Liver Health Supplement Opportunities | INITIATED Natural Products

Non-alcoholic fatty liver disease (NAFLD) is a growing medical problem. According to the American Liver Foundation, the consumption of processed foods and drugs, as well as the occurrence of diabetes and obesity are on the rise. Liver health is set to become a major concern of the modern era, providing opportunities for nutraceutical development.

Most products on the market are still herbal products with little or no clinical data or bioavailability. This is problematic because most solutions for liver problems use milk thistle extract: its main active component, silybin, has low bioavailability. Some manufacturers are content with a mixture of different herbs known for their traditional use against liver problems, ignoring which parts of the plant should be used and the possible cross-interactions between the substances.

The solutions are generally positioned as “liver detox”, however, no randomized controlled trials have been conducted to evaluate the effectiveness of commercial detox diets in humans.1

Liver health is one of the categories where the gap between demand and the availability of innovative solutions is surprising. Despite growing consumer attention, the market lacks high-quality nutraceutical solutions. It is important to note that almost no solution is aimed directly at children. This could be due to the lesser known fact that NAFLD affects children as frequently as adults.

NAFLD is a common disorder referring to a group of conditions in which abnormal hepatic fatty acid metabolism results in the accumulation of excess fat in the liver, without significant alcohol consumption, viral infection, or any other specific etiology likely to cause cause liver disease.

Its development begins with lipid deposition and progresses to involve oxidative stress, inflammation and fibrosis. Non-alcoholic steatohepatitis (NASH) is a more severe form of NAFLD, in which fat accumulation is accompanied by inflammation, fibrosis, scarring of the liver and subsequent loss of function. If left untreated, it can lead to irreversible cirrhosis and eventually liver failure, or progress to hepatocellular carcinoma, the most common type of liver cancer.

Between 30-40% of adults in the United States have NAFLD, and 3-12% of adults in the United States have NASH.2 Researchers estimate that nearly 10% of American children ages 2-19 have NAFLD.3

NAFLD patients rarely show symptoms. No drugs have been approved to treat NAFLD and NASH; patients are generally advised to follow a strict diet, lose weight, and be prescribed diabetes medications or statins, intended to treat related effects on insulin metabolism or the cardiovascular system.

Early identification is crucial to preventing the progression of NAFLD and can improve patient outcomes through therapeutic intervention. Given its benefits in countering the early onset of NAFLD, supplementation with liver-protecting ingredients may see significant growth in the coming years.

Product formulation

Several scientific publications have demonstrated some benefit of supplementation for the prevention of liver disease. The most effective nutrients considered were vitamins D and E in high concentrations, omega-3 fatty acids, choline, S-adenosyl-L-methionine (SAMe), and polyphenols from various plant extracts.4 All present positive effects on the protection of the liver thanks to inflammatory and antioxidant properties. For now, choline is the only nutrient for which the European Food Safety Authority (EFSA) has authorized a health claim related to liver health: “choline contributes to the maintenance of normal liver function” . Consumers being more and more educated, it is necessary to formulate a product with scientifically proven ingredients, with bioavailability studies, to guarantee a quality solution, reinforcing the trust and credibility of the brand.

Product development

A carefully selected mix of ingredients, however, is not enough to guarantee quality. Nutraceutical manufacturers should test the stability of their finished product. The more ingredients incorporated, the greater the risk that the product will not be stable over the entire shelf life. This is especially true when developing solutions in user-friendly forms. Stability in liquid form requires significant expertise, but even more so for liver health supplements, which typically include several complex herbal extracts.

Liver health is a growing indication for which quality solutions are sorely lacking. A product that verifies all market requirements is inevitably difficult to develop, as clinical justification, bioavailability and stability testing all require large investments. However, it is important to note that such a solution would be greatly rewarded by consumers, as all the factors causing NAFLD are only expected to grow in the future.

Maja Orešnik is Scientific and Research Director at PharmaLinea Ltd.

The references

1. Klein A, Kiat H. “Detox Diets for Toxin Removal and Weight Management: A Critical Review of the Evidence.” Diet J Hum Nutr. 2015 Dec;28(6):675-86. DOI: 10.1111/jhn.12286.

2. Spengler E, Loomba R. “Recommendations for the diagnosis, referral for liver biopsy, and treatment of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis.” Mayo ClinProc. 2015 Sep;90(9):1233-46. DOI: 10.1016/j.mayocp.2015.06.013.

3. Schwimmer J et al. “Prevalence of fatty liver disease in children and adolescents.” Pediatrics. 2006 Oct;118(4):1388-93.

4. Barchetta I, Cimini F, Cavallo M. “Vitamin D supplementation and nonalcoholic fatty liver disease: present and future.” Nutrients. 2017 Sep 14;9(9). pii: E1015. DOI: 10.3390/nu9091015.

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