The research, which was funded by Karallief, was conducted in a hospital in Andra Pradesh State in India. The research was published in the International Journal of Basic and Clinical Pharmacology, the same Indian-based journal where the company has published studies done on some of its other products.
The company’s latest branded, multi ingredient offering, labeled as KaraLiv, is a proprietary blend of standardized herbal extracts of Momordica charantia (bitter melon), Phyllanthus niruri, Andrographis paniculata, Brassica rapa, Asparagus racemosus, and ginger. Karallief CEO Krishna Rajendran said each of these herbal extracts have been standardized to specific active compounds.
Rajendran grew up in the family’s herbal ingredient supply business in Bengaluru, India and then came to the United States to study for an MBA at Harvard University. Rajendran then subsequently opened a sister US company with its headquarters in Cambridge, MA.
Karallief supplies a number of branded, condition-specific herbal blends and a long list of single component herbal extracts and whole botanical ingredients.
Centrality of liver health
Rajendran said he believes liver health will become a more central concern for American consumers. With a new variant starting to dominate the global pandemic news, people will be ever more concerned with taking steps to guard their own health, he said.
“When we look at liver health it is so critical for so many different bodily functions,” Rajendran told NutraIngredients-USA.
“It is responsible for maintaining healthy homeostasis. Right now everyone wants a product focused on immunity. We think it makes sense to start by keeping you body healthy to start with,” he said.
Validating tradition through science
Like many of its other products, including a joint health blend released earlier this year, Rajendran said the approach with KaraLiv was to take clues from Ayurvedic tradition and then validate that with a modern scientific approach.
“All of these constituents have been used in India for centuries. We initially screened many different ingredients and came up with a short list we wanted to work with. We did more experiments to see what kind of synergy a blend could provide. That involved a lot of research, development and testing,” he said.
Rajendran said some real world experience also went into determining the blend’s final form. The company draws on the experience of a scientific board made of up medical doctors trained in Western methods as well as naturopathic physicians. Information gathered through these clinical practices was part of the development process, he said.
To test whether the finished product actually supports liver health, rather than relying on extrapolations from studies done on the individual components, the company commissioned a trial done last year at a hospital in the small eastern Indian city of Srikakulam.
The researchers recruited 60 subjects between 18 and 70 years of age who had been diagnosed with mild to moderate liver dysfunction as measured by liver enzyme levels. Subjects with sever liver malfunction, including alcohol-induced cirrhosis, were excluded.
Results clear statistical significance bar in all measures
The subjects were divided into experiment and placebo groups. They took the supplement or a placebo for 56 days. After the groups were set, each subject took the supplement or a place twice daily for the duration of the study. Blood and urine samples were collected and dietary questionnaires completed during three visits. The first was on day one, followed by a second visit at 28 days and another to wrap up the study.
The researchers found that KaraLiv provided statistically significant liver health benefits in all of the primary measures. For example, they found:
- 40% reduction in alanine aminotransferase (ALT) levels in the blood
- 53% reduction in aspartate aminotransferase (AST) levels in the blood
- 20% reduction in S alkaline phosphatase (ALP) levels in the blood
- 20% reduction in serum bilirubin levels
- 27% reduction in malondialdehyde (MDA) levels.
In addition, they found a 20% increase in superoxide dismutase (SOD) levels, which can be taken as a sign of a liver that is better equipped to deal with oxidative stress.
Upping the legitimacy ante
Rajendran said that while the company was expecting the study to succeed, the magnitude of the results was welcome.
“Most herbal products don’t really move the needle in a significant way except over a period of a few months. You can almost never compare them to a drug in the speed of action. But we were pleasantly surprised by these results. We found an effect almost twice as much as the placebo. It provides a clinically significant impact,” he said.
Rajendran said the approach with this ingredient is one the company will continue to follow to try to bring additional legitimacy to the industry.
“I would say less than .01% of the supplements in the market have direct clinical evidence behind them,” Rajendran said. “Ultimately, we want to make sure the consumer will benefit.”
Source: International Journal of Basic and Clinical Pharmacology
Assessment of safety and efficacy of a dietary supplement KaraLiv in supporting liver health: a double-blind, parallel, placebo-controlled randomized clinical trial
Authors: Rajendran K, Ramaswamy R, Venkateshwarlu K, Rajendran K, Naik KS