Karallief finds statistically significant benefits for liver health blend
The research, which was funded by Karallief, was conducted at a hospital in Andra Pradesh state in India. The research was published in the International Journal of Basic and Clinical Pharmacology, The same India-based journal where the company has published studies done on some of its other products.
The company’s latest branded multi-ingredient offering, labeled KaraLiv, is a proprietary blend of standardized plant extracts from Momordica charantia (bitter melon), Phyllanthus niruri, Andrographis paniculata, Brassica rapa, Asparagus racemosusand ginger. Karallief CEO Krishna Rajendran said each of these plant extracts has been standardized into specific active compounds.
Rajendran grew up in the family business of supplying herbal ingredients in Bengaluru, India, then came to the United States to study for an MBA at Harvard University. Rajendran then opened an American sister company with its headquarters in Cambridge, MA.
Karallief supplies a number of branded and 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 global pandemic news, people will be increasingly concerned about taking action to protect their own health, he said.
“When we look at the health of the liver, 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 your body healthy to begin with ”,he said.
Validating tradition through science
Like many of its other products, including a common health mix released earlier this year, Rajendran said the approach with KaraLiv was to take clues from the Ayurvedic tradition and then validate them with a modern scientific approach.
“All of these constituents have been used in India for centuries. We first sifted through many different ingredients and came up with a short list that we wanted to work with. We did more experiments to see what kind of synergy a blend could provide. It involved a lot of research, development and testing ”,he said.
Rajendran said that some real-world experience also helped determine the final shape of the mixture. The company relies on the experience of a scientific council made up of doctors trained in Western methods as well as naturopaths. The 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 conducted last year at a small-scale hospital. town of Srikakulam in eastern India.
The researchers recruited 60 subjects aged 18 to 70 who had been diagnosed with mild to moderate liver dysfunction, as measured by levels of liver enzymes. Subjects with severe hepatic dysfunction, including alcohol-induced cirrhosis, were excluded.
Results clear the statistical significance bar in all measures
The subjects were divided into experimental and placebo groups. They took the supplement or a placebo for 56 days. Once the groups were defined, each subject took the supplement or a place twice daily for the duration of the study. Blood and urine samples were collected and food questionnaires completed during three visits. The first took place on the first day, followed by a second visit at 28 days and another to conclude the study.
The researchers found that KaraLiv offered statistically significant benefits for liver health in all major 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 alkaline phosphatase S (ALP) levels in the blood
- 20% reduction in serum bilirubin levels
- 27% reduction in malondialdehyde (MDA) levels.
Additionally, they found a 20% increase in superoxide dismutase (SOD) levels, which can be taken as a sign of a liver better equipped to cope with oxidative stress.
Raise the bar of legitimacy
Rajendran said that while the company expected the study to be successful, the scale of the results was welcome.
“Most herbal products don’t really move the needle significantly except over a period of a few months. You can hardly ever compare them to a drug in terms of speed of action. But we were pleasantly surprised by these results. We found an effect almost twice as strong as the placebo. This has a clinically significant impact ”,he said.
Rajendran said the approach with this ingredient is one the company will continue to take in trying to bring additional legitimacy to the industry.
“I would say less than 0.01% of the supplements on the market have direct clinical evidence behind them,”Rajendran said. “At the end of the day, we want to make sure that the consumer will benefit. “
Source: International Journal of Basic and Clinical Pharmacology
Evaluating the Safety and Effectiveness of a KaraLiv Dietary Supplement for Supporting Liver Health: A Double-Blind, Parallel, Placebo-Controlled Randomized Clinical Trial
Authors: Rajendran K, Ramaswamy R, Venkateshwarlu K, Rajendran K, Naik KS