Clinical trial NCT01907152: Increase Protein Intake in Elderly
Official title: Increase Protein Intake in Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Markedly Reduced Food Intake
Keywords: malnutrition
undernourishment
loss of muscle mass
Lead sponsor: Wageningen University and Research
Sponsor class: OTHER
Collaborators: name: Fonterra (Europe) Cooperatie U.A.
name: Carezzo B.V.
name: Amsterdam UMC, location VUmc
name: Hogeschool van Arnhem en Nijmegen (HAN)
First posted: 2013-07-24
Enrollment: 106
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to investigate the acceptance, intake, and compliance of protein enriched bread and protein enriched yoghurt drinks in elderly patients in two real life settings (short term; hospital, and longer term; rehabilitation home).

Detailed description: Prevalence rates of protein-energy malnutrition in elderly are high. In order to prevent loss of muscle mass and remain physically independent, it is utmost important for elderly to maintain their body protein mass. A sufficient protein supply according to their needs is therefore highly important. Especially for frail elderly, it is not easy to realize an increased protein intake by simply eating more. It is hypothesized that protein enriched food products that fit in a habitual diet (dairy and bread), result in a higher protein intake compared to regular products.

Eligibility criteria: Inclusion Criteria:

* admitted to the department of internal medicine of VU university medical center or to the rehabilitation department of "Herstelhotel Dekkerswald"
* signed informed consent
* age of 55 or more
* rehabilitating from a hospital stay with the aim to return back home (rehabilitation home only)
* likely to remain admitted at least 3 weeks (rehabilitation home only).

Exclusion Criteria:

* not speaking Dutch language
* allergy for milk, soy or gluten
* a medical condition that is considered by the treating physician as a contra indication for receiving protein enriched food products
* a diet that does not allow the use of normal bread or dairy products (e.g. fluid diet, strong sodium restricted diet)
* not able to eat or feed themselves
* receiving tube feeding or parenteral nutrition
* suffering from a terminal illness

Primary outcomes:
measure: Protein intake measured on an individual level over 24h
timeFrame: 3 days (hospital), 3 weeks (rehabilitation home)
Secondary outcomes:
measure: Intake of macronutrients (besides protein), total energy, calcium and fibre measured on an individual level over 24h.
timeFrame: 3 days (hospital), 3 weeks (rehabilitation home)
Other outcomes:
measure: Product evaluation
timeFrame: 3 days (hospital), 3 weeks (rehabilitation home)
Locations:
city: Amsterdam
country: Netherlands
facility: VU university medical center
city: Groesbeek
country: Netherlands
facility: Rehabilitation home "Herstelhotel Dekkerswald"
Study officials:
affiliation: Wageningen UR Food and Biobased Research
name: Esther Boelsma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stelten S, Dekker IM, Ronday EM, Thijs A, Boelsma E, Peppelenbos HW, de van der Schueren MA. Protein-enriched 'regular products' and their effect on protein intake in acute hospitalized older adults; a randomized controlled trial. Clin Nutr. 2015 Jun;34(3):409-14. doi: 10.1016/j.clnu.2014.08.007. Epub 2014 Aug 15.