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. 2020 Jul 1;2020(7):CD012787. doi: 10.1002/14651858.CD012787.pub2

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:
  • Individuals > 55 years old

  • Individuals with hypertension or diabetes, any arrhythmia, heart failure, valvular heart disease, malignancy, renal failure, body mass index > 30 kg/m², or on hormone replacement therapy

Interventions 250 mL of red wine (12% of ethanol)
Outcomes Heart rate, BP, and arterial stiffness, as assessed by QKD
Notes
  • Participants were asked not to drink for 24 hours before 24‐hour ambulatory readings of the first day

  • Investigators did not record which type of food they ate during the study day

  • None of the participants ingested caffeine during study days

  • None of the participants indulged in binge drinking during the study

  • None of the participants was involved in intense physical activity during the study

  • Alcohol was ingested between 1830 hours and 0430 hours

  • We calculated MAP from SBP and DBP

  • Readings were taken approximately every half hour with an ambulatory BP monitor

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