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Research article
Abdollah Hojhabrimanesh
Ahvaz Jondishapour University of Medical Sciences
Corresponding Author
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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.
Keywords
Non-alcoholic fatty liver disease, β-cryptoxanthin, High protein diet
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CURRENT STATUS: Published
View the published article at BMC Gastroenterology.
Version 1
Posted 24 Sep, 2020
No community comments so far
Review #2 received
Received 25 Sep, 2020
Editorial decision: Minor revision
On 25 Sep, 2020
Reviewer #3 agreed
On 23 Sep, 2020
Reviewer #4 agreed
On 23 Sep, 2020
Reviewer #5 agreed
On 23 Sep, 2020
Reviewers invited
Invitations sent on 22 Sep, 2020
Reviewer #1 agreed
On 22 Sep, 2020
Reviewer #2 agreed
On 22 Sep, 2020
Review #1 received
Received 22 Sep, 2020
Editor assigned
On 09 Sep, 2020
Submission checks complete
On 08 Sep, 2020
Editor invited
On 08 Sep, 2020
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Subject Areas
Gastroenterology & Hepatology
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See the published version of this preprint at BMC Gastroenterology.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Abdollah Hojhabrimanesh
Ahvaz Jondishapour University of Medical Sciences
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at BMC Gastroenterology.
Version 1
Posted 24 Sep, 2020
No community comments so far
Review #2 received
Received 25 Sep, 2020
Editorial decision: Minor revision
On 25 Sep, 2020
Reviewer #3 agreed
On 23 Sep, 2020
Reviewer #4 agreed
On 23 Sep, 2020
Reviewer #5 agreed
On 23 Sep, 2020
Reviewers invited
Invitations sent on 22 Sep, 2020
Reviewer #1 agreed
On 22 Sep, 2020
Reviewer #2 agreed
On 22 Sep, 2020
Review #1 received
Received 22 Sep, 2020
Editor assigned
On 09 Sep, 2020
Submission checks complete
On 08 Sep, 2020
Editor invited
On 08 Sep, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Gastroenterology & Hepatology
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at BMC Gastroenterology.
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
This is a list of supplementary files associated with this preprint. Click to download.
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