They are 1) study design, 2) study population, and 3) the dose and study duration, said Dr Welma Stonehouse, the guest of our latest Nutrachampion podcast.
Dr Stonehouse is the principal research scientist and research group leader – Nutrition and Health within Australia’s Commonwealth Scientific and Industrial Research Organisation (CSIRO) Health and Biosecurity Business Unit.
Her research focuses on the health benefits of nutritional products, including fats and oils, dairy, fish, supplements, nuts, fruit and vegetables.
One of her latest human clinical trials was conducted with industrial partners Swisse and Aker BioMarine on the benefits of krill oil supplementation on individuals suffering from mild to moderate knee osteoarthritis.
Her other ongoing research, a partnership with Hort Innovation, looks at the cholesterol lowering effects of beta-glucans from mushrooms.
Being in the research scene for the past three decades, she observed that there has been “huge progress” in the quality of human clinical trials.
“I have seen a huge amount of progress and quality of clinical trials over my 30-year career and I think some of the things that have progressed is things like the introduction of the trial registration.
“Now, good quality journals wouldn't accept any manuscript if the trial was not registered…We are definitely seeing our trials becoming bigger and longer, and more complex, involving multi-centre studies, which I think enables good quality clinical trials,” she said.
The ability to publish the findings in a high impact factor journal is also of significance, and companies are quick to boast about this when they managed to do so.
Asked the top three elements required for a clinical finding to be published in a high impact journal, she pointed out the importance of 1) study design, 2) study population, and 3) the study duration and dosage.
“There's so many things, you can probably put those [three elements] under study design, study population, and dose and duration.
“For study design, it is important to use a globally accepted gold standard methodology, the randomised placebo controlled, double-blind study if that is possible.
“And part of the study design is how do you measure the outcome, and it is really important to use valid, reliable, standardised, systems, and methods, and to consider whether the effect you are seeing is clinically meaningful.”
Firms still deterred by cost, time commitment
Nonetheless, nutraceutical firms are still deterred by cost and time commitments, Dr Stonehouse observed.
“I can't speak on behalf of the companies, but what I have observed in the food and nutraceutical space, is a reluctance to invest in quality clinical trials due to cost and the time it takes to deliver these clinical trials and not many nutraceutical companies have taken the route that Swisse has taken in terms of committing to developing and building that science and evidence behind some of their products.
“Sometimes, companies' strategies change, by the time the clinical trial is done, the strategy has changed, I think they are looking for ways to get evidence quicker and I guess that is also a limitation,” she added.
Some companies are also concerned that their published trial findings might be used by competitors to market their products, which in turn dampens their interest to invest in a trial, she pointed.
In this case, she pointed out that Australia has introduced regulations to protect new clinical trial information for a period of five years under the assessed listed (AUST-L(A) medicines pathway.
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