| Methods |
Method of randomisation: states randomised by person not involved in study, in blocks of 4 based on body mass index
Assessor blinding: double‐blind placebo‐controlled trial
Intention to treat: carried out but no results given
Lost to follow‐up: intervention 5 dropped out; control 5 dropped out ‐ plus 13/10 withdrawn or excluded (unclear which arm)
Timing of intervention: 6 months
Length of follow‐up: 6 months |
| Participants |
Location: homes for elderly or sheltered housing, The Netherlands
101 participants
Inclusion criteria: 65 years or older, BMI 25kg/m2 or less
Exclusion criteria: cancer, gastrointestinal disease, therapeutic diet incompatible with supplementation, unable to respond to questionnaires or take supplement
Sex: 38 female, 29 male (completers)
Age: mean age 83y |
| Interventions |
a: 2 x 125ml daily oral liquid supplements with total of 250kcal and 8.75g protein, providing 30‐160% of US RDA of micronutrients
b: 2 x 125ml daily placebo with water, sweetener, cloudifier, thickening, flavouring, colour
Allocated: 52/49
Assessed: 34/34 |
| Outcomes |
Main outcomes:
Deaths and illness (combined)
Functional status ‐ cognitive function |
| Notes |
Emailed for separate illness and death data by allocation 09/01/2008, no response by 16 March 2008 so illness and death data not included |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
