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 |