Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
162 participants
INTERVENTIONAL
2014-10-31
2015-10-31
Brief Summary
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Detailed Description
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Objective: To study the effectiveness of supplementing a standard hospital and 12-week home menu with protein-enriched Cater with Care products in reaching a protein intake of 1,2-1,5 g/kg/day and in improving functional status after hospital stay in elderly patients.
Study design: Randomised Controlled Trial (RCT) with 2 intervention groups and two phases: a hospital phase including all admitted patients and a home phase with a selection of patients.
Study population: Patients of 65 years or over who are admitted to the departments of Geriatrics, Pulmonary Disease, or Internal Medicine of Hospital Gelderse Vallei.
Intervention: The control group receives the standard hospital menu for elderly at risk of undernutrition (energy and protein rich) and a variety of foods and drinks to be used as part of their home diet for 12 weeks after hospitalization. Foods and drinks for home use are non-enriched variants of Cater with Care products (e.g. normal fruit juice).
The intervention group receives Cater with Care protein-enriched foods and drinks during hospital stay (in addition to the standard hospital menu) and at home as part of their home diet for 12 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Protein enriched products
The intervention group receives protein enriched products (CwC products) in the hospital and receives these also after discharge during 12 weeks.
Protein enriched products
The intervention group receives CwC protein enriched products. After discharge the intervention group receives CwC products delivered at home for 12 weeks.
Usual menu
The control group receives the usual protein and energy rich menu in the hospital and receives regular products, no protein enrichment, after discharge during 12 weeks.
Usual menu
The control group receives the usual menu, which is energy and protein rich in this elderly patient group. After discharge the control group receives regular products, no protein enrichment, at home for 12 weeks.
Interventions
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Protein enriched products
The intervention group receives CwC protein enriched products. After discharge the intervention group receives CwC products delivered at home for 12 weeks.
Usual menu
The control group receives the usual menu, which is energy and protein rich in this elderly patient group. After discharge the control group receives regular products, no protein enrichment, at home for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* admitted to the wards of Geriatric medicine, Pulmonary Medicine, or Internal Medicine in Hospital Gelderse Vallei
* aged 65 years or over
* being eligible for receiving a standard protein enriched menu based on hospital protocol
* Home phase:
* included in the hospital phase of the study
* consent to continue treatment and study participation after hospital discharge
Exclusion Criteria
* unwilling to give consent for gathering data from the medical record or meal service system
* unable to understand Dutch
* food allergies, food intolerances or other dietary restrictions that prevents the patient from receiving the standard protein enriched menu or Cater with Care products based on the judgement of a dietician and/or medical staff
* expected length of hospital stay less than 4 days
* renal insufficiency (eGFR \< 30 ml/min)
* starting with tube feeding or total parenteral nutrition within 2 days of admission
* refeeding syndrome score \> 0 based on hospital screening tool for refeeding risk
* delirium at admission
* receiving palliative care
* Home phase:
* going to a nursing home, rehabilitation centre or hospice after hospital discharge
* cognitive impairment or diagnosed with dementia
* legally incapacitated
65 Years
ALL
No
Sponsors
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Wageningen University
OTHER
Responsible Party
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Principal Investigators
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Nicole M de Roos, PhD
Role: PRINCIPAL_INVESTIGATOR
Wageningen University
Locations
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Hospital Gelderse Vallei
Ede, Gelderland, Netherlands
Countries
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References
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Beelen J, Vasse E, Janssen N, Janse A, de Roos NM, de Groot LCPGM. Protein-enriched familiar foods and drinks improve protein intake of hospitalized older patients: A randomized controlled trial. Clin Nutr. 2018 Aug;37(4):1186-1192. doi: 10.1016/j.clnu.2017.05.010. Epub 2017 May 18.
Other Identifiers
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NL48893.081.14
Identifier Type: -
Identifier Source: org_study_id
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