Suominen 2015.

Study characteristics
Methods	RCT. Parallel design with 2 arms. Duration: 1 year. Location: Finland.
Participants	Inclusion criteria: individuals with Alzheimer's disease living with a spouse, aged > 64 years, able to reach the study place by taxi, able to stand on a scale, resident in the Helsinki metropolitan area, absence of terminal disease, an estimated life expectancy of at least half a year (confirmed by medical records). Exclusion criteria: not mentioned. Number randomised: 99 couples (intervention group, n = 50; control group, n = 49). Attrition: 78 couples completed the study (intervention group, n = 40; control group, n = 38). Gender split: 31% males, 69% females. Age: mean (SD), intervention 78.2 years; control 76.8 (5.9) years. Nutritional status: assessed by MNA. Intervention % with score < 17: 0%; 17 ‐ 23.5: 43%; > 23.5: 57%. Control % with score < 17: 0%; 17 ‐ 23.5: 37%; > 23.5: 63%.
Interventions	Intervention: participants received dietary advice plus ONS if required in the form of tailored nutritional guidance on the basis of the food diaries, results of weight measurement, home visits and discussions with the participants and their caregivers held every 3 months; oral nutritional supplements provided according to participants' needs. Control: participants received no dietary advice and no ONS in the form of a written guide on nutrition of older people.
Outcomes	Primary outcome: change in weight* of individuals with Alzheimer's disease. Secondary outcomes: changes in protein intake* and other nutrients, health‐related QoL* and rate of falls.
Publication details	Language: English. Funding: support from Finland’s Slot Machine Association (RAY) and Nutricia provided the protein supplements. The funders had no role in the design, analysis or interpretation of data or in writing, reporting or deciding whether to submit this article for publication. The authors are independent researchers unassociated with the funders. Publication status: peer‐reviewed journal.
Notes	Study aimed to examine the effect of tailored nutritional guidance on nutrition, health‐related QoL and falls in people with Alzheimer disease. The authors report no change in weight between the groups, however they cannot provide the data. They also emailed that they collected data on energy intake, but these were not reported in the manuscript and were not received from the authors either.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participating couples were randomly allocated according to a computer‐generated, blocked randomisation list. The block size was six, and the randomisation took place between August 2010 and January 2011. A person unrelated to the investigation and unfamiliar with the procedure performed the randomisation.
Allocation concealment (selection bias)	Unclear risk	Quote: A person unrelated to the investigation and unfamiliar with the procedure performed the randomisation. It remains unclear how, and at which time‐point this was done.
Blinding (performance bias and detection bias) Clinical outcomes	Low risk	It is unlikely that participants were unaware of group assignment. Thus assume that the trial was unblinded. However, this is unlikely to influence clinical outcomes.
Blinding (performance bias and detection bias) Functional outcomes	High risk	The trial was unblinded. Functional outcomes could have been influenced by lack of blinding.
Blinding (performance bias and detection bias) Nutritional outcomes	High risk	The study was unblinded. Nutritional outcomes could have been influenced by lack of blinding.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not descrobed 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	Unclear risk	Judged to be unclear, as low risk for clinical outcomes and high risk for functional and nutritional outcomes.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Out of 99 participating couples, 78 completed the study (intervention group n = 40; control group n = 38). Reasons for drop out are well‐explained (moving to another city, moving to long‐term care, death, food records not received).
Selective reporting (reporting bias)	High risk	The data for change in weight (primary outcome) are not available. Authors only report that there were no differences. As data are not available, this is judged as high risk. The study protocol is available, Jyvakorpi SK, Trials 2012, and all outcomes are reported in different papers.
Other bias	Low risk	Baseline characteristics were similar between groups.