Schwenk 1999.

Study characteristics
Methods	RCT. Parallel design with 2 arms. Duration: 8 weeks. Location: Germany.
Participants	Inclusion criteria: HIV positive adults who had lost > 5% of usual weight or who were actively losing weight, > 3% in last month. Exclusion criteria: unable to swallow usual food, severe lactose intolerance, prescription of any ONS, nutritional counselling, hormonal or appetite stimulants, enteral or parenteral nutrition during the previous 3 months. Number randomised: 50 participants (intervention group, n = 26; control group, n = 24). Attrition: 5 drop outs (intervention group, n = 2; control group, n = 3). Gender split: 47 males, 3 females. Age: mean (SD) intervention group 39.4 (9.2) years; control group 39.5 (10.2) years). Nutritional status: mean (SD) BMI, intervention group 1 19.6 (2.3) kg/m2; intervention group 2 19.9 (2.1) kg/m2.
Interventions	Intervention (intervention group 1): particpants received ONS in the form of oral nutritional supplements (0.6 ‐ 1.5 kcal/mL) to increase energy intake by 600 kcal. Intervention (intervention group 2): participants received dietary advice in the form of dietary counselling to increase food intake by 600 kcal using household food items.
Outcomes	Survival*, change in body cell mass and change in weight*, change in energy intake*, hospital admissions*, Cost‐effectiveness planes and cost‐effectiveness acceptability curves, QALYs.
Publication details	Language: English. Funding: Nestle Clinical Nutrition, Germany. Publication status: peer‐reviewed journal.
Notes	Additional data and information obtained from authors.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Information from author, block randomisation derived using random numbers.
Allocation concealment (selection bias)	Low risk	Sealed envelopes prepared by a person not involved in the study.
Blinding (performance bias and detection bias) Clinical outcomes	Low risk	Information from author indicates that the study was not blinded but unlikely that lack of blinding would influence assessment of clinical outcomes.
Blinding (performance bias and detection bias) Functional outcomes	High risk	Information from author indicates that the study was not blinded and likely that lack of blinding would influence assessment of functional outcomes.
Blinding (performance bias and detection bias) Nutritional outcomes	High risk	Information from author indicates that the study was not blinded and likely that lack of blinding would influence assessment of nutritional outcomes.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not blinded 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	Incomplete blinding and likely that assessment of some outcomes could be influenced by lack of blinding.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Fully reported and similar in each group. 3/24 (12%) dropouts in control (dietary counselling) group and 2/26 (8%) dropouts in intervention (supplement) group. Reasons for drop out were opportunistic infections n = 4 and change of residence n = 1.
Selective reporting (reporting bias)	Unclear risk	No protocol identified. All specified outcomes reported but data were not in a form usable for meta analysis. Data on weight change were reported as % change in area under the curve and data on energy intake was reported as mean calories per kg, therefore mean change (SD) obtained from authors. Data on number of hospital admissions confirmed with the author.
Other bias	Low risk	Baseline variables given, groups similar at baseline.