Abstract

The article by Aiso et al. titled “Compared with the intake of commercial vegetable juice, the intake of fresh fruit and komatsuna (Brassica rapa L. var perviridis) juice mixture reduces serum cholesterol in middle-aged men: a randomized controlled pilot study” does not meet the expected standards of Lipids in Health and Disease. Although the article concludes that there are some significant benefits to their komatsuna juice mixture, these claims are not supported by the statistical analyses used. An incorrect procedure was used to compare the differences in two treatment groups over time, and a large number of outcomes were tested without correction; both issues are known to produce high rates of false positives, making the conclusions of the study unjustified. The study also fails to follow published journal standards regarding clinical trial registration and reporting.

Highlights

  • We respond to the commentary on our article by Allison et al As an overview of the issues they raise, we have selected the following statement from their commentary.“ the article concludes that there are some significant benefits to their komatsuna juice mixture, these claims are not supported by the statistical analyses used

  • We read with interest the paper by Aiso et al [3] reporting results of an randomized controlled trials (RCTs) of the effects of consumption of a commercial vegetable juice to that of the intake of fresh fruit and komatsuna (Brassica rapa L. var. perviridis) juice on serum cholesterol in men

  • Upon reading it became clear that incorrect statistical analyses were used, that the conclusions drawn in the paper are not supported by the analyses reported, and that there is insufficient adherence to RCT reporting guidelines [4], making it further difficult to determine the appropriateness of the analyses and the extent to which they adhere to original analytic plans

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Summary

Background

The conduct of rigorous randomized controlled trials (RCTs) is essential for progress in nutrition-related research [1]. For total and LDL cholesterol on which Aiso et al’s conclusion claim is based, Aiso et al do report the means and standard deviations for each variable within each of the treatment and control groups both at baseline and at endpoint. Using this information, we can implement choice a above. We believe that the authors should provide documentation of clinical trial registration

Conclusions
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Conclusion

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