World-Way Biotech Inc.

Challenges with clinical trials for natural extarcts

Click:734  Time:2019-05-24 16:24:00

Natural extract are usually plants extract This means that they contain a multitude of constituents one or several of which are active compounds that can be linked to a health effect. Often though it is unknown which of the components in an extract is responsible for the observed health benefit. Often there is not one single substance that has a health effect. Often, there is not one single health effect. This is due to the synergistic effect of the biological matrix that is present in plants removing the matrix by e.g. Isolating a single active compound and studying it by itself often results in a lesser health benefit than what is observed for the whole extract. Also, and this is an issue especially in the EU. Isolated plant substance run a risk of being considered novel food. Or of being considered pharmacological substances.


Clinical trials made to support health effects of extract that are intended for use in the food industry need to be conducted on a healthy population, EU legislation in particular makes a strong distinction between food and drug. A food by nature can not cure or prevent a disease therefore health effects can only be claimed if no disease is present in the trial population.


In many cases therefore, the effect size that can be expected for natural extract is small, If the study population is healthy to begin with, the only effect that can be observed is the improvement of certain sub-clinical conditions, e.g. high cholesterol or high blood pressure. Studies on herbal drug do not have this limitation, since their efficacy can be substantiated on patients with a disease that can actually be alleviated or even cured


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