Pivi 2011.

Study characteristics
Methods	RCT. Parallel design. Duration: 6 months. Location: Brazil.
Participants	Inclusion criteria: > 65 years old with probable Alzheimer's disease. Exclusion criteria: other forms of dementia; receiving tube feeding; diabetes or renal disease; Diagnosis: Alzheimer's disease. Number randomised: 90 (intervention groups, dietary advice n = 29 and oral nutritional supplements n = 30; control group, n = 31). Attrition: fully described ‐ dietary advice group: 4/29 (14%); oral nutritional supplements group: 4/30 (13%); control group: 4/31 (13%). Gender split: (32%) male, (68%) female. Age: mean (SD) 75.2 years. Nutritional status: not reported.
Interventions	Intervention (intervention group 1): participants received dietary advice in the form of 10x classroom interactive education program delivered to caregivers and participants. Intervention (intervention group 2): particpants received ONS in the form of oral nutritional supplements twice daily for 6 months. Control: participants received no dietary advice in the form of monthly assessments with no intervention.
Outcomes	Mortality; weight; BMI; arm circumference and MAMC; TSF thickness; total protein; total lymphocyte count.
Publication details	Language: English. Funding: commercial / non‐commercial funding ‐ Ministry of Education; Abbott Laboratories. Publication status: peer‐reviewed journal.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "subjects were randomised into three groups.....". Judged as insufficient information.
Allocation concealment (selection bias)	Unclear risk	Not described.
Blinding (performance bias and detection bias) Clinical outcomes	Low risk	Blinding not described but assessment of mortality unlikely to be influenced by lack of blinding.
Blinding (performance bias and detection bias) Functional outcomes	Unclear risk	No functional outcomes assessed.
Blinding (performance bias and detection bias) Nutritional outcomes	Low risk	Blinding not described and assessment of nutritional status unlikely to be influenced by lack of blinding. Nutritional intake not assessed.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not described and likely that researchers and participants were aware of group allocation as this was a nutritional intervention. It is possible that assessment of some outcomes was influenced by lack of blinding.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Not described but unlikely that the outcomes assessed would be influenced by lack of blinding.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Fully described and similar amounts in each group. Overall 13% attrition. Dietary advice: 4/29 (14%); oral nutritional supplements group: 4/30 (13%); control group: 4/31 (13%).
Selective reporting (reporting bias)	Unclear risk	No protocol identified. All outcomes described in the methods reported but not possible to judge overall.
Other bias	Unclear risk	Baseline characteristics compared and no differences between groups but nutritional status not an inclusion and not reported at baseline, therefore not possible to judge the influence of baseline nutritional status on outcomes.