Introducing Hepaxa™PD

The first product designed to support
children aged 10-18 with NAFLD.

The reduction of liver fat (in people with NAFLD) has a powerful effect on Type-2 Diabetes (T2D), glycemic control and hypertension. 5

Pediatric NAFLD can be reversed.

If NAFLD is addressed early, with adjustment to diet and exercise, many children can naturally reverse their liver fat composition to less than 5%. Doing so can restore their natural liver function and help to improve their overall and long-term health.

However, many children with NAFLD patients have been unsuccessful in making lifestyle changes to the extent needed for better health.  In these cases, doctors want to provide extra help.  Clinical studies have shown that daily use of poly unsaturated fatty acids (PUFA) like Hepaxa™PD can reduce liver fat and in time reverse steatosis in NAFLD. Hepaxa™PD is designed to help the dietary management of steatosis in children with early stage NAFLD.

“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

How to dose Hepaxa™PD for children.

Hepaxa™PD is indicated for children from age 10 to 18. However, the number of capsules to be used daily can vary. This dose calibration is usually a function of size. Adults take four Hepaxa™ capsules daily. That is too much for most children. Instead, one capsule daily is used for pediatric NAFLD patients who are considered “overweight” on a BMI chart. That area is shaded as yellow in the chart below. Two capsules daily is used for pediatric NAFLD patients who are considered “obese” on the chart below. This range is shaded as orange.

NOTE: Body Mass Index (BMI) is a simplified calculation which combines the child’s height and weight.

The BMI chart is merely a guide. Please note that patients shaded in the red zones will be dosed at the discretion of their pediatrician. 

Clinical Evidence for management of Pediatric NAFLD with (PUFA) Hepaxa™PD

Clinical Support (6-24 months)

In a double-blind, placebo controlled trial, DHA supplementation decreases liver and visceral fat, and ameliorates metabolic abnormalities in children with NAFLD.3

In a randomized controlled trial, DHA supplementation improves liver steatosis in children with NAFLD.1

  • Triglycerides were lower in the DHA groups (250mg and 500mg) than in the placebo group at any time point and ALT was lower in these groups from month 12 onwards (p < 0.05).
  • “In this RCT, we found that a previously reported decrease in liver fat obtained at 6 months persisted virtually unchanged after 24 months of supplementation with DHA.”

All children were considered to have had degree 2 or 3 liver steatosis at baseline and a balanced low- calorie diet was prescribed and physical activity was suggested to all patients (average age 13 for placebo and 11 for DHA group)

Clinical Support (12 months)

In a double-blind, placebo controlled trial, DHA supplementation in children decreased the frequency of steatosis, elevated alanine aminotransferase (ALT) and elevated aspartate aminotransferase (AST) in the 12-month treatment in the polyunsaturated fatty acids (PUFA) group.6

After 12 months of diet plus PUFA therapy and lifestyle intervention

  • 67.8% of patients ultrasonography showed a reduction in fatty liver disease (p<0.001) compared to 40.3% of patients in the placebo group
  • Significantly higher HDL-C (45.4±6.9 vs. 38±8.6 mg/dL, p=0.02) than placebo
  • Significantly lower triglyceride levels (53.3±22.3 vs. 65.8±23.3 mg/dL, p=0.01) than placebo
  • Fasting insulin concentrations declined from 13.4±8.7 IU/L to 7.4±4.9 IU/L (p=0.008), with no change in the placebo group (11.5±9.9 to 9±4.4 IU/L, p>0.05)
  • Fasting glucose values were significantly lower (86±18.4 vs. 72.4±8.9 mg/dL, p=0.001) compared to placebo
  • HOMA-IR significantly decreased (2.98±1.45 vs. 1.9±1.2, p=0.006)
  • BMI significantly decreased from 29.7±4.8 to 23.7±3.5 (p=0.01)

NAFLD in the United States

Fatty Liver disease has become an epidemic.  The correct term is non-alcoholic fatty liver disease of NAFLD and the growth rate for the number of people being diagnosed has doubled in the past generation. For Children aged 10-18, the growth rate for NAFLD has tripled over that same time period.  Moreover, the progression from early stage NAFLD to more severe liver disease is reported to be accelerated in children. More children are candidates for liver failure than ever before.

What is NAFLD?

As your doctor may have informed you, the liver is designed to process fat. With NAFLD, the liver begins to store fat.  This decreases the ability for the liver to properly function. When a person has more than 5% liver fat composition, they are diagnosed as NAFLD.  This process of storing excess liver fat is also called steatosis. Over time, steatosis can lead to more serious forms of the disease including Non-Alcoholic Steatohepatitis (NASH) and Cirrhosis. NAFLD can also increase your risk of cardiovascular events and complications will increase as NAFLD increases.

References:
1) V. Nobili, et. Al; Nutrition, Metabolism & Cardiovascular Diseases (2013) 23, 1066e1070, 6 (Yamazaki, 2015, Diabetes care; Fukuda,
2016, Eur J Gastroenterol Hepatol)
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
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