Maki 2009.
Methods | This was a randomised, placebo‐controlled, double‐blind trial, with a treatment to control randomisation ratio of 1:0.97 | |
Participants |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
DIAGNOSTIC CRITERIA:
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Interventions |
NUMBER OF STUDY CENTRES: 2 COUNTRY/ LOCATION: USA/Provident Clinical Research (Bloomington, IN) and Merithen Research (St Petersburg, FL) SETTING: clinical research sites TREATMENT BEFORE STUDY: unknown |
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Outcomes |
OUTCOME(S) (as stated in the protocol/registered trial documents): PRIMARY OUTCOME(S): changes in body fat mass SECONDARY OUTCOME(S): changes in body weight OTHER OUTCOME(S): NR |
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Study details | STUDY TERMINATED BEFORE REGULAR END: no | |
Publication details | This study was published in English in The Journal of Nutrition, a peer‐reviewed journal, and was supported by Kao Corporation in Tokyo, Japan | |
Stated aim of study | Quote from study: "the present study was designed to evaluate the effects of a green tea catechin‐containing beverage on body composition and fat distribution in overweight and obese adults in the United States during exercise‐induced weight loss" | |
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 clinical trial" Comment: method of randomisation not reported |
Allocation concealment (selection bias) | Unclear risk | Comment: not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote from study: "study beverages were packaged in identical, single‐serving containers. The study products were labelled and coded in such a manner that subjects and staff were unaware of which product each participant was receiving. The beverages had similar sensory characteristics. Internal pretrial testing showed no difference in preference or palatability ratings between the active and control beverages" Comment: no mention of effectiveness of blinding efforts |
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: the attrition in this study was higher than in most (84% in intervention and 79% in controlled group completed the study). Authors adequately accounted for attrition. However, the reasons for not completing the study were adequately described with the exception of participants who were lost to follow up (similar number in both groups). Therefore, we assessed the risk of bias as low. |
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 |