Reviewer’s report
Title:  Curcumin and Inflammation in Non-alcoholic Fatty Liver Disease: a Randomized, Placebo
Controlled Clinical Trial
Version: 0 Date: 06 Jun 2019
Reviewer: Fernando Bril
Reviewer's report:
In  this  proof-of-concept  study,  Saadati  et  al  assessed  the  role  of curcumin  to  reduce  subclinical
inflammation in patients with NAFLD. The authors should be congratulated for a well-designed study.
However, the presentation and interpretation of their results must be revised before this manuscript is
ready for publication.
-Briefly, this is a negative study, where all comparisons between curcumin vs. placebo were
negative. Therefore, the study should be presented as such. Within group comparisons (i.e.,
before vs. after) have only minimal importance in this scenario, and conclusions should not be
driven by these.
-Please  re-write  the  manuscript  (results  and  discussion)  based  on  the  main  comparison  of
curcumin vs. placebo. Avoid statements claiming a significant action of curcumin based on
within group comparisons.
-Sample size calculation: please provide more details. What do the authors mean by 2 units? 2
pg/ml? What was the expected SD? Is this clinically relevant? Please justify.
-In  addition  to  IRB  approval,  was  this  clinical  trial  included  in  any  RCT  registry  (e.g.,
www.clinicaltrials.gov, etc.)? Please mention this under Methods.
-Table 1: % of smokers should be reported per column, not % per row.
-"3 capsules containing either 500mg curcumin or matched placebo per day after each meal for
12 weeks" is unclear. Please clarify dose. 500mg TID or 1500mg QD or 1500mg TID?
-There are several grammatical mistakes throughout the manuscript. I would suggest having it
revised by a native English speaker.
-No information is provided regarding physical activity and caloric intake between the groups
during the 12 weeks of the trial.
Are the methods appropriate and well described?
If not, please specify what is required in your comments to the authors.
Yes
Does the work include the necessary controls?
If not, please specify which controls are required in your comments to the authors.
Yes
Are the conclusions drawn adequately supported by the data shown?
If not, please explain in your comments to the authors.
No
Are you able to assess any statistics in the manuscript or would you recommend an additional
statistical review?
If  an  additional  statistical  review  is  recommended,  please  specify  what  aspects  require  further
assessment in your comments to the editors.
I am able to assess the statistics
Quality of written English
Please indicate the quality of language in the manuscript:
Not suitable for publication unless extensively edited
Declaration of competing interests
Please complete a declaration of competing interests, considering the following questions:
1. Have you in the past five years received reimbursements, fees, funding, or salary from an
organisation that may in any way gain or lose financially from the publication of this
manuscript, either now or in the future?
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose
financially from the publication of this manuscript, either now or in the future?
3. Do you hold or are you currently applying for any patents relating to the content of the
manuscript?
4. Have you received reimbursements, fees, funding, or salary from an organization that holds
or has applied for patents relating to the content of the manuscript?
5. Do you have any other financial competing interests?
6. Do you have any non-financial competing interests in relation to this paper?
If you can answer no to all of the above, write 'I declare that I have no competing interests' below. If
your reply is yes to any, please give details below.
I declare that I have no competing interests
I agree to the open peer review policy of the journal. I understand that my name will be included on my
report to the authors and, if the manuscript is accepted for publication, my named report including any 
attachments I upload will be posted on the website along with the authors' responses. I agree for my 
report to be made available under an Open Access Creative Commons CC-BY license 
(http://creativecommons.org/licenses/by/4.0/ ). I understand that any comments which I do not wish to 
be included in my named report can be included as confidential comments to the editors, which will not
be published.
I agree to the open peer review policy of the journal
Reviewer’s report
Title:  Curcumin and Inflammation in Non-alcoholic Fatty Liver Disease: a Randomized, Placebo
Controlled Clinical Trial
Version: 0 Date: 06 Jun 2019
Reviewer: Fernando Bril
Reviewer's report:
In  this  proof-of-concept  study,  Saadati  et  al  assessed  the  role  of curcumin  to  reduce  subclinical
inflammation in patients with NAFLD. The authors should be congratulated for a well-designed study.
However, the presentation and interpretation of their results must be revised before this manuscript is
ready for publication.
-Briefly, this is a negative study, where all comparisons between curcumin vs. placebo were
negative. Therefore, the study should be presented as such. Within group comparisons (i.e.,
before vs. after) have only minimal importance in this scenario, and conclusions should not be
driven by these.
-Please  re-write  the  manuscript  (results  and  discussion)  based  on  the  main  comparison  of
curcumin vs. placebo. Avoid statements claiming a significant action of curcumin based on
within group comparisons.
-Sample size calculation: please provide more details. What do the authors mean by 2 units? 2
pg/ml? What was the expected SD? Is this clinically relevant? Please justify.
-In  addition  to  IRB  approval,  was  this  clinical  trial  included  in  any  RCT  registry  (e.g.,
www.clinicaltrials.gov, etc.)? Please mention this under Methods.
-Table 1: % of smokers should be reported per column, not % per row.
-"3 capsules containing either 500mg curcumin or matched placebo per day after each meal for
12 weeks" is unclear. Please clarify dose. 500mg TID or 1500mg QD or 1500mg TID?
-There are several grammatical mistakes throughout the manuscript. I would suggest having it
revised by a native English speaker.
-No information is provided regarding physical activity and caloric intake between the groups
during the 12 weeks of the trial.
Are the methods appropriate and well described?
