This is according to an expert panel which debated on the topic ‘Clinical Research and Immunity in APAC’ at the NutraIngredients Immunity Webinar Series. (Listen on demand here)
The panel consisted of Gencor Pacific’s CEO Ramasamy Venkatesh, Dr Olivier Gasser from the Malaghan Institute of Medical Research’s Translational Immunology department, Prof Luis Vitetta, the adjunct professor at the University of Sydney’s medical school, and Amit Srivastava, the founder of Responsible Nutrition Association of India.
The discussion was hosted by Gary Scattergood, editor-in-chief of NutraIngredients-Asia.
When asked about the quality of nutrition research in APAC, Venkatesh responded that researchers had followed good practices such as having a clearly defined study objectives and a robust methodology.
“In my opinion, the quality of clinical trials in the nutrition industry, not only those relating to immunity studies, has been improving and growing by leaps and bounds for the last few years,” he said.
This was a departure from past research when sample sizes were low, study endpoints were not defined clearly and researchers resorted to using statistics to tease out a result from the data, he said.
Agreeing that significant improvements were seen, Prof Vitetta added that researchers should avoid pitfalls such as biases arising from the randomisation process, measurement of the outcomes, and/or missing outcome data, as well as deviations from the intended intervention.
“Biased judgement, as far as I am concerned, produces a serious signalling question in each of the biased domains that can actually critically underpin how good this study will be or will not be with respect to achieving the primary and secondary endpoints,” he said.
From a commercial point of view, good scientific evidence that meets market needs can in turn lead to successful product sales.
“I believe scientific endeavour and business needs both go hand-in-hand. There is a need to understand the target market to design the trials.
“As long as the science is strong and realistic, and it captures a group of people who are going to benefit from the product, yes, that's going to benefit and drive sales,” Venkatesh said.
In the upcoming month, the NutraIngredients global team will host another 11 webinars covering topics on the immunity and microbiome, botanicals, and active nutrition across APAC, EMEA, and Americas.
All webinars will be available to view after their broadcast date as ‘on demand presentations’ until Sep 25.
The next one in APAC takes place on June 3 and will focus on ‘Immunity and the Microbiome’.
Full acceleration of trials
Clinical trials related to COVID-19 are now the key focus for many countries.
Citing the case of India, Srivastava said that the Ministry of AYUSH had rolled out a series of studies and was planning to recruit one million subjects.
“There has been a full acceleration in driving quality research.
“This act [from AYUSH] itself is sending out a very clear message to the industry within India as well as outside of India that clinical studies, qualitative research is the clear way forward,” he said.
For Gencor Pacific, the firm’s next study the effectiveness of Levagen+, its patented palmitoylethanolamide (PEA) formula, in reducing upper respiratory tract infections in Australia’s adults during winter.
The trial will build on the existing findings on the compound which was first found to be effective in treating influenza in 1973 via clinical trials, Venkatesh pointed out.
Other upcoming clinical studies involving Levagen+ will assess its effects on sleep, migraine, headache, acute joint pain, and allergic rhinitis.
Becoming flexible
At the other end of the spectrum, many non-COVID-19 clinical trials have come to a standstill and researchers will need to adapt.
“There is already significant impact on our programme…We have pushed everything back. We just need to be flexible,” said Dr Gasser.
Representing the Malaghan Institute of Medical Research at the country’s High-Value Nutrition Science Challenge (NZHVN), he said there were plans to study how nutrition from food could reduce lung inflammation.
The trial will target the population staying in Jakarta. There is also another trial studying the link between obesity and asthma in New Zealand.
These trials will build up on the existing nutrition and immune research that the organisation has been doing, such as the food-microbiota axis as a lung-intrinsic immune adjuvant.
A virtual clinical trial, on the other hand, might not be a suitable option in some cases.
“I think I want to finish what we have got going and then see what comes out of that…virtual research at the moment is beyond what I have been thinking about,” Prof Vitetta said when commenting on the clinical trials involving probiotics as an adjunctive medicine.
