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 Trial (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.
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
Multiple studies utilizing PUFA for dietary management of NAFLD
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
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