Clinical Evidence for Hepaxa™ and Hepaxa™PD

The reduction of liver fat (in people with NAFLD) has a powerful effect on T2D, glycemic control and hypertension. 5

“Steatosis is now considered the initial step in a pathway that leads to advanced liver disease…” 2

A partial and temporary reduction in steatosis is associated with improved health outcomes (T2D) over a 10 year period. 4

Clinical Trail (RCT) on Hepaxa®.

A randomized placebo-controlled clinical trial using Hepaxa® was published in NUTRIENTS (Aug, 2018). The link to the online article is provided as: http://www.mdpi.com/2072-6643/10/8/1126/htm

– * Identification of patient most likely to respond – early-stage NAFLD patients with an FLI score>40 had a clear response to Hepaxa®. On average, the HFF of these patients dropped from 20% to 10%.

– * Confirmation of an effective threshold dose for EPA/DHA as Hepaxa® was effective in lowering steatosis in NAFLD patients.

Click here for a PDF Study highlights:

 

Meta Analysis on Omega-3 Supplementation for NAFLD.

A 2018 meta analysis summarized the results of various clinical studies over the past decade to confirm:

– The ideal NAFLD patient to be those with early-stage steatosis (rather than later stage NASH)

– The effective therapeutic daily dose threshold is 3gr omega-3 or 2.5gr of EPA/DHA

Click for copy of 2018 Meta Analysis on use of Omega-3 in NAFLD management

 

Multiple studies utilizing PUFA for dietary management of NAFLD

Click for white paper on Adult NAFLD Management

In an RCT, DHA supplementation decreases liver fat and visceral fat, and ameliorates metabolic abnormalities in children with NAFLD. A

In an RCT, DHA supplementation improves liver steatosis in children with NAFLD. B

In an RCT, DHA supplementation in children decreased the rate of steatosis, elevated ALT and elevated AST in the 12-month treatement in the PUFA group. C

Multiple studies utilizing PUFA for dietary management of Pediatric NAFLD

Click for white paper on Pediatric NAFLD Management

References:
1) V. Nobili, et. Al; Nutrition, Metabolism & Cardiovascular Diseases (2013) 23, 1066e1070
2) McPherson, S., et.Al, Journal of Hepatology 2015 vol. 62 j 1148–1155
3) L. Pacifico, et. Al; Nutrition, Metabolism & Cardiovascular Diseases (2015) 25, 734e741
4) Yamazaki, H., et.Al, Diabetes Care 2015;38:1673–1679
5) Peters et al, Journal of Nutritional Science, 2017, vol. 6, e15
6) Boyraz, M et. Al, J Clin res Endocrinol, 2015; 7(2): 121-27