Westerterp‐Plantenga 2005.
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 | |
Participants |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
DIAGNOSTIC CRITERIA:
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Interventions |
NUMBER OF STUDY CENTRES: NR COUNTRY/ LOCATION: Netherlands SETTING: NR TREATMENT BEFORE STUDY: 4 weeks' very‐low energy‐diet |
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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 Research, a peer‐reviewed journal, and was commercially funded by Novartis Consumer Health, Nyon, Switzerland | |
Stated aim of study | Quote from study: "therefore, we executed a follow‐up study on body weight maintenance with the aim of investigating whether the same green tea‐caffeine mixture may improve weight maintenance by preventing or limiting weight regain after weight loss of 5% to 10% in moderately obese subjects with a low or high habitual caffeine intake" | |
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: participants "were divided into two stratified groups according to sex, BMI, age, dietary restraint, resting energy expenditure (REE), and being either habitual low caffeine consumers or habitual high caffeine consumers.... Subsequently, within the low or high habitual caffeine consumption groups, subjects were further stratified according to the characteristics mentioned above and randomised to a prospective green tea‐caffeine mixture treatment group and a placebo group for the weight maintenance phase" "Within the low or high caffeine intake group, subjects were stratified according to sex, BMI, age, dietary restraint, and REE and 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: "a randomised placebo‐controlled double blind parallel trial in 76 overweight and moderately obese subjects, matched for sex, age, BMI, height, body mass, and habitual caffeine intake was conducted" Quote from study: "a double‐blind administration of the supplementation (green tea‐caffeine mixture or placebo) was carried out" Comment: no mention of effectiveness of blinding efforts. Intervention and placebo delivered as a capsule, capsules not described for appearance |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: all outcomes that study reported on 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: there appears to have been no attrition of participants requiring explanation, or other incomplete outcome data |
Selective reporting (reporting bias) | Low risk | Comment: outcomes specified at the beginning were adequately investigated and reported |
Other bias | Unclear risk | Comment: study funded by Novartis, maker of test product. Results were positive so we judged that there was an unclear risk of bias |