If not, please specify what is required in your comments to the authors.
Yes
Does the work include the necessary controls?
If not, please specify which controls are required in your comments to the authors.
Yes
Are the conclusions drawn adequately supported by the data shown?
If not, please explain in your comments to the authors.
No
Are you able to assess any statistics in the manuscript or would you recommend an additional
statistical review?
If  an  additional  statistical  review  is  recommended,  please  specify  what  aspects  require  further
assessment in your comments to the editors.
I am able to assess the statistics
Quality of written English
Please indicate the quality of language in the manuscript:
Not suitable for publication unless extensively edited
Declaration of competing interests
Please complete a declaration of competing interests, considering the following questions:
1. Have you in the past five years received reimbursements, fees, funding, or salary from an
organisation that may in any way gain or lose financially from the publication of this
manuscript, either now or in the future?
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose
financially from the publication of this manuscript, either now or in the future?
3. Do you hold or are you currently applying for any patents relating to the content of the
manuscript?
4. Have you received reimbursements, fees, funding, or salary from an organization that holds
or has applied for patents relating to the content of the manuscript?
5. Do you have any other financial competing interests?
6. Do you have any non-financial competing interests in relation to this paper?
If you can answer no to all of the above, write 'I declare that I have no competing interests' below. If
your reply is yes to any, please give details below.
I declare that I have no competing interests
I agree to the open peer review policy of the journal. I understand that my name will be included on my
report to the authors and, if the manuscript is accepted for publication, my named report including any 
attachments I upload will be posted on the website along with the authors' responses. I agree for my 
report to be made available under an Open Access Creative Commons CC-BY license 
(http://creativecommons.org/licenses/by/4.0/ ). I understand that any comments which I do not wish to 
be included in my named report can be included as confidential comments to the editors, which will not
be published.
I agree to the open peer review policy of the journal
Please review this paper.
user
Reviewer’s report
Title:  Curcumin and Inflammation in Non-alcoholic Fatty Liver Disease: a Randomized, Placebo
Controlled Clinical Trial
Version: 0 Date: 06 Jun 2019
Reviewer: Fernando Bril
Reviewer's report:
In  this  proof-of-concept  study,  Saadati  et  al  assessed  the  role  of curcumin  to  reduce  subclinical
inflammation in patients with NAFLD. The authors should be congratulated for a well-designed study.
However, the presentation and interpretation of their results must be revised before this manuscript is
ready for publication.
-Briefly, this is a negative study, where all comparisons between curcumin vs. placebo were
negative. Therefore, the study should be presented as such. Within group comparisons (i.e.,
before vs. after) have only minimal importance in this scenario, and conclusions should not be
driven by these.
-Please  re-write  the  manuscript  (results  and  discussion)  based  on  the  main  comparison  of
curcumin vs. placebo. Avoid statements claiming a significant action of curcumin based on
within group comparisons.
-Sample size calculation: please provide more details. What do the authors mean by 2 units? 2
pg/ml? What was the expected SD? Is this clinically relevant? Please justify.
-In  addition  to  IRB  approval,  was  this  clinical  trial  included  in  any  RCT  registry  (e.g.,
www.clinicaltrials.gov, etc.)? Please mention this under Methods.
-Table 1: % of smokers should be reported per column, not % per row.
-"3 capsules containing either 500mg curcumin or matched placebo per day after each meal for
12 weeks" is unclear. Please clarify dose. 500mg TID or 1500mg QD or 1500mg TID?
-There are several grammatical mistakes throughout the manuscript. I would suggest having it
revised by a native English speaker.
-No information is provided regarding physical activity and caloric intake between the groups
during the 12 weeks of the trial.
Are the methods appropriate and well described?
If not, please specify what is required in your comments to the authors.
Yes
Does the work include the necessary controls?
If not, please specify which controls are required in your comments to the authors.
Yes
Are the conclusions drawn adequately supported by the data shown?
If not, please explain in your comments to the authors.
No
Are you able to assess any statistics in the manuscript or would you recommend an additional
statistical review?
If  an  additional  statistical  review  is  recommended,  please  specify  what  aspects  require  further
assessment in your comments to the editors.
I am able to assess the statistics
Quality of written English
Please indicate the quality of language in the manuscript:
Not suitable for publication unless extensively edited
Declaration of competing interests
Please complete a declaration of competing interests, considering the following questions:
1. Have you in the past five years received reimbursements, fees, funding, or salary from an
organisation that may in any way gain or lose financially from the publication of this
manuscript, either now or in the future?
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose
financially from the publication of this manuscript, either now or in the future?
3. Do you hold or are you currently applying for any patents relating to the content of the
manuscript?
4. Have you received reimbursements, fees, funding, or salary from an organization that holds
or has applied for patents relating to the content of the manuscript?
5. Do you have any other financial competing interests?
6. Do you have any non-financial competing interests in relation to this paper?
If you can answer no to all of the above, write 'I declare that I have no competing interests' below. If
your reply is yes to any, please give details below.
I declare that I have no competing interests
I agree to the open peer review policy of the journal. I understand that my name will be included on my
report to the authors and, if the manuscript is accepted for publication, my named report including any 
attachments I upload will be posted on the website along with the authors' responses. I agree for my 
report to be made available under an Open Access Creative Commons CC-BY license 
(http://creativecommons.org/licenses/by/4.0/ ). I understand that any comments which I do not wish to 
be included in my named report can be included as confidential comments to the editors, which will not
be published.
I agree to the open peer review policy of the journal
assistant