Diepvens 2005.
Methods | This study was a randomised, double‐blind, placebo‐controlled, parallel trial with a randomisation ratio of 1:1 | |
Participants |
INCLUSION CRITERIA:
EXCLUSION CRITERIA: NR DIAGNOSTIC CRITERIA:
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Interventions |
NUMBER OF STUDY CENTRES: NR COUNTRY/ LOCATION: the Netherlands SETTING: NR TREATMENT BEFORE STUDY: 3 days of energy balanced diet before rest of study |
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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 The British Journal of Nutrition, a peer‐reviewed journal, and was commercially supported by Unilever food and Health Research Institute, Unilever R&D Vlaardingen, Vlaardingen, the Netherlands, with Slim‐Fast diet products donated by Unilever Bestfoods Nederland BV | |
Stated aim of study | Quote from study: "the aim of the present study was therefore to investigate whether GT [green tea] ingestion, independent of habitual caffeine intake, increased REE [resting energy expenditure] and substrate oxidation, whether this effect was present after a 4‐week administration of GT along with a LED (meal replacement diet plan) and whether GT ingestion during the LED offset the expected reduction in REE. Furthermore, we investigated the effect of a 12‐week GT administration during the LED on body weight and fat loss. We hypothesised that GT might increase REE and fat oxidation compared with PLAC [placebo], and that this effect might be present after a 4‐week ingestion of GT along with a LED (meal replacement diet plan). We further hypothesised that GT might offset the reduction in REE that is expected to occur during the LED and that GT might stimulate the loss of body weight and fat" | |
Notes | BMI: body mass index; NR: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote from study: "the two groups were randomly assigned to the two treatments" 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: "a double‐blind, placebo‐controlled, parallel design was adopted" "In addition, the subjects ingested three capsules (hard gelatine, size no. 1) of PLAC (maltodextrin) or GT three times daily..." Comment: effort appears to have been made to make capsules uniform in appearance. 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: investigators specified enrolment details and there does not appear to have been any attrition of participants |
Selective reporting (reporting bias) | Low risk | Comment: outcomes specified at the beginning were adequately investigated and reported |
Other bias | Low risk | Comment: study funded by Unilever, maker of meal replacement drink product. One author was affiliated with Unilever Food and Health Research Institute. Source of capsules with green tea or placebo is unclear. Results were not positive so we judged that there was a low risk of bias |