Z Gastroenterol 2017; 55(05): e28-e56
DOI: 10.1055/s-0037-1603435
Hepatologie
Georg Thieme Verlag KG Stuttgart · New York

A prospective study to evaluate the efficacy of a standardized low calorie diet (HEPAFAST®) according to PNPLA3 genotype in patients with Non Alcoholic Fatty Liver Disease (NAFLD) – 2 months data (interim analysis)

M Teufelhart
1   Sanatorium Hera, Health and Prevention Center, Vienna, Austria
,
H Hofer
2   Clinikum Wels-Grießkirchen, Dep. of Internal Medicine I, Wels, Austria
,
H Haslacher
3   Medical University of Vienna, Dep. of Laboratory Medicine, Vienna, Austria
,
R Winker
1   Sanatorium Hera, Health and Prevention Center, Vienna, Austria
,
B Meyer
1   Sanatorium Hera, Health and Prevention Center, Vienna, Austria
,
P Ferenci
4   Medical University of Vienna, Dep. of Internal Medicine III, Division of Gastroenterology and Hepatology, Vienna, Austria
,
B Mehl
1   Sanatorium Hera, Health and Prevention Center, Vienna, Austria
,
C Rabitsch
1   Sanatorium Hera, Health and Prevention Center, Vienna, Austria
,
S Nistler
1   Sanatorium Hera, Health and Prevention Center, Vienna, Austria
,
M Trauner
4   Medical University of Vienna, Dep. of Internal Medicine III, Division of Gastroenterology and Hepatology, Vienna, Austria
,
T Scherzer
1   Sanatorium Hera, Health and Prevention Center, Vienna, Austria
› Author Affiliations
Further Information

Publication History

Publication Date:
16 May 2017 (online)

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Background. Steatosis can lead to NASH, liver cirrhosis, HCC as well as aggravation of diabetes and cardiovascular diseases. PNPLA3 is associated with NAFLD. The HEPAFAST® protein shake is developed to treat NAFLD and is enriched with liver protective substances, such as ß-glucan and cholin. Aim of the study is to analyze the efficacy of a standardized low calorie diet (HEPAFAST®, Bodymed, Germany) and the influence of PNPLA3 genotypes on treatment outcome.

Methods. Overall 81 non cirrhotic patients are stratified according to PNPLA3 genotypes (27 patients per group; CC, CG, GG). All patients receive HEPAFAST® shakes for 2 weeks (1000 kcal/day) followed by a low glycemic and insulinemic (LOGI) diet for another 6 weeks (EOT). At each study visit (baseline, week 2, 2 months and 6 months-follow up) liver fat content is assessed with Fibroscan® CAP. Additionally Fatty Liver Index (FLI), waist circumference (WC), BMI and Vitamin D are measured.

Results. To date 44 patients [age 45.7 ± 9.0 (mean ± SD); m: 28, f: 16; PNPLA3 genotypes: CC: 20, CG: 17, GG: 6] finished HEPAFAST® therapy from baseline (bl) to week 2 (wk2), 36 patients completed LOGI diet for another 6 weeks. All outcome variables significantly decreased from bl to wk2 and further till EOT: (1) Fibroscan CAP 318.0 ± 29.1dB/m2 to 270.3 ± 34.1 (p < 0.001) and 245.0 ± 31.7 (p < 0.001), (2) FLI 77.5 ± 16.9 to 57.2 ± 21.2 (p < 0.001) and 56.1 ± 21.9 (p < 0.001), (3) WC 108.2 ± 8.8 cm to 104.7 ± 8.7 (p < 0.001) and 101.4 ± 8.4 (p < 0.001), (4) BMI 31.8 ± 3.6 to 30.3 ± 3.4 (p < 0.001) and 29.3 ± 3.4 (p < 0.001), (5) Vitamin D 22.8 ± 8.6 ng/ml to 25.3 ± 8.8 (p < 0.001) and 28.1 ± 9.2 (p < 0.001). 29 patients finished 6 months follow up, CAP remained low at 253.3 ± 38.2 (p < 0.001). Currently CAP values according to PNPLA3 genotype show no significant difference on a standardized HEPAFAST® therapy [CC: 310.8 ± 29.3 to 268.7 ± 40.1 (Δ42.1 ± 34.5) vs. G-allele: 324.0 ± 28.1 to 271.7 ± 29.0 (Δ52.3 ± 30.5); p = 0.43] and EOT [CC: 312.2 ± 29.3 to 238.2 ± 33.1 (Δ74.0 ± 30.1) vs. G-allele: 329.9 ± 28.2 to 252.6 ± 29.0 (Δ77.3 ± 27.6); p = 0.91].

Conclusion. HEPAFAST® diet is an effective strategy to significantly lower liver fat in NAFLD patients. CAP and Vitamin D further improve on LOGI diet.