Synbiotic supplementation in nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled pilot study123

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ABSTRACT

Background:

Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in the world. Oral administration of synbiotic has been proposed as an effective treatment of NAFLD because of its modulating effect on the gut flora, which can influence the gut-liver axis.

Objective:

The objective was to evaluate the effects of supplementation with synbiotic on hepatic fibrosis, liver enzymes, and inflammatory markers in patients with NAFLD.

Design:

In a randomized, double-blind, placebo-controlled clinical trial conducted as a pilot study, 52 patients with NAFLD were supplemented twice daily for 28 wk with either a synbiotic or a placebo capsule. Both groups were advised to follow an energy-balanced diet and physical activity recommendations.

Results:

At the end of the study, the alanine aminotransferase (ALT) concentration decreased in both groups; this reduction was significantly greater in the synbiotic group. At the end of the study, the following significant differences [means (95% CIs)] were seen between the synbiotic and placebo groups, respectively: ALT [−25.1 (−26.2, −24) compared with −7.29 (−9.5, −5.1) IU/L; P < 0.001], aspartate aminotransferase [−31.33 (−32.1, −30.5) compared with −7.94 (−11.1, −4.8) IU/L; P < 0.001], γ-glutamyltransferase [−15.08 (−15.5, −14.7) compared with −5.21 (−6.6, −3.9) IU/L; P < 0.001], high-sensitivity C-reactive protein [−2.3 (−3, −1.5) compared with −1.04 (−1.5, −0.6) mmol/L; P < 0.05], tumor necrosis factor-α [−1.4 (−1.7, −1.1) compared with −0.59 (−0.8, −0.3) mmol/L; P < 0.001], total nuclear factor κ-B p65 [−0.016 (−0.022, −0.011) compared with 0.001 (−0.004, −0.007) mmol/L; P < 0.001], and fibrosis score as determined by transient elastography [− 2.98 (−3.6, −2.37) compared with −0.77 (−1.32, −0.22) kPa; P < 0.001].

Conclusions:

Synbiotic supplementation in addition to lifestyle modification is superior to lifestyle modification alone for the treatment of NAFLD, at least partially through attenuation of inflammatory markers in the body. Whether these effects will be sustained with longer treatment durations remains to be determined. This trial was registered at http://www.clinicaltrials.gov as NCT01791959.

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1

From the Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology, Research Institute Shahid Beheshti University of Medical Science, Tehran, Iran (TE and AH); the Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran (TE, HP, MS, and RM); and the Gastroenterology and Liver Disease Research Center, Firoozgar Hospital, Tehran University of Medical Sciences, Tehran, Iran (FZ).

2

Supported by the National Nutrition and Food Technology Research Institute of the Shahid Beheshti University and the Digestive Disease Research Institute of the Shariati Hospital. Protexin Company, UK, provided the synbiotic supplements, and Nikan Teb Co provided the FibroScan machine.

3

Address correspondence to A Hekmatdoost, Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute Shahid Beheshti University of Medical Science, 7 No, West Arghavan Street, Farahzadi Boulevard, PO Box 19395-4741, Tehran, Iran 1981619573. E-mail: [email protected]; and H Poustchi, Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Shariati Hospital, PO Box 14117-13135, Tehran, IR Iran. E-mail: [email protected].

4

Abbreviations used: ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; FBS, fasting blood sugar; GGT, γ-glutamyltransferase; MET, metabolic equivalent of task; NAFLD, nonalcoholic fatty liver disease; NASH, nonalcoholic steatohepatitis; NF-κB, nuclear factor κ-B; PBMC, peripheral blood mononuclear cell; WHR, waist-to-hip ratio.