Aquilani 2008.
Methods | Randomised clinical trial, Italy | |
Participants | 48 adults hospitalised with subacute stroke, cognitive dysfunction (< 20 in the mini‐mental state examination) and independent in their alimentation. They were at nutritional risk due to stroke. Male:Female = 27:21 Mean age = 73 years (experimental group), 71 years (control group) Exclusion criteria: aphasic patients, patients with chronic renal failure or diabetes on hypoglycaemic therapy, or both |
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Interventions | Experimental group: Oral caloric‐protein supplement for 21 days, containing 200 ml mixture of cubit an, nutricia, Italy providing 250 calories, 20 g protein, 28,2 g carbohydrates and 7 g lipids (n = 24) Control group: No intervention (n = 24) |
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Outcomes | Anthropometric and nutritional (3‐day diary) variables, cognitive function (MMSE) Weight, height, BMI, daily caloric and macronutrient intake |
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Study dates | Not stated | |
Notes | We contacted the authors on 27th September 2015 by email: labmio@unipv.it. We received an initial reply, but did not receive a reply for our follow‐up questions. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation where performed using SAS statistical tool |
Allocation concealment (selection bias) | Unclear risk | The description of allocation concealment was too unclear to permit judgement of low or high risk of bias. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | The study reports to be "double blinded", but does not explicitly describe how. The physician who evaluated the MMSE score was blinded to the supplementation and was different from the physician who prescribed the supplementation. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The number of participants with incomplete data was not reported. |
Selective reporting (reporting bias) | Unclear risk | No protocol could be obtained and the trial did not report all‐cause mortality and serious adverse events. |
For‐profit bias | Unclear risk | It was unclear how the trial was funded. |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |