Gut microbiome, blood glucose clinical trials most requested among Japan’s FFC producers
Foods with Function Claims (FFC) is a unique feature of Japan’s foods with health claims system.
The system also consists of Foods for Specified Health Uses (FOSHU) and Foods with Nutrient Function Claims (FNFC).
In particular, FFC can make a specific health claim so long as it is backed by evidence from systematic review (SR) or clinical trials.
The information will also need to be notified to the Consumer Affairs Agency (CAA) which oversees these products.
According to Tokyo-based KSO Corporation, which has conducted clinical trials on FFC for various industry big names like Kirin Holdings, Kagome, Fujifilm, Ajinomoto, Kewpie, Suntory, and Meiji, studies on the gut microbiome and blood glucose management are the most commonly requested ones.
“There is a trend in clinical trials conducted on FFC, and the requests change each time. However, the most common tests that are requested every year are gut microbiome tests and blood glucose tests.
“There is hardly a time when these tests are not being conducted,” said Mika Komori, founder and CEO of KSO.
A study conducted by the company and funded by Meiji, for instance, examined how the supplementation of Lactiplantibacillus plantarum OLL2712 could improve glucose metabolism.
Findings were published in Diabetes, Obesity and Metabolism in March this year.
As for gut microbiome, while probiotics is a popular candidate, other key ingredients that are studied include dietary fibre such as resistant starch, pine starch, non-digestible dextrin, or the combination of dietary fibre and lactic acid bacteria.
Other candidates include oligosaccharides, the microalgae euglena, the botanical Terminalia bellirica which is mostly used in ayurvedic medicine, and fucoidan.
Only about 10 per cent of the companies making FFC have conducted clinical trials on their products, Komori pointed out.
Most of these are large companies that have the resources to do so, and this will most likely remain as the trend moving forward.
As of October 1, there were a total of 8,847 FFC notified to the CAA, according to its online search platform. The figure is an accumulation since April 2015 when the FFC framework was first introduced.
“It is not easy to suddenly request a clinical trial by medium-sized companies due to the lack of people, money, and experience. Therefore, large companies with resources, such as materials, patents, and research, are expected to be the main filers for a while,” said Komori.
Healthy ageing related trials rank next
The next most conducted clinical trials are those related to visceral fat reduction as well as healthy ageing, such as supporting joint and cognitive health.
Giving the example of Ajinomoto, Komori said her company has conducted a trial on a product containing seven essential amino acids for cognitive health.
This mixture of amino acids can be found in Ajinomoto’s FFC product known as No-katsu Seven Amino launched in 2021.
This product is said to have “leveraged the effects of the seven essential amino acids to maintain attention and retain cognitive flexibility, two cognitive functions that decline with age. This product also supports positive feelings,” according to a report by Ajinomoto.
As for visceral fat reduction, one of the trials conducted was a study on how the supplementation of the amino acid arginine, alanine, and phenylalanine at a total of 1,500mg per day for 12 weeks could reduce abdominal total fat area.
Findings of the study which involved Meiji, were published on Diabetes, Metabolic Syndrome and Obesity in 2018.
On the other hand, clinical trials related to immunity and fatigue have also increased in recent years due to COVID-19.
“The tests that have been increasing over the past few years are immune tests, fatigue or stress system of the body and brain, and locomotive tests such as walking tests,” said Komori.
An example is Kirin Holding’s Lactococcus lactis strain Plasma, also known as LC-plasma, which has been studied for its immune support function.
Systematic review
Small and medium-sized companies are likely to stick with using systematic review to back up their FFC claims due to a constraint in their resources.
It is also common for these companies to engage OEM companies in manufacturing and preparing systematic review data for their FFC notifications, said Komori.
“Small and medium-sized companies lack the expertise and funds to research new materials in-house, conduct clinical trials, and file functional food labelling notifications, and only a few companies also manufacture their products.
“Companies that manufacture products, known as OEM companies, prepare materials for FFC notification in SR. Small and medium-sized companies often use the materials after purchasing functional substances from them to submit to the Consumer Affairs Agency for permission, so SR submissions by small and medium-sized companies are more common,” said Komori.
However, this is not necessarily an easier way forward, since standards for systematic reviews have raised in the aftermath of the red yeast rice saga.
“Various professional organisations frequently send information sessions on how SR should be conducted.
“According to these sessions, the level of SR papers has been raised considerably, and the hurdles for submitting new SRs in the future have been raised significantly, so SR notifications will be expected to decrease,” she said.
One of the plans that the CAA had previously announced, was for systematic reviews to be prepared according to PRISMA 2020, instead of PRISMA 2009.
The 2020 version has included new reporting guidelines to reflect advances in the methods used to identify the studies.
Known as Preferred Reporting Items for Systematic Reviews and Meta-Analysis, PRISMA is an international guideline that sets out the information that should be present in systematic reviews.
