Background & Aims No treatment for nonalcoholic fatty liver disease (NAFLD) has been approved by regulatory agencies. We performed a randomized controlled trial to determine whether 52 weeks of cysteamine bitartrate delayed release (CBDR) reduces the severity of liver disease in children with NAFLD. Methods We performed a double-masked trial of 169 children with NAFLD Activity Scores ≥ 4 at 10 centers. From June 2012 to January 2014, the patients were randomly assigned to receive CBDR or placebo twice daily (300 mg for ≤65 kg, 375 mg for >65–80 kg, 450 mg for >80 kg) for 52 weeks. The primary outcome from the intention to treat analysis was improvement in liver histology over 52 weeks, defined as a decrease in NAFLD Activity Score ≥ 2 points without worsening fibrosis; patients without biopsies from week 52 (17 in the CBDR group and 6 in the placebo group) were considered non-responders. We calculated relative risks (RR) of improvement using stratified Cochran-Mantel-Haenszel analysis. Results There was no significant difference between groups in the primary outcome (28% of children in the CBDR group vs 22% in the placebo group; RR, 1.3; 95% CI, 0.8–2.1; P=.34). However, children receiving CBDR had significant changes in pre-specified secondary outcomes: reduced mean levels of alanine aminotransferase (reduction of 53±88 U/L vs a reduction of 8±77 U/L in the placebo group; P=.02) and aspartate aminotransferase (reduction of 31±52 vs a reduction of 4±36 U/L in the placebo group; P=.008), and a larger proportion had reduced lobular inflammation (in 36% of patients in the CBDR group vs placebo 21% of patients in the placebo group; RR, 1.8; 95% CI, 1.1–2.9; P=.03). In a post-hoc analyses, of children ≤65 kg, those taking CBDR had a 4-fold better chance of histologic improvement (observed in 50% of children in the CBDR group vs 13% in the placebo group; RR, 4.0; 95% CI, 1.3–12.3; P=.005). Conclusions In a randomized trial, we found that 1 year of CBDR did not reduce overall histologic markers of NAFLD compared with placebo in children. Children receiving CBDR did, however, have significant reductions in serum levels of aminotransferase levels and lobular inflammation. ClinicalTrials.gov no: NCT01529268.

The purpose of the current study was to examine the effects of a very low-carbohydrate diet on weight loss and biochemical parameters in overweight women. Twenty women completed an 8-week trial that reduced their daily carbohydrate intake from 232 to 71 g (p < 0.05) and reduced energy by 2,644 kJ/day (8,384 to 5,740 kJ, p < 0.001). The average weight loss was 5.0 kg (p < 0.0001), with a net decrease in body mass index of 1.82 kg/m2, a loss of 3.4% body fat (4 kg, p < 0.0001), and a loss of 1.0 kg lean mass (p < 0.05). There were no significant changes in fasting blood glucose, fasting serum insulin, oral glucose tolerance, free or total insulin-like growth factor-1, or total IGFBP-3. Systolicblood pressure decreased by an average of 9.0 mmHg (1 mmHg = 133.322 Pa) (p < 0.01) and diastolic blood pressure decreased by 7 mmHg (p < 0.05). Total cholesterol decreased 1.2 mM (p < 0.001), all of which was accounted for by a decrease in low-density lipoprotein cholesterol (p < 0.001) with no change in high-density lipoprotein cholesterol (baseline, 1.17 mM; week 8, 1.22 mM). Total triacylglycerol decreased 0.6 mM (p < 0.01), and the ratio of triacylglycerol/HDL also significantly decreased (baseline, 1.40; week 8, 0.87; p < 0.001). Serum beta-hydroxybutyrate concentrations rose significantly by week 2 and declined thereafter but remained significantly higher than baseline values for the duration of the intervention. Therefore, carbohydrate restriction to 70 g or less with concomitant energy restriction, without changes in protein or fat consumption, promotes weight loss, and improvements in body composition, blood pressure, and blood lipids without compromising glucose tolerance in moderately overweight women.

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