical trials can help sponsors to meet these requirements by providing proof of a nutraceutical’s performance. A trial evaluates the safety, efficacy, and bioavailability of nutraceuticals – the latter of which measures the extent and rate at which the nutraceutical is absorbed into the body.
Some studies can evaluate a single agent, while others assess an entire product’s effect on the person taking it. Nonetheless, preclinical studies are usually helpful in establishing preliminary levels of safety and bioavailability in a product, thereby increasing the chance of a successful clinical trial.
Clinical trial design will vary depending on the biomarkers and endpoints chosen by sponsors. The study population for a nutraceutical clinical trial might be a targeted population, such as women, athletes, or the elderly. In cases where the clinical trial aims to establish the product’s efficacy on the general population, the study needs healthy volunteers of both sexes, covering a broad range of ages.
The focus of a trial can include disease modification, disease recovery, and other endpoints based on various biomarkers. Meanwhile, trials that incorporate a dosage performance assessment can also test whether a dietary supplement tablet or liquid gel capsule can disintegrate in the stomach and release its contents.
Trials should also include a comparator group, where the nutraceutical being assessed is compared to a placebo – or a standard method of care or medication. Often, double-blind trials are the best option.
Overcoming the unique challenges of nutraceutical clinical studies
Due to their multiple functions, nutraceuticals often face challenges not usually found in pharmaceutical clinical studies.
With many potential benefits available in a nutraceutical product, it can be difficult to pick endpoints and biomarkers to study. Moreover, having a reliable biomarker on the biological endpoint of interest is essential to a successful clinical trial. As a result, these clinical trials often need a pilot study to gain insight into desired end results, which doubles the cost and time spent.
While dietary supplements and other nutraceuticals contain natural agents found in commonly consumed foods, the clinical trials used to assess them must meet high standards of design. Firstly, a trial must enforce quality control in order to ensure each batch of tested product contains a consistent level of active ingredients. Additionally, clinical trials for dietary supplements require larger sample sizes than drug trials, yet achieve as low a standard deviation as possible.
Lifestyle choices should also be taken into account, as they have a bigger influence on the outcome of nutraceuticals. This is because the health effects of nutraceuticals are often minimal when compared to pharmaceuticals, and are easily affected by environmental factors. These strict requirements often lead to compounded difficulties in recruitment.
Nutraceutical trials can also experience higher dropout rates than those of pharmaceutical trials. Demands on participants might be higher, such as having to maintain a healthy lifestyle or being asked to record more information in order to gather significant amounts of data. This can lead to difficulties in retaining patients.
However, these obstacles can be overcome through effective trial design and good management. Clinical research organizations (CROs) draw from extensive experience to utilize tried-and-tested mechanisms that have led to success in both the pharmaceutical sector and the nutraceutical industry.
Clinixir’s industry-leading services help your organization simplify your clinical trials, making them less time-consuming and more cost-efficient. We also have access to a large patient pool, and are able to connect you to advanced networks and technologies to facilitate a smooth transition to market.
Contact us today to get started.