The company says that the ingredient, which was granted a U.S. patent in 2023, has been shown to significantly decrease the occurrence and severity of the common cold within seven days, as supported by research published in the International Journal of Basic & Clinical Pharmacology.
The randomized, parallel, double-blind, placebo-controlled clinical trial evaluated the effects of supplementation in 120 healthy subjects who had experienced upper respiratory tract symptoms in the two months prior to enrollment in the study. Findings indicated that symptoms decreased by more than 80% as compared to over 30% in the placebo group.
Additionally, serum Immunoglobulin G (IgG) increased by over 12% versus nearly a 5% decrease for the placebo. C-reactive protein (a measure of inflammatory response) decreased by approximately 47% as compared to about a 10% increase in the control group.
"For the first time to my knowledge, a safe plant-based product has been shown to improve this immunoglobulin shield,” said Dr. Frank Lichtenberger, immunologist and scientific advisor at Karallief, in a statement. "In our modern era of rampant human-to-human contagion, bolstering our immune defenses is vital, making this product particularly exciting."
The ingredient works when taken before symptoms appear, which Krishna Rajendran, CEO of Karallief, said aligns with the post-pandemic focus on taking a proactive approach to health and consumer interest in clinical evidence.
“KaraShield helps support a healthy immune system which keeps you safe and secure throughout the winter,” he told NutraIngredients-USA. “You’re giving the right nutrition to the body to help build it before it needs to act.”
A critical synergy
It took three years to develop KaraShield, which is comprised of plant species Andrographis Paniculata, Withania Somnifera, Moringa Oleifera and Ocimum Sanctum. Rajendran said most of the nutraceutical products on the market are single ingredients and do not tap into the synergy that exists in nature when different extracts are combined.
“I could give you a perfect scientific explanation, but the truth is that's the beauty of nature,” he added. “Sometimes we don't even know why these four [plants] work well.”
Unlike pharmaceutical companies who are often tasked with identifying a specific compound and mechanism of action, companies in the supplement space are faced with sorting through thousands of compounds found in nature—a sorting that can become daunting, Rajendran said.
“We've identified a few key compounds which may be responsible for the synergy,” he explained. “But to definitively say ‘this is the single key compound’ is not really true. We can identify major compounds which may be responsible, but there are so many compounds at play.”
Since the company is able to identify which plants are effective as a whole and not necessarily pinpoint a specific compound in each, the KaraShield patent is based on the composition, or ratio, of the blend.
"That's why we do a lot of experiments to see which one gives the best result," Rajendran added. "And how do we select the initial group of plants? My scientific team has more than 30 years of experience just developing products based on plant extracts."
Condition-specific supplements?
KaraShield targets general cold symptoms rather than a specific condition, and Rajendran said that the company could focus on particular conditions in the future but understands the associated challenges.
"When you get into condition-specific immunity, for example, you're going to have to talk a lot about the condition, and right now regulations do not allow for that," he said. "For example, if a proactive product was developed for a specific condition, even if it was a great product, it would be difficult to raise awareness and talk about it due to regulatory restrictions. Maybe things could change in the future if there is a way to bridge the gap."
In terms of when formulations with KaraShield will be available on the market, Karallief said that it is working with manufacturers who are evaluating the ingredient, with the first finished products expected to launch by September, just before the onset of winter.