Dataset Information

Effects of fructose restriction on liver steatosis (FRUITLESS); a double-blind randomized controlled trial.

ABSTRACT:

Background

There is an ongoing debate on whether fructose plays a role in the development of nonalcoholic fatty liver disease.

Objectives

The aim of this study was to investigate the effects of fructose restriction on intrahepatic lipid (IHL) content in a double-blind randomized controlled trial using an isocaloric comparator.

Methods

Between March 2017 and October 2019, 44 adult overweight individuals with a fatty liver index ? 60 consumed a 6-wk fructose-restricted diet (<7.5 g/meal and <10 g/d) and were randomly assigned to supplementation with sachets of glucose (= intervention group) or fructose (= control group) 3 times daily. Participants and assessors were blinded to the allocation. IHL content, assessed by proton magnetic resonance spectroscopy, was the primary outcome and glucose tolerance and serum lipids were the secondary outcomes. All measurements were conducted in Maastricht University Medical Center.

Results

Thirty-seven participants completed the study protocol. After 6 wk of fructose restriction, dietary fructose intake and urinary fructose excretion were significantly lower in the intervention group (difference: -57.0 g/d; 95% CI: -77.9, -39.5 g/d; and -38.8 ?mol/d; 95% CI: -91.2, -10.7 ?mol/d, respectively). Although IHL content decreased in both the intervention and control groups (P < 0.001 and P = 0.003, respectively), the change in IHL content was more pronounced in the intervention group (difference: -0.7% point, 95% CI: -2.0, -0.03% point). The changes in glucose tolerance and serum lipids were not significantly different between groups.

Conclusions

Six weeks of fructose restriction per se led to a small, but statistically significant, decrease in IHL content in comparison with an isocaloric control group.This trial was registered at clinicaltrials.gov as NCT03067428.

SUBMITTER: Simons N

PROVIDER: S-EPMC7851818 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

Effects of fructose restriction on liver steatosis (FRUITLESS); a double-blind randomized controlled trial.

Simons Nynke N Veeraiah Pandichelvam P Simons Pomme I H G PIHG Schaper Nicolaas C NC Kooi M Eline ME Schrauwen-Hinderling Vera B VB Feskens Edith J M EJM van der Ploeg E M C Liesbeth EMCL Van den Eynde Mathias D G MDG Schalkwijk Casper G CG Stehouwer Coen D A CDA Brouwers Martijn C G J MCGJ

The American journal of clinical nutrition 20210201 2

<h4>Background</h4>There is an ongoing debate on whether fructose plays a role in the development of nonalcoholic fatty liver disease.<h4>Objectives</h4>The aim of this study was to investigate the effects of fructose restriction on intrahepatic lipid (IHL) content in a double-blind randomized controlled trial using an isocaloric comparator.<h4>Methods</h4>Between March 2017 and October 2019, 44 adult overweight individuals with a fatty liver index ≥ 60 consumed a 6-wk fructose-restricted diet ( ...[more]

PMID: 33381794

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Project description:IntroductionTo evaluate the efficacy of empagliflozin compared to pioglitazone in patients with non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes (T2DM).MethodsIn this prospective randomized, double-blind, placebo-controlled trial, we assigned 106 patients with NAFLD and T2DM to receive empagliflozin 10 mg (n = 35), pioglitazone 30 mg (n = 34), or placebo (n = 37) for 24 weeks. Liver fat content and liver stiffness were measured using fibroscans. Body composition assessment was performed by dual-energy x-ray absorptiometry (DEXA) scans. The primary end point was change from baseline in liver steatosis, using the controlled attenuation parameter (CAP) score.ResultsA borderline significant decrease in CAP score was observed with empagliflozin compared to placebo, mean difference: - 29.6 dB/m (- 39.5 to - 19.6) versus - 16.4 dB/m (- 25.0 to - 7.8), respectively; p = 0.05. Using multivariate analysis, we observed a significant reduction in the placebo-corrected change in liver stiffness measurement (LSM) with empagliflozin compared to pioglitazone: - 0.77 kPa (- 1.45, - 0.09), p = 0.02, versus 0.01 kPa (95% CI - 0.70, 0.71, p = 0.98), p for comparison = 0.03. Changes in serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT), fasting insulin, homeostatic model assessment for insulin resistance (HOMA-IR), HOMA2-IR, fibrosis-4 index (FIB4 index), NAFLD fibrosis score, aspartate aminotransferase to platelet ratio index (APRI), android/gynecoid ratio (A/G ratio), and skeletal muscle index (SMI) were comparable between the two treatment groups, while significant reductions of the body weight and visceral fat area were observed only in the empagliflozin group (p < 0.001 and p = 0.01, respectively) and both were increased in the placebo and pioglitazone groups. There were no serious adverse events in either group.ConclusionTreatment for 24 weeks with empagliflozin, in contrast to pioglitazone, was associated with improvement of liver steatosis and fibrosis in patients with NAFLD and T2DM. In addition, body weight and abdominal fat area were decreased in the empagliflozin group.Trial registrationIranian Registry of Clinical Trials (IRCT), IRCT20190122042450N3.

Dataset Information

Effects of fructose restriction on liver steatosis (FRUITLESS); a double-blind randomized controlled trial.

Background

Objectives

Methods

Results

Conclusions

Publications

Effects of fructose restriction on liver steatosis (FRUITLESS); a double-blind randomized controlled trial.

Similar Datasets

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