|- candidate number||22970|
|- NTR Number||NTR5433|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-okt-2015|
|- Secondary IDs||METc 2015/038 METc UMCG|
|- Public Title||Dairy.com|
|- Scientific Title||Compliance of dairy products versus oral nutrition supplements in patients with a risk for malnutrition.|
|- Healt Condition(s) or Problem(s) studied||Malnutrition, Risc|
|- Inclusion criteria||- Risk for malnutrition|
- Aged 18 years and older
- Albe to eat orally and without the help of others
- Able to understand, speak, and write in the Dutch language
|- Exclusion criteria||- Use of oral nutrition supplements in the past six months at time of inclusion.|
- Receiving treatment of a dietician at time of inclusion.
- High current daily protein intake.
- Protein requirements >18 gram protein per day.
- Prescription of oral nutrition supplements by the dietician.
- Contraindication for dairy products.
- Protein restriction (°‹0.8 gram protein / kg actual body weight)
- Diseases associated with a reduced protein intake advice
- Fluid restriction (°‹1500 ml).
- Bound to wheel chair, longterm (>6 months).
- Eating disorder.
- Distance from home to the UMCG is greater than 70 km.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||13-okt-2015|
|- planned closingdate||15-feb-2016|
|- Target number of participants||0|
|- Interventions||High-protein products in addition to the normal intake: dairy products versus oral nutrition supplements. Aiming at a total intake of 1.0 - 1.2 gram protein per kg body weight per day.|
|- Primary outcome||Compliance|
|- Secondary outcome||- Nutritional status|
- Body composition
- Hand grip strength
|- Timepoints||Primary outcome: baseline, week 1, week 4, week 8. |
Secundary outcomes: baseline, week 4, week 8.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| HarriŽt Jager-Wittenaar|
|- CONTACT for SCIENTIFIC QUERIES|| HarriŽt Jager-Wittenaar|
|- Sponsor/Initiator ||FrieslandCampina|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||13-okt-2015 - 27-feb-2016|