Clinical Trial Challenges for Dietary Supplements
The term ‘dietary’ supplements is a broad one that includes nutraceuticals and nutrition supplements. ‘Nutraceuticals’ is coined by merging the terms ‘nutrition’ and ’pharmaceuticals’. They contain modified/unmodified whole food or plant extracts, separately or combined. They may also contain semi-purified and purified phytochemicals or a blend of various types of phytochemicals. On the other hand, nutritional supplements increase one’s total dietary nutrient intake. Nutritional supplements may contain substances alone or fortified with vitamins and minerals, herbal products, with or without animal-based substances like glucosamine or probiotics. They are known by various names in different countries. For instance, they are called Natural Health Products (NHPs) in Canada.
Dietary supplements have gained popularity among consumers since they offer numerous health benefits and supplement their nutritional requirements. However, the regulatory agencies must thoroughly assess their safety and efficacy before they can be launched. Clinical trials help determine the safety and efficacy of these products.
Check out our blog on how clinical trials contribute to the success of nutraceuticals to know more about the role of clinical trials.
Challenges of clinical trials in nutraceuticals and nutritional supplements.
Clinical trials play a vital role in nutraceuticals’ success. However, nutrition and nutraceutical companies often face challenges while conducting clinical trials. The following section discusses the various challenges during the process.
- Lack of Authoritative control
There is less quality control while sourcing raw materials and assessing the compounds. The potential interaction between the nutraceuticals’ components also should not be ignored. For instance, the combination of ginseng and caffeine sold in energy drinks led to a subsequent recall since it may have a harmful effect on the body. To address this challenge, nutrition companies must seek to follow standardised procedures like Good Manufacturing Practices (GMP). Steps must also be taken to reduce contamination by microbes, pesticides and heavy metals.
- Financial constraints
Compared to pharmaceutical products, the health effects of nutraceuticals are few. Moreover, the effects are highly variable, depending on the participants’ demographic features and environmental factors. Therefore, a larger sample is required, which necessitates more resources. Nutraceutical companies need more finances to make the study viable.
- Maintaining the quality of nutraceuticals
Maintaining the quality of nutraceuticals is challenging since the ingredients for nutraceuticals may vary significantly depending on the season and geographical area. If the same ingredient is used, it may differ in the concentration of bioactive compounds that exert the effect.
- Selecting biomarkers
Choosing appropriate biomarkers for determining the effects of nutraceuticals can be challenging since nutraceutical products exert multiple effects. Selecting a suitable biomarker may not be established.
- Determination of long-term effects
Nutraceuticals are sold and marketed for long-term health effects, but designing and conducting long-term clinical trials can be challenging since they require many resources. Conducting studies for the short term may not give an idea of the health effects.
- Nutraceutical compliance and adherence
Participants must comply and adhere to the instructions regarding nutraceuticals for their effects to be observed. Since nutraceuticals must be taken daily for extended periods, maintaining compliance can be challenging. If a participant is not compliant, the results may show inaccuracies.
- Regulatory challenges
Nutraceutical products are regulated less stringently than pharmaceuticals. This can cause variations in the product’s quality, purity and composition, making it difficult to maintain consistent quality between different batches. Also, there are differences in the regulations between various international regulatory bodies, which is a challenge in ensuring product quality [1].
Conclusion
Dietary supplements are a broad term that includes nutraceuticals and nutritional supplements. They must undergo clinical trials to ensure the product’s safety and efficacy. There are some challenges of clinical trials which the companies must recognise and try to address. They include lack of authoritative control, financial constraints, product quality maintenance, biomarkers selection, long-term effects, participant compliance and adherence and challenges in the regulatory environment. Seeking the help of a consultant may help address the challenges.
How the Food Research Lab can help
At the Food Research Lab, we are a team of experts who offer assistance with formulating nutraceutical products. We help with choosing the right ingredients, formulation and regulatory compliance. We also help with clinical trials and ensure the products are safe and effective. Moreover, we assist with product labelling, ensuring the products are successful in today’s highly competitive market.
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