Methods | Double‐blind, randomised, controlled cross‐over study The trial was conducted in New Zealand |
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Participants | 38 healthy volunteers. Age: over 40 years |
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Interventions | Intervention: high‐calcium skim powder milk. Control: replacement of usual liquid milk with 2 servings a day of skim non‐fortified powder milk. Trial duration: 4 weeks, with a minimum of 4 weeks of wash‐out between interventions. |
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Outcomes | Systolic blood pressure and ambulatory blood pressure | |
Notes | "For many people in the trial, the control skim milk provided additional calcium to the diet. This may explain the small reduction in office".. standing systolic blood pressure observed in the control group. Calcium intake was calculated using 24 hour food recalls. This study was supported by The New Zealand Dairy Board. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Stated "Randomized double‐blind controlled trial'. Double‐blind, randomised, controlled cross‐over study. "Each volunteer consumed each of the milks in randomised order." "The milk was provided to the volunteers as a dry powder." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Ambulatory blood pressure monitor. Automated oscillometric blood pressure monitor (A&D, Model UA‐751; A&D Medical Division, Milpitas, California, USA)." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Dropouts not reported |
Selective reporting (reporting bias) | Low risk | All primary outcomes were reported. |
Other bias | High risk | There were small differences (in different directions) between intervention and placebo participants in baseline office and ambulatory blood pressure, except for baseline systolic blood pressure: Skim milk 121 ± 14 and high‐calcium skim milk 125 ± 19. Controls may have accidentally received a calcium boost from the placebo milk that should be treated as a potential bias. |