Fantin 2016.
Study characteristics | ||
Methods | Randomised controlled trial, open‐label with cross‐over design | |
Participants | 18 healthy adults (12 male and 6 female) with mean age 34.2 years (range 25 to 53 years) Exclusion criteria:
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Interventions | 250 mL of red wine (12% of ethanol) | |
Outcomes | Heart rate, BP, and arterial stiffness, as assessed by QKD | |
Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “The subjects received the two days in random order” “The subjects were randomly allocated to either consuming alcohol on the first day (control day second) or the control day first” Comment ‐ method of randomisation was not reported |
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 ‐ participants and personnel were not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment ‐ outcome assessors were not blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Our study sample was composed of 21 healthy adult volunteer men and women. 3 of them decided not to go on with the study so the final sample was composed of 18 subjects" Comment ‐ study included only participants who finished the study, hence participant withdrawal did not affect results. 18 participants were included in the final analysis |
Selective reporting (reporting bias) For systolic blood pressure (SBP) | Low risk | Comment ‐ SBP data with SD were reported |
Selective reporting (reporting bias) For diastolic blood pressure (DBP) | Low risk | Comment ‐ DBP data with SD were reported |
Selective reporting (reporting bias) For mean arterial blood pressure (MAP) | High risk | Comment ‐ MAP data were not reported |
Selective reporting (reporting bias) For heart rate (HR) | Low risk | Comment ‐ HR data with SD were reported |
Other bias (conflict of interest, industry sponsorship) | Low risk | “The authors declare 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 |