Effect of Fermented Red Ginseng Concentrate Intake on Stool Characteristic, Biochemical Parameters, and Gut Microbiota in Elderly Korean Women

Round 1

Reviewer 1 Report

The manuscript presents an interesting study. The title is correct and clear, and the summary is well-ordered and compressive. I do not have any consideration in this section.

However it does have shortcomings that need to be addressed before any further considerations should be made.
First, the use of English needs to be corrected. There are far too many grammatical and style errors throughout the text. 

In general, the results and the discussion are well expressed. 

Conclusion
This section needs to be better explained. However, there will be no future studies? I recommend the authors put de something adds two sentences referring them to future studies.

I recommend that authors follow the same format for all references.

For improvement, the manuscript should be revised according to the above suggestions and those of other reviewers. In my honest opinion, I suggest a minor revision of the article. The authors have done work that provides interesting results.

Author Response

According to your review, we revised and updated the manuscript and attached it as a file.

Author Response File: Author Response.docx

Reviewer 2 Report

Lee and colleagues conducted a study on the effect of fermented red ginseng concentrate on overall health and gut microbiota in elderly Korean women.

Unfortunately, the study methodology is not appropriate and provokes many questions.

The authors state, "extensive clinical applications require a well-designed study to demonstrate the safety and effectiveness of FRG intake." The best option to evaluate the effect of the intervention is a randomized, double-blind, placebo-controlled  trial.  Study presented for review is poorly designed: neither randomization nor control group was applied.

This condition decreased the scientific value of obtained results and  brings into question the credibility of the presented analyses.

 

Other objections:

1. A considerable part of the introduction does not explain the study subject.
2. Exclusion criteria were not clear.

Authors have mentioned :  row 95 -98 …..participation in other clinical  research trials during the study period, and eating FRG other than that provided in the  study.  There is no explanation which period of eating ERF is taken under consideration. Before study?  There is no information of how many participating women have taken FGR before the study.

 

3. Unfortunately the authors did not explain what are criteria of the overall Health. According to the text overall health was limited to stool shape, bowel movements an blood chemistry. This parameter do not reflects an overall health according to WHO definition.

 

4. The study was divided into three time points: 3, 6, and 9 weeks. The first 3 weeks (0 to 3) was the run-in period, during which all participants maintained their usual dietary habits. Why do the authors call it “intestinal washout period”?

 

5. Most questionable are obtained results. Moreover, the presented data raises many doubts.

According to data, after 3 weeks of intervention stools were  more solid, but surpassingly  the frequency was  7 stool per day (Figure 2). Can we call 7 movements per day an improvement?   What is average frequency of stools in  women above 50 years of age  in Korea?

Authors stated that FRG improved glucose levels. In all study points glucose levels were within normal values. Why a slight decrease in normal levels is called an improvement?

As a result of intervention the triglyceride (TG) levels decreased sharply from 200.7 at TP1 to 155.4  at TP2.  What is the explanation for such a high level  of TG in T1?

The descriptions of  corelations between biomarker taxa, biochemical activity and stool indices  are complicated and not easy to follow.

Can stool shape be named a stool activity (Chapter 3.5,  Figure 4)?

 

Author Response

According to your review, we revised and updated the manuscript and attached it as a file.

Author Response File: Author Response.docx

Reviewer 3 Report

1. The topic of this study involves “overall health”，which is a large scope rather than a research on specific disease. How to define “overall health” or what indicators are used to reflect it? Whether fecal morphology, blood glucose, lipoprotein can reflect "overall health"?
2. No control group was set. The number of samples is 29 and it is a little small for the research of "overall health".
3. The author mentioned the role of SCFAs when discussing the correlation between microorganisms and physiological indexes. I suggested that it is necessary to determine the content of SCFAs and establish the correlation between SCFAs content and physiological indexes.
4. The author's analysis of metabolic pathways and flora needs to be more in-depth. There are many significant related pathways in the “Results”, but there is little in-depth discussion between physiological indicators and flora and specific metabolic pathways in the part “Discussion”.

Author Response

According to your review, we revised and updated the manuscript and attached it as a file.

Author Response File: Author Response.docx

Reviewer 4 Report

Thank you for the opportunity to revise the article “Effect of fermented red ginseng concentrate intake on the overall health and gut microbiome of elderly Korean women” by Songhee Lee et al.

This is a Korean longitudinal pilot study in which 29 healthy female volunteers were treated with red ginseng concentrate for 3 weeks and tested via urine, blood, and feces analysis and examination of stool shape and bowel movements. As known, Ginseng is an herbal medicine associated with gut microbiome health and potentially beneficial effects on the metabolic profile (may be effective against obesity, dyslipidemia, and diabetes) supported by molecular mechanisms that are not perfectly known. Researchers found, after administration of red ginseng concentrate (steamed and dried to enhance ginseng therapeutic activity) that there was an improvement in stool shape and frequency of bowel movements, in biochemical parameters linked with kidney and liver functionality, as well as cholesterol, triglycerides and glycemia, and positive modification of gut microbiome.

The topic of the article is interesting, and the authors conducted good quality work; the writing is clear and the study method appropriate. I consider this paper of conspicuous interest to readers, and I suggest only the correction of some minor grammatical mistakes.

Author Response

According to your review, we revised and updated the manuscript and attached it as a file.

We revised the manuscript according to your instructions, and requested an English proofreading company (Editige).

Round 2

Reviewer 2 Report

 I am satisfied with some changes and answers.

A few significant changes have to be done in the manuscript

1. Line 494 . Therefore, the results of this study were directly related to FRG
   intake as they were based on this design. All participants displayed active participation and compliance, and there were adverse events, deaths, or dropouts during the 9-week study period.???????

The death was directly related to FRG intake? A very poor outcome!

2. In the title and in the text the term „ bowel activity” should be replaced by stool characteristic.

Bowel activity is a very broad problem, but the authors analyzed only stool frequency and consistency.

The term „ stool shape” should be replaced by stool consistency ( loose stool does not have a shape)

3. There are discrepancies in the description, which should be clarified.

Exclusion criteria(3) Those who have already participated in another study or were taking other red ginseng preparations and probiotics except for FRG provided in this study.???

line 223 None of the participants took FRG prior to participating in this study.

line 83 Therefore, in this study, the intake of probiotics and red ginseng previously taken was stopped for 3 weeks before starting the study.

 

4. Not clear: line 101 During the 9-week study period, the participants consumed only FRG that was provided by us.

According to the study, design participants consumed FRG for only 3 weeks.

5. line 151 2.5. Bowel activity
   We surveyed the bowel activity for the shape of stool and frequency of bowel movements, respectively.

Bowel activity relates to the complicated phenomenon of gut motor function, not the shape of the stool and frequency of bowel movements.

6. Figure 2.

Y-axes should be appropriately labeled.

The legend should be more precise.

7. Line116

hyperlipidemia (triglycerides ≥ 400 mg/dL)

in guidelines, hiperlipidemia is defined as TG>200 mg. It is very important according to study results.

 

Author Response

Thank you for your review of this manuscript.
According to your review, I revised and updated the manuscript.

Author Response File: Author Response.docx

Reviewer 3 Report

The authors answered all my questions.

Author Response

Thank you for your review of this manuscript.