Finding a sweet spot in researching gut health ingredients without crossing regulatory boundaries can be a challenge. Probiotic ingredient supplier Ganeden Biotech seems to have found one way around this conundrum by using healthy seniors as a study population.
Ganeden, based in Mayfield Heights, OH, has developed a proprietary strain of bacillus coagulans, branded as BC30. The strain is unusual among probiotic ingredients on the market in that it is a spore forming organism, making it highly stable at room temperature and able to take the heat of processing and even baking. This property led Ganeden to concentrate on the functional food market and sell the supplements side of the business to Schiff Nutrition, now part of Reckitt Benckiser. Ganeden now has placed BC30 in a wide range of food products from yogurt to beverages, prepared foods and even baked goods and confectionary goods.
Study design issues
While the inclusion of probiotics has become a strong selling point in a variety of foods, the ingredients themselves can be challenging to back up with science because of the finicky nature of study design. It can be difficult to find a way to study the effect of these organisms without looking at a set of subjects that already have gut health problems, who are diseased, in fact.
But looking at older study participants proved to be a way to kill two birds with one stone, as it turns out. The healthy aging market is big, and only going to get bigger, so functional food formulators are actively seeking new products for this market, said Erin Miller, marketing manager for Ganeden.
“Because of the growing senior market and baby boomers becoming seniors and their need to live healthier, longer lives and all the disposable income they have, we’ve noticed a growth and need from our partners for research into this demographic and that’s how we started with this research,” Miller told FoodNavigator-USA.
And the population gave a ready-made end point for a study, getting around the problems endemic to the research into the use of these organisms as dietary supplements.
“We’ve done a lot of work around BC30 in general and have shown that it supports digestive and immune health,” said David Keller, vice president of scientific operations for Ganeden. “But how do you study digestive health in a healthy population? It has been something that the industry has been struggling with and there really isn’t a good model out there as of yet.
“You can take a stressed person that technically not sick, and measure some end points like days off of work. But generally when it comes to digestive health you typically have to pick an endpoint that is related to disease, whether it is IBS or some other dysfunction in the digestive system,” Keller said. “Occasionally you see some people do it with travelers suffering from traveler’s diarrhea, but the question then becomes how do you correlate that to the general population?
“We chose a senior population that has had a decline in their general digestives and general immune health. Not because of any disease conditions but generally just due to aging. It was an ideal population to study,” he said.
Gut health in its infancy
Keller noted that the study of gut health is still in its infancy. Recent research has helped lay out the general characteristics of the gut microbiome, and has even posited that humans’ gut microflora might fall into several broad families or “enterotypes.” But Keller said it’s too early to be able to say with certainty what that information means in terms of overall health.
“The issue right now is even if you do have that data, what does it mean? We do studies to prove efficacy in our subjects that are linked of measurable endpoints. This latest study with seniors supports what we already know about BC30,” he said.