Suzuki 2009.
Methods | This study was a randomised double‐blind, placebo‐controlled trial with a parallel design with a treatment to control randomisation ratio of 1:1.05 | |
Participants |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
DIAGNOSTIC CRITERIA:
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Interventions |
NUMBER OF STUDY CENTRES: NR COUNTRY/ LOCATION: Japan SETTING: NR TREATMENT BEFORE STUDY: note: 2‐week observation period |
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Outcomes |
OUTCOME(S) (as stated in the protocol/registered trial documents): PRIMARY OUTCOME(S): unknown SECONDARY OUTCOME(S): unknown OTHER OUTCOME(S): unknown |
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Study details | STUDY TERMINATED BEFORE REGULAR END: no | |
Publication details | This study was published in Japanese in the journal Japanese Pharmacology and Therapeutics and no sources of support were declared by the study authors | |
Stated aim of study | Quote from study: "our aim in this study was to measure visceral fat area in women of all ages and, with full regard for safety, establish whether there is an effect reducing body fat in women" | |
Notes | BMI: body mass index; LDL: low density lipoprotein; NR: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote from study: "this study was conducted as a placebo‐controlled randomised double‐blind trial run in parallel groups for comparison purposes" Comment: method of randomisation not reported |
Allocation concealment (selection bias) | Low risk | Quote from study: "a third party not directly involved in the study [StatCom Co. Ltd (Tokyo; President: Hirokuni Amari)] randomly divided qualifying participants into two groups" Comment: method of allocation concealment not reported; however, due to the use of a third party company to allocate participants into 2 groups, we judged there to be a low risk of bias |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote from study: "this study was conducted as a placebo‐controlled randomised double‐blind trial run in parallel groups for comparison purposes" "IRB [review committee] verified prior to implementation of the study that there was no discernible difference between test beverages in appearance, taste or container (steel cans)." Comment: No mention of effectiveness of blinding efforts. No mention of whether researchers and staff were blinded to study components. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote from study: Comment: all outcomes on which the study reported were objective and measured by assessors. Therefore, whether or not assessors were blinded, risk of detection bias was assessed as low |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: authors adequately accounted for attrition |
Selective reporting (reporting bias) | Low risk | Comment: all outcome measurements stated in methods section were reported in the results |
Other bias | Unclear risk | Comment: 3 authors are affiliated with Soiken, Inc. and participants had previously registered as volunteers with Soiken, Inc; nature of corporate support for study is unclear |