Show efficacy of the formulation, not just ingredients: Australia’s Ora Health embarks on observational trials for bestsellers
The company completed two observational studies on two of its products, Cell Protect Complex and Bright Mind Complex, in August. The latter is also supported by nine clinical trials conducted on two of its ingredients, namely Bacopa monnieri marketed under the brand BacoMind and Alpinia galanga rhizome ginger plant marketed under the brand enXtra.
Speaking to NutraIngredients-Asia, Gabriel Perera, managing director of Ora Health, said that the observational studies have showed positive results and the company would be conducting a third observational study on its other bestseller – a sleep support product marketed as Profound Sleep.
“I think the key exciting result was that the results of the studies were statistically significant. A third party did the analysis and the results were found to be statistically significant.
“Now that we've released these results to our customers, the health practitioners, in particular, are excited about it,” he said.
Although it is challenging for small brands to fund clinical trials, he believes that it is still beneficial for them to conduct observational or pilot studies to show the efficacy and effectiveness of their formulations.
This is despite the fact that his products already contain ingredients that have been validated in clinical trials.
“If you are going to produce a premium formulation and then ask the consumers to pay a premium price, I believe that the consumers deserve to know that the product will work – if they take it in the right way and ideally with the right advice.
“I think what we do in this industry is to tend to rely on the ingredient suppliers to do all the research for us. Whereas what the consumer wants is to know is whether the product with this formulation of these ingredients works.
“My aspiration is to do clinical research on all of our products, just to say that yes, we know that this stuff works, and also to include more biometric testing and quantitative testing in the new studies as well,” he said.
The findings have been released in a one-page summary to help health practitioners and consumers quickly understand the products’ benefits.
Findings
In the case of CellProtect Complex, a formulation that claims to support natural detoxification and improve energy levels among others, an open-label pilot study involving 11 healthy volunteers was conducted for 12 weeks.
During the study, the volunteers each day took two capsules of the product containing a broccoli sprout extract concentrate trademarked SIRTCell and standardised to contain precise levels of glucurophanin, myrosinase enzyme, and the bioactive component sulforaphane.
They were also required to fill out an online questionnaire that asked about the changes in their energy levels, mood, and memory during the study etc.
Findings showed that 91 per cent of them reported improvement in their energy level, while 73 per cent experienced improved mental clarity and focus. All reported a reduction in skin hyperpigmentation as well.
“We didn't expect the improvements on skin [hyperpigmentation] and one of the interesting things is that from the results, we've had an interest in distribution across APAC coming from beauty clinic distributors, who found out about the products and said that these results were exciting from a beauty point of view,” said Perera.
The formulation was initially designed as a longevity formula and supporting mitochondrial energy.
Bright Mind Complex, on the other hand, was tested on nine entrepreneurs and executives, where they took two capsules of the product daily for two months. The product contains active ingredients including Alpinia galanga rhizome extract, Bacopa monnieri whole plant extract, tulsi leaf extract, and Yerba mate leaf extract.
Similarly, they were asked to answer an online questionnaire on changes in their energy levels, mood, fatigue, stress, and the ability to think clearly during the study.
Findings showed that 89 per cent experienced an improvement in their mid-afternoon energy slump, 78 per cent experienced an overall improvement in energy and mental focus. All reported an improvement in their mental clarity.
The analysis was conducted by Dr Michael Thomsen, a naturopath and herbalist who holds a PhD from the Department of Medical Sciences at Sydney University Medical School.
“There are already nine clinical trials conducted on enXtra and BacoMind, but those were trials conducted by the ingredient owners.
“But the results were just profound in terms of 100 per cent of the participants saying that they saw an improvement in mental clarity. I wasn't expecting the results of that magnitude, which is great,” said Perera.
Sleep study
For its next step, Ora Health is planning for an observational study on its sleep support product known as Profound Sleep to take place by the end of June next year. The product is also one of the firm’s bestsellers.
Perera said that with the rise in the use of wearables, it would be easier to conduct sleep studies without sending people into a sleep laboratory.
The study, he said, would be conducted using either an Oura ring and / or with a bootstrap. The smart ring, developed by Finnish health technology firm Oura Health, is used to track sleep and physical activity.
“I personally wear the Oura ring daily, which tracks my HRV (heart rate variability), my REM (rapid eye movement) sleep, my deep sleep, and gives me quantifiable measures.
“Increasingly, people wearing the Oura ring are doing sleep studies where the data has been published in peer reviewed journals.
“But as I said earlier, I've loved to collect qualitative measures, like how you feel, and also quantitative measures from the likes of an Oura ring,” he said.
Challenges
Asked the challenges of conducting the studies, Perera said that the biggest challenge laid with the participants’ compliance. Sometimes, participants might drop out of the study because they were busy or were down with COVID-19, he said.
“That's (compliance) is one of the challenges, because we're not paying them for their time. That's the main one.
“But I think as long as you have a good kind of communication process with those people in the studies, it's going to be pretty straightforward.”
As for the study design, the firm had consulted experts to help with it.
“We consulted a couple of experts in terms of designing the study, but because there was no control group, so there's no power calculation that we took into consideration, which is why even with such small sample sizes, I was really excited to see that the results were significant.
“In layman's terms, that means effect size was great enough to show statistical significance even for such a small sample size,” he said.
