Evidence map›Paper›PMID 39203880›Full record

ReviewNutrients2024

Research Quality of Clinical Trials Reported for Foods with Function Claims in Japan, 2023-2024: Evaluation Based on a Revised Tool to Assess Risk of Bias in Randomized Trials.

Hiroharu Kamioka, Jun Kitayuguchi, Hideki Origasa, Kiichiro Tsutani

Abstract readReview
In one paragraph

Review in Nutrients, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Hiroharu KamiokaFaculty of Regional Environment Science, Tokyo University of Agriculture, 1-1-1 Sakuragaoka, Setagaya-ku 156-8502, Tokyo, Japan.
Jun KitayuguchiPhysical Education and Medicine Research Center Unnan, 328 Uji, Unnan City 699-1105, Shimane, Japan.
Hideki OrigasaInstitute of Statistical Mathematic, 10-3 Midori-cho, Tachikawa City 190-8562, Tokyo, Japan.
Kiichiro TsutaniThe Institute of Seizon and Life Sciences, 4-5-1 Ginza, Chuo-ku 104-0061, Tokyo, Japan.

Funding

Grant-in-Aid for Scientific Research (C) from the Ministry of Edu-cation, Culture, Sports, Science and Technology (MEXT), Japan 24K14658
6 · The paper itself

Abstract

backgroundThe Foods with Function Claim was introduced in Japan in April 2015 to make more products available that are labeled with health functions. A product's functionality of function claims must be explained by the scientific evidence presented in clinical trials (CTs) or systematic reviews, but the quality of recent CTs is unclear. The purpose of this study was to evaluate the risk of bias (RoB) using "a revised tool to assess risk (RoB 2)" published in 2018 for notifications based on all recent CTs published on the Consumer Affairs Agency website.

methodsA total of 38 submitted papers based on CTs that were published on the Consumer Affairs Agency website during the period from 1 January 2023 to 30 June 2024 were eligible. The RoB 2 tool provides a framework for considering the risk of bias in the findings of any type of randomized trial. This tool with five domains was used to evaluate the quality of research methods.

resultsEligible CTs were assessed as "low risk" (11%,

conclusionOverall, the quality of the latest CTs submitted after 2023 was very low, occurring in all five domains, and was most serious for "bias in selection of the reported result (Domain 5)".

Indexed as

BiasRandomized Controlled Trials as TopicFood LabelingFunctional FoodHumansJapanResearch DesignRisk Assessmentclinical trialfunctionalityhealthy foodrandomized controlled trialrisk of bias

Identifiers

PMID39203880
PMCPMC11357381

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.