Takase 2008.
Methods | This was a randomised, double‐blind, placebo‐controlled, parallel‐group clinical trial with a randomisation ratio of 1:1.06 | |
Participants |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
DIAGNOSTIC CRITERIA:
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Interventions |
NUMBER OF STUDY CENTRES: NR ("multi‐facility") COUNTRY/ LOCATION: Japan SETTING: NR TREATMENT BEFORE STUDY: unknown |
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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 & Therapeutics, and all 6 authors are affiliated with Kao Corporation in the Health Care Food Research Laboratories; no sources of funding were reported | |
Stated aim of study | Quote from study: "the present study used visceral fat area measured in CT scans as a criterion for the selection of study participants to investigate the effects of daily consumption of a high‐dose tea catechin beverage on visceral fat and metabolic syndrome in obese females with large accumulations of visceral fat" | |
Notes | BMI: body Mass Index; CT: computerised axial tomography; 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 implemented as a multi‐facility, randomised, double‐blind, placebo‐controlled, parallel‐group trial" "based on the preliminary exam, participants were randomly assigned to either the catechin or the placebo group" "in this study, 101 individuals selected to participate as a result of prior screening were then randomly divided into two groups" Comment: method of randomisation not reported |
Allocation concealment (selection bias) | Unclear risk | Comment: not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote from study: "the catechin beverage and placebo beverage were flavoured to taste like a sports drink and except for their catechin content were formulated in the same way" 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 | 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: outcomes specified at the beginning were adequately investigated and reported |
Other bias | Low risk | Comment: appears to be free of other bias |