Nagao 2007.
Methods | This trial was a randomised, double‐blind, controlled parallel clinical study with a randomisation ratio of 1:1 | |
Participants |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
DIAGNOSTIC CRITERIA:
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Interventions |
NUMBER OF STUDY CENTRES: 7 COUNTRY/ LOCATION: Japan/ Kanto district SETTING: medical institutions TREATMENT BEFORE STUDY: note: 2‐week run‐in 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 English in Obesity, a peer‐reviewed journal, and did not receive funding or outside support. The lead author is affiliated with Health Care Food Research Laboratories, Kao Corporation in Tokyo, Japan | |
Stated aim of study | Quote from study: "therefore, the present trial was conducted to clarify the body fat reducing effect of the continuous ingestion of a green tea extract (GTE) high in catechins in more than 200 Japanese women and men who were maintaining their usual lifestyles. We also examined the effects of a GTE high in catechins on risk factors of cardiovascular disease" | |
Notes | BMI: body mass index | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote from study: "this was a randomised double‐blind, controlled parallel multicenter trial" "randomisation was stratified by gender and BMI measured at the time of the run‐in period at each institution" Comment: method of randomisation not reported |
Allocation concealment (selection bias) | Unclear risk | Quote from study: "after the run‐in period, the subjects were allocated into two groups" Comment: allocation concealment not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote from study: "this was a randomised double‐blind, controlled parallel multicenter trial" Comment: no description of GTE product compared to placebo found, other than that the base for both was brewed green tea. 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 |