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. 2009 Apr 15;2009(2):CD003288. doi: 10.1002/14651858.CD003288.pub3

Wouters 2002.

Methods Method of randomisation: not stated ‐ allocation concealment: B 
 Assessor blinding: not mentioned 
 Intention to treat: not possible 
 Lost to follow‐up: 3 (2‐taste, 1 consent) ‐ unclear which arm 
 Timing of the intervention: 3 months 
 Length of follow‐up: 3 months
Participants Location: Two psycho‐geriatric nursing homes in the Netherlands 
 42 patients 
 Inclusion criteria: 60 years or older, resident at least 2 months in nursing home, diagnosed with dementia syndrome, BMI less than 23 kg/m2 for men and 25 kg/m2 for women 
 Exclusion criteria: Cancer, terminal care, acute illness, severe gastrointestinal disorders, need for parenteral or enteral nutrition, therapeutic diet incompatible with supplementation 
 Sex: 31 female 4 male 
 Age: 85.3 (SD 8.4)/ 78.7 (SD 8.8)
Interventions a: Two 125ml tetrapaks, twice daily in morning and afternoon between meals 250 kcal/day 8.5g protein, 39.6g carbohydrate, 8.9g fat, vitamins and minerals 
 b: Two 125ml tetrapaks placebo containing water, cloudifier, flavourant, non‐caloric sweetener to resemble supplement in taste and appearance 
 Allocated: 21/21 
 Assessed: 19/16
Outcomes Main outcomes: mortality, activities of daily living 
 Additional outcomes: side‐effects of supplement, compliance 
 Measures of nutritional status‐ weight 
 compliance 
 Measures of dietary intake ‐energy and protein intake
Notes Classified as in long‐term care, malnourished, unwell, in‐patients
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear