What are Food and Nutraceuticals?
‘Nutraceuticals’ is a composite term of ‘nutrition’ and ‘pharmaceutical’. They are a blend of products that possess both nutritional as well as medicinal value. They are designed to improve physical health, boost immunity, and deal with stress and increase longevity.
Nutraceutical products play a significant role in maintaining normal physiological function in healthy human beings and provide protection against chronic diseases. Changing lifestyle and evolving health trends among the general populace has allowed for the growth of the global nutraceutical market. They significantly help in combating some of the major health problems such as obesity, cardiovascular diseases, cancer, osteoporosis, arthritis, diabetes, cholesterol, etc. Nutraceuticals have led to the new era of medicine, in which the food industry has transformed into a research-oriented sector.
Why Nutraceuticals are Gaining Traction Today?
Most of the nutraceutical products have high antioxidant activity and are considered healthy sources for the prevention of life-threatening diseases. Nutraceutical and food ingredient manufacturers are progressively looking to market their products by demonstrating unique health benefits.
There are many generic, widely used claims – in the EU, Article 13.1 of the European Food Safety Authority’s (EFSA) EC Regulation permits manufacturers to use some 4,637 that pertains to vitamin and mineral content.  This proliferation of generic claims and increased competition is driving manufacturers to develop more unique selling propositions (USPs) to use in marketing efforts, which has led to significant growth in demand for nutraceutical trials.
In the United States, nutraceutical products are regulated as drugs, dietary supplements and food ingredients. The term varies from one country to the other, however, it is usually defined as a “product isolated from foods that are generally sold in medicinal forms”. The demand for nutraceuticals continues to increase due to their potential nutritional, safety, and therapeutic properties. Market research recently proposed that the worldwide market is expanding and would reach the US $250 billion by 2018. 
Challenges of Nutraceutical Trial Designs
Nutraceutical trial design demonstrates several unique challenges for researchers. As the market is continuously evolving, many companies in this sector are still unfamiliar with clinical trial designs.
There are several reasons for this:
- There is relatively less incentive as broader claims about an ingredient may already exist.
- Deriving data and claims from previously completed research are possible if a product’s active ingredients are the same.
- Food and ingredients manufacturers often have a very low budget devoted to trials.
- The health effects of nutraceuticals are often minimal compared to pharmaceutical products and are more easily affected by the heterogeneity of subjects, environmental and lifestyle factors such as drinking, smoking, physical activity, etc.
- Larger sample sizes are required to conduct a viable study compared to a normal drug trial.
- It is not easy to finalize on an end-point and establish what claims sponsors want to make in a nutraceutical trial.  It is in sponsors’ benefit if they choose their claims for which they want to gather the evidence before commencing a full trial.
- To conduct a pilot study to gain insights into desired end results creates an additional cost for sponsors.
- Subjects are difficult to recruit for these clinical trials and they have higher drop-out rates than pharmaceutical counterparts as the study group must maintain a healthy lifestyle and record more related information.
Strategies for Effective Nutraceutical Trial Design
The challenges associated with nutraceutical studies are complex, however, they can be managed with a structured and effective trial design.
Apply Surrogate Markers
In order to prove a specific product has preventive qualities, a significant amount of data is required, making the trial run over a longer period. To contradict this, sponsors can use a surrogate marker which must be suitable, reliable and consumers will need to acknowledge it as an appropriate surrogate. For example, instead of claiming that a product ‘lowers the risk of strokes or heart attacks, the surrogate claim is that a product ‘reduces levels of bad cholesterol associated with increased risk of strokes and heart attacks.’ 
Uncontrolled Vs. Controlled
Whether a trial will be controlled or uncontrolled is totally dependent on the type of product, the desired end-point, and any logistical or budgetary constraints. Trials should include a reference group where a nutraceutical can ideally be compared against a placebo. People often change their behavior and lifestyle when they are being monitored for a trial, so without a reference (control) group, it is impossible to understand whether changes observed in people taking the nutraceutical are a result of the product or any other factor.
Open-Label Vs. Blinded
Lifestyle choices reasonably influence the end-point in a trial and so it is vital to double-blind, as the knowledge of whether the subjects are taking the active component will change their behavior and so bias the result. Double-blinded trials are the gold standard where placebos are used and should be used where possible.
When it is not possible to design a suitable placebo, an open-label approach would be adopted. This is usually undesirable as compliance to the study protocol is likely to be inferior in placebo groups when participants know they are not taking the active product and sometimes may withdraw from the study as they have no incentive to continue. There are also issues with bias as participants are unlikely to perceive any improvement in their health condition if they know they are taking a placebo, whereas participants who know they are receiving the active ingredient (product) may perceive an improvement whether there is one or not.
Lifestyle patterns often have a bigger influence on a nutraceutical than a drug and a more significant impact on the outcome of the trial. For this reason, it is essential that the study design acknowledges lifestyle variables and ensures these are effectively recorded and factored in to the final statistical analysis.
Selection of strict participant inclusion and exclusion criteria is vital here as an effect of the nutraceutical in the selected subjects needs to be achievable and evidenced in the trial.  As with a pharmaceutical study, subjects need to start off with symptoms severe enough that an improvement can be seen. 
The study data needs to be as generable as possible and the results need to show that a nutraceutical could have a substantial effect on a wider population.
A balance needs to be achieved so that the study population is homogeneous enough to see a result. Running the trial from different centers ensures sponsors can capture more diverse demographic and environmental issues and that the subsequent data is more consistent and reliable.
How We Help Clients:
We at Techsol have highly experienced functional teams to conduct nutraceutical trials, right from the study design to commercialization. We have qualified procedures in place for appropriate recruitment, sample and data handling, and skilled statisticians for protocol planning and data analysis. With our expert team we provide the following services:
- Study Protocol design
- Sample Size Calculation
- Study Database / electronic case report form (eCRF) Design
- Identification of Primary and secondary data points that are ideal for statistical calculations
- End-to-end Clinical Trial Management
- Subject Recruitment and Retention strategies
- Study Data Management
- Clinical Data Statistical Analysis
- Preparation and Submission of Final Clinical Study Reports
If you would like support on nutraceutical trials, please reach out to us at email@example.com.
- European Food Safety Authority. (2012, August 7). “General function” health claims under Article 13. https://www.efsa.europa.eu/en/topics/topic/general-function-health-claims-under-article-13
- Statistical Consultancy Team. (2018). Nutraceutical trials: demand, design and challenges. Quanticate. Retrieved 2021, from https://www.quanticate.com/blog/nutraceutical-trials-design
- The trial of nutraceuticals. (2018). The Trial of Nutraceuticals. https://www.nutraceuticalbusinessreview.com/news/article_page/The_trial_of_nutraceuticals/144753
- NCBI – WWW Error Blocked Diagnostic. (2014). NCBI. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4336979/