title: Incorrect statistical method in parallel-groups RCT led to unsubstantiated conclusions.
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.
authors.affiliation: Nutrition Obesity Research Center and Department of Biostatistics, University of Alabama at Birmingham, Ryals Public Health Building, Room 140J, Birmingham, AL, 35294, USA. dallison@uab.edu.|School of Public Health, University of Alabama at Birmingham, Ryals Public Health Building, Room 140J, Birmingham, AL, 35294, USA. dallison@uab.edu.
authors.forename: David B
authors.initials: DB
authors.lastname: Allison
authors.affiliation: School of Engineering, University of Alabama at Birmingham, Birmingham, AL, 35294, USA.
authors.forename: Lisa H
authors.initials: LH
authors.lastname: Antoine
authors.affiliation: Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, 35294, USA.
authors.forename: Brandon J
authors.initials: BJ
authors.lastname: George
mesh_terms: D001628:Beverages; D001937:Brassica / Q000737:chemistry*; D002784:Cholesterol / Q000097:blood*; D005638:Fruit; D006801:Humans; D014675:Vegetables
chemical_list: D002784:Cholesterol
keywords: Cholesterol; Fruit; Nutrition; Statistical analyses; Vegetable