Karatzi 2013.
Study characteristics | ||
Methods | Randomised controlled trial, single‐blinded, cross‐over design | |
Participants | 17 healthy, non‐smoking male volunteers with a mean age of 28.5 ± 5.2 years and body mass index (BMI) of 24.4 ± 2.5 kg/m2 Exclusion criteria:
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Interventions |
Consumed within 15 minutes |
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Outcomes |
Assessed at fast and at 1 and 2 hours postprandially |
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Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "all volunteers consumed in a randomized order either a) 400 ml of beer & 400 ml water, b) 800 ml of dealcoholized beer (same amount of polyphenols), or c) 67 ml of vodka & 733 ml water" Comment ‐ method of randomisation was not described |
Allocation concealment (selection bias) | Unclear risk | Comment ‐ method of allocation concealment was not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment ‐ study was not blinded for participants |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | “The same trained observer who was blinded for the type of intervention performed all measurements" Comment ‐ blinding of outcome assessors was probably done |
Incomplete outcome data (attrition bias) All outcomes | Low risk | “Data from 16 subjects were available for the final analysis due to missing values related to poor quality of vascular recordings in at least one of the visits” Comment ‐ reasons for exclusion of a participant were reported and balanced across groups, so missing data should not affect the final analysis |
Selective reporting (reporting bias) For systolic blood pressure (SBP) | High risk | Comment ‐ study authors did not report SBP |
Selective reporting (reporting bias) For diastolic blood pressure (DBP) | High risk | Comment ‐ study authors did not report DBP |
Selective reporting (reporting bias) For mean arterial blood pressure (MAP) | Low risk | Comment ‐ study authors reported MAP with 95% confidence interval |
Selective reporting (reporting bias) For heart rate (HR) | Low risk | Comment ‐ study authors reported HR with 95% confidence interval |
Other bias (conflict of interest, industry sponsorship) | Low risk | “The authors declare that they have no conflict of interest” |
Other bias (was the study registered in clinical trials.gov/ was the protocol available?) | High risk | Comment ‐ protocol was not registered and study identifier was not reported |