A Hypocaloric High-Protein Diet Supplemented with β-Cryptoxanthin Improves Non-Alcoholic fatty liver disease: A randomized controlled trial
Background: Despite promising animal data, there is no randomized controlled trial (RCT) on the effects of high protein (HP)-diet and/or β-cryptoxanthin in non-alcoholic fatty liver disease (NAFLD).
Aims: Safety and efficacy assessment of a hypocaloric HP-diet supplemented with β-cryptoxanthin in NAFLD.
Methods: Ninety-two Iranian NAFLD outpatients were recruited for this 12-week, single-center, parallel-group, double-blind RCT and randomized into 4 arms (n=23): HP-diet & β-cryptoxanthin (hypocaloric HP-diet + β-cryptoxanthin), HP-diet (hypocaloric HP-diet + placebo), β-cryptoxanthin (standard hypocaloric diet + β-cryptoxanthin), and control (standard hypocaloric diet + placebo). Serum levels of liver enzymes and grade of hepatic steatosis were assessed at baseline and study endpoint as outcome measures.
Results: In the intention-to-treat population (N=92), HP-diet & β-cryptoxanthin group experienced greater 12-week reductions in serum levels of liver enzymes than control group (mean difference for alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and gamma-glutamyl transferase: -27.2, -7.2, -39.2, and -16.3 IU/L, respectively; all p<0.010). Clinical remission rate (achieving grade 0 hepatic steatosis) in HP-diet & β-cryptoxanthin group (82.6%) was also higher than other groups (13.0%, 17.4%, and 0.0% in HP-diet, β-cryptoxanthin, and control groups, respectively; p<0.001). Sixteen patients reported minor adverse events.
Conclusion: A hypocaloric HP-diet supplemented with β-cryptoxanthin safely and efficaciously improves NAFLD.
Trial registration number: This trial was registered at http://www.irct.ir as IRCT2017060210181N10.
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A Hypocaloric High-Protein Diet Supplemented with β-Cryptoxanthin Improves Non-Alcoholic fatty liver disease: A randomized controlled trial
On 06 Oct, 2020
On 05 Oct, 2020
On 05 Oct, 2020
Posted 24 Sep, 2020
On 20 Oct, 2020
Received 25 Sep, 2020
On 25 Sep, 2020
On 23 Sep, 2020
On 23 Sep, 2020
On 23 Sep, 2020
Invitations sent on 22 Sep, 2020
On 22 Sep, 2020
On 22 Sep, 2020
Received 22 Sep, 2020
On 09 Sep, 2020
On 08 Sep, 2020
On 08 Sep, 2020
Background: Despite promising animal data, there is no randomized controlled trial (RCT) on the effects of high protein (HP)-diet and/or β-cryptoxanthin in non-alcoholic fatty liver disease (NAFLD).
Aims: Safety and efficacy assessment of a hypocaloric HP-diet supplemented with β-cryptoxanthin in NAFLD.
Methods: Ninety-two Iranian NAFLD outpatients were recruited for this 12-week, single-center, parallel-group, double-blind RCT and randomized into 4 arms (n=23): HP-diet & β-cryptoxanthin (hypocaloric HP-diet + β-cryptoxanthin), HP-diet (hypocaloric HP-diet + placebo), β-cryptoxanthin (standard hypocaloric diet + β-cryptoxanthin), and control (standard hypocaloric diet + placebo). Serum levels of liver enzymes and grade of hepatic steatosis were assessed at baseline and study endpoint as outcome measures.
Results: In the intention-to-treat population (N=92), HP-diet & β-cryptoxanthin group experienced greater 12-week reductions in serum levels of liver enzymes than control group (mean difference for alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and gamma-glutamyl transferase: -27.2, -7.2, -39.2, and -16.3 IU/L, respectively; all p<0.010). Clinical remission rate (achieving grade 0 hepatic steatosis) in HP-diet & β-cryptoxanthin group (82.6%) was also higher than other groups (13.0%, 17.4%, and 0.0% in HP-diet, β-cryptoxanthin, and control groups, respectively; p<0.001). Sixteen patients reported minor adverse events.
Conclusion: A hypocaloric HP-diet supplemented with β-cryptoxanthin safely and efficaciously improves NAFLD.
Trial registration number: This trial was registered at http://www.irct.ir as IRCT2017060210181N10.
Figure 1