TY - JOUR
T1 - Evaluation of randomized controlled trials of foods with functional claims request
T2 - The learning outcomes from studies in Japan
AU - Tanemura, Nanae
AU - Hamadate, Naobumi
AU - Urushihara, Hisashi
N1 - Funding Information:
This research was supported by a research grant from the Keio University Academic Development Funds from Keio University to Dr. Nanae Tanemura.
Publisher Copyright:
© 2018 Elsevier Ltd
PY - 2018/3/1
Y1 - 2018/3/1
N2 - A new system for foods with functional claims (FFC) was implemented in April 2015. The efficacy of FFC must now be proven by systematic review or randomized clinical trials (RCTs). The aim of this study was to establish the scientific reporting quality of RCTs on the efficacy of FFC and to identify areas that require improvement. The reporting quality of 33 RCT papers on 31 FFC that were received between April 1, 2015 and December 31, 2016 were analyzed by two experts with regard to consistency with the 29 Consolidated Standards of Reporting Trials (CONSORT) items. RCTs on FFC reported 13.8 (47.6%) of the CONSORT items, which is similar to those on FOSHU. There were 7 least reported items, including study design. Determining the reporting quality of FFC studies is an important way of identifying items that require improvement in future papers.
AB - A new system for foods with functional claims (FFC) was implemented in April 2015. The efficacy of FFC must now be proven by systematic review or randomized clinical trials (RCTs). The aim of this study was to establish the scientific reporting quality of RCTs on the efficacy of FFC and to identify areas that require improvement. The reporting quality of 33 RCT papers on 31 FFC that were received between April 1, 2015 and December 31, 2016 were analyzed by two experts with regard to consistency with the 29 Consolidated Standards of Reporting Trials (CONSORT) items. RCTs on FFC reported 13.8 (47.6%) of the CONSORT items, which is similar to those on FOSHU. There were 7 least reported items, including study design. Determining the reporting quality of FFC studies is an important way of identifying items that require improvement in future papers.
KW - CONSORT statement
KW - Efficacy
KW - Foods with functional claims
KW - Japan
KW - Randomized controlled trial
KW - Reporting quality
UR - http://www.scopus.com/inward/record.url?scp=85042919778&partnerID=8YFLogxK
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U2 - 10.1016/j.jff.2017.12.066
DO - 10.1016/j.jff.2017.12.066
M3 - Article
AN - SCOPUS:85042919778
SN - 1756-4646
VL - 42
SP - 248
EP - 253
JO - Journal of Functional Foods
JF - Journal of Functional Foods
ER -