Writing in the journal Nutrients, a team that included researchers from the University of Southampton found patients exhibited a 44% reduction in liver fat – a prime characteristic of the condition that can lead to liver malfunction.
“Studies have shown that NAFLD patients have lower levels of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) compared to healthy individuals,” said Dr Christoph Garbotz, BASF’s head of commercial management advanced health solutions, nutrition & health.
“As the newly published results of our clinical trial demonstrate, Hepaxa is able to correct this nutritional deficiency that NAFLD patients suffer from within 24 weeks of intervention.”
GRAS-approved formulation
Hepaxa, the firm’s highly concentrated EPA and DHA formulation used in the study, is designed to address a build-up of fat in the liver.
Launched in the US in February this year, the GRAS (Generally Recognized As Safe) approved product is set to become available in selected European markets in 2019.
High-concentration omega-3 formulations, whether in capsule or powder form, have proved popular amongst consumers, eager to gain maximum benefits from the fish oils while avoiding the relatively arduous dosage regimen.
Additionally, there are some in the sector that claim the higher the concentration, the more difficulty there is in digestion, although there is little data currently to back that assertion.
Earlier this month, Evonik received the go-ahead from European authorities to market its high-concentration omega-3 lysine powder complex AvailOm in the European Union.
The German-based firm’s approval follows algal fermentation specialist Fermentalg’s deal with global ingredients supplier DSM Nutritional Products to develop and market high potency DHA ingredients.
The French microalgae firm said the five-year contract would accelerate penetration of its Origins DHA-550 product line.
Under terms of the agreement, Fermentalg has granted exclusive rights to DSM for selling its high-potency DHA products in certain market segments.
“Hepaxa contains highly concentrated and highly pure omega-3 fatty acids with a specific EPA/DHA-ratio,” said Dr Garbotz.
“Hepaxa is marketed and sold as a medical food in the US and are intended for the dietary management of patients suffering from NAFLD.
“In contrast to dietary supplements, Hepaxa has been shown to be effective in the dietary management and is safe in this population.”
Study details
The study, covering 176 patients with NAFLD, were randomised to receive the omega-3 concentrate (sample size - 87) or placebo (sample size - 89) for 24 weeks.
The omega-3 index, omega-6: omega-3 fatty acid ratio and quantitative measurements of red blood cell (RBC) count, EPA and DHA were determined at the start and end of the study.
The research team found administration of high concentrate omega-3 for 24 weeks significantly increased the omega-3 index and absolute values of RBC, EPA and DHA.
Additional findings revealed a decreased RBC omega-6: omega-3 fatty acid ratio as well as a significant reduction in liver fat content in both groups.
“The current randomized placebo-controlled study supports the use of omega-3 supplementation to increase the omega-3 index in NAFLD patients, significantly greater than that obtained by dietary recommendation alone,” the study concluded.
“The liver fat content of patients was significantly reduced amongst both placebo and intervention arms, thereby masking any effects omega-3 may have had on the fat content of the liver.”
Source: Nutrients
Published online: doi.org/10.3390/nu10081126
“Evaluation of a High Concentrate Omega-3 for Correcting the Omega-3 Fatty Acid Nutritional Deficiency in Non-Alcoholic Fatty Liver Disease (CONDIN).”
Authors: Derek Tobin, Merethe Brevik-Andersen, Yan Qin, Jacqueline Innes and Philip Calder.
