12,886 clinical studies on ‘dietary supplements’, have been observed to substantiate some widely declared health claims from 1990 to 2022, as per the Clinical Trials.Gov registry in Oct 2022. Strains are identified to mimic the gut microbiome and we have not even explored beyond 3% of the total intestinal microflora.
With the rise of NPD, Clinical trials have kicked off with some uniquely designed health claims with innovative product development now in place. Sleep and mood alterations linked to gut dysbiosis, cognition controlled by prebiotic strains, and anxiety connected with changes in vaginal flora – NPD has propelled preclinical and human clinical trials. But while you are deciding on the next study, how would you ensure the investment made in a study leads to exponential marketing and maximises the results generated?
Here is a stepwise approach that is advised:
- Go for a pilot study: Exploratory studies can be designed to examine several doses, types of consumer groups and measurement time points, as well as more than one clinical outcome.
- Plan for 2, not one study: Keep different study sample size, one proof of concept and another would be confirmatory. Initial setup costs for several activities, such as documentation, site setup, trial supplies, etc., can be significantly reduced when both studies are planned together
- Statistically design sample size: they can drive the key to the study success – past literature and the product’s own preclinical data can assist in GAP analysis. Opting for 90 volunteers if statistics state the same, instead of 100 can be a significant cost saver.
- Choose your CRO carefully: Opt for a CRO that can initiate all its sites together with a recruitment speed of 8 / week / site or more. CROs in India can offer IRB submissions with 2-3 weeks of TAT. Plus, they offer a diverse population with varied dietary habits – this ensures that the ingredient can show its effect on supplement-naïve population, making the data universally accepted.
- Test item manufacturing: Major hurdle lies in manufacturing and shipping the test material. Ask the CMO to deliver the product while the study is about to be signed. This ensures you can ship the material well immediately the study is agreed upon.
- 3-way parallel operations: Once the study is signed, initiate your documentation, Ethics Committe submissions and the capsule shipment (if study is done abroad) all together. That enables the study duration to considerably reduce and the study operations to begin almost 8-12 weeks of the study signing.
Vedic Lifesciences is a CRO in India providing clinical and preclinical research services for substantiating advertising claims for food supplements and functional ingredients. They are serving large global brands, as well as start-ups in diverse dietary supplement health categories worldwide for more than two decades.