Lactulose/galactofructose, a non-absorbable sugar used as a prebiotic, is enjoying a surge in popularity. First synthesised in 1929, it has been used medically since 1957 and has found more commercial applications since then. More recently, it has come to prominence as a sought-after ingredient in a wide range of foods.
The substance is formed from the combination of two sugars, galactose and fructose. Though it derives from milk, it does not elicit the widespread intolerance associated with lactose. It appears naturally, in small amounts, in certain infant formulas (such as sterilised liquid feeds) and is added to others for its laxative properties. It is also sometimes incorporated into yogurts, juice drinks, processed foods and baked goods.
In fact, given its status as a medicine and an ingredient, it might be said to cut to the heart of what the functional food market is all about. On one hand, it features on the World Health Organization’s (WHO) List of Essential Medicines, where it is cited as one of the core medicines critical to a basic healthcare system. It is available as a generic medication at relatively low cost and is available without prescription in most countries.
On the other hand, it is known as much for its pleasant flavour and sweetening properties as it is for its pharmaceutical benefits. We are seeing a mounting wave of interest in products of this kind – ingredients that can add something from a taste or textural standpoint while demonstrably benefitting the consumer’s health.
The pros of prebiotics
The prebiotics market as a whole is going from strength to strength. According to research by Global Industry Analysts, the global market for prebiotics is expected to reach $7.8 billion by 2022, spurred by a growing interest in gut health. Long a fertile ground of scientific research, the links between intestinal flora and overall health are now becoming a matter of widespread consumer knowledge.
Not to be confused with probiotics, the ‘good bacteria’ present in the intestines, prebiotics pass through the stomach to feed these good bacteria. According to one 1995 definition, they are “non-digestible food ingredients that beneficially affect the host by selectively stimulating the growth and/or activity of one or a limited number of bacteria in the colon, which can improve host health.”
Prebiotics are used across multiple applications, including animal feed, where they are emerging as an alternative to antibiotics. However, within Europe and North America, it is the dietary supplements segment that is seeing the fastest rate of growth.
According to a report by Grand View Research, North American demand for prebiotics was valued at over $280 million last year and “prebiotic dietary supplements are expected to witness significant growth owing to [a] rising focus on preventative healthcare”.
Seek out the answer
So how might galactofructose tie into this trend? To what extent does it truly benefit health and what are some possible opportunities for manufacturers?
To answer these questions, we might start by going back to 2010, when the European Food Safety Authority (EFSA) authorised a health benefit claim based on a dossier initiated by R&D from Solvay, which was acquired by the French galactofructose supplier Groupe SOLACTIS in 2013. Specifically, it approved the claim ‘galactofructose contributes to a reduction in intestinal transit time’ when consumed at a level of 10g a day. This assessment was based on data received from EU member states and followed an approval in Belgium in 2005.
“EFSA opinion concluded that a cause and effect relationship has been established between the consumption of galactofructose and a reduction in intestinal transit time,” a spokesperson tells Ingredients Insight.
“The claim may only be used for food that contains 10g of [galactofructose] in a single qualified portion. In order to bear the claim, information shall be given to the consumer that the beneficial effect is obtained with a single serving of 10g of [it] a day.”
It should be pointed out that this is not a prebiotic claim. Groupe SOLACTIS, which markets its product as Solactis Galactofructose, does make such a claim elsewhere, stating that its product encourages “selective stimulation of the growth and activity of specific bacteria in the colon. [This] reinforces the immune defences of the body." However, while this claim has been recognised by the Korean Ministry of Food and Drug Safety (MFDS), it has not yet been supported by a European body.
In fact, EFSA has yet to approve any prebiotic or probiotic health claims for food products. Although many players in the sector have tried, none of them have been able to convince the authority that the evidence is sufficiently watertight. This means manufacturers within the EU market are somewhat restricted as to what they can tell consumers.
Of course, the fact a claim has been rejected does not mean it is untrue – it simply means there isn’t enough evidence. According to a paper published in Microbial Ecology in 2012, part of the problem is that “most intervention studies with probiotics and prebiotic studies have been conducted in patients or subjects at risk of specific diseases”. This diverges from what most prebiotic manufacturers want to state – essentially that their product can benefit healthy populations.
“Thus, the research tools have to be redirected to areas that support future health claims… based on the current regulation, the documentation for substantiation of health claims for probiotics and prebiotics is challenging but not impossible,” concluded the authors.
Groupe SOLACTIS’s transit claim, by contrast, was deemed to pass muster. EFSA formed its positive opinion by referring to seven studies, which all focused on the impact of galactofructose on transit time. In weighing the evidence, the panel noted that all these studies showed a consistently, statistically significant effect. What's more, the underlying mechanism was well understood.
As early as 1959, it was shown to be effective in regulating transit disorders through its osmotic effect. Since then, it has been used widely in the treatment of portosystemic encephalopathy and constipation. Because it is not absorbed in the small intestine like most carbohydrates, it is able to exert its full effects in the colon.
EFSA described the effect as: “[Galactofructose] as a synthetic sugar is used in the treatment of constipation. In the colon, [galactofructose] is broken down to lactic acid, and to small amounts of acetic and formic acids by the action of beta-galactosidases from colonic bacteria. This process leads to an increase in osmotic pressure and slight acidification of the colon content, causing an increase in stool water content and softening of the stools.”
While it is easy to see the benefits here for diseased individuals, it may be harder to discern why improved transit time is so important for everyone else. However, according to Groupe SOLACTIS, a regular consumption of galactofructose optimises the functioning of the intestinal tract, enhancing comfort and promoting overall well-being.
Market applications
Since the EFSA published its health claim, Groupe SOLACTIS’s product has attracted interest across multiple market sectors. These include dairy products and yogurts, where Solactis can be used in combination with probiotics; fruit-based preparations, where it can function as a zero-calorie sugar substitute; baby food; cereals and food supplements.
More recently, Groupe SOLACTIS received a new approval from EFSA: namely that “Consumption of foods/drinks containing galactofructose instead of sugars induces a lower blood glucose rise after their consumption compared with sugar-containing foods/drinks.”
Because galactofructose is not digested, it does not participate in the body’s glycaemic response and therefore helps with slow-release energy management. According to Moez Kmicha, business development manager at Groupe SOLACTIS, this may enable manufacturers to position their product as suitable for promoting weight loss.
“As an outperforming non-digestible carbohydrate, Solactis Galactofructose proposes a new health claim that will perfectly fit with applications such as high-protein yogurts, cereals bars, healthy snacking, and functional and energy waters,” he said in a release.
It is difficult to say at this stage whether or not a prebiotic claim will be forthcoming. On the 2010 opinion, EFSA stated that “a cause-and-effect relationship has not been established between the consumption of galactofructose and decreasing potentially pathogenic gastrointestinal microorganisms”. For the time being, the bar for establishing such a relationship has been set prohibitively high.
What’s more, approval by EFSA is only one part of a larger process. European law distinguishes between risk assessors of which the job is to produce scientific advice, and risk managers (such as EU member-state authorities) that are tasked with developing policies and authorising products. This means, even if a prebiotic health claim were to be approved, it would not necessarily be adopted throughout Europe.
“Decisions regarding the authorisation of health claims, including the final wording and theconditions/restrictions of use, are taken by risk managers. In order to make such decisions, risk managers may take into account other legitimate factors, such as safety aspects – to modify the conditions/restrictions of use – or consumer understanding – to modify the wording of the claim – in addition to EFSA’s scientific opinion,” explains the EFSA spokeperson.
All this said, it is clear that galactofructose holds great potential as a functional ingredient across multiple segments, improving the marketability of many products.
