Clinical trial NCT02213393: Cater With Care Effect Study
Official title: Effectiveness of Cater With Care Products in Reaching Recommendations for Protein Intake During and After Hospital Stay and in Improving Functional Status After Hospital Stay in Elderly Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Undernutrition
Keywords: undernutrition
nutritional status
elderly patients
protein
enriched products
recovery
physical function
quality of life
activities of daily living
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2014-08-11
Enrollment: 162
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is 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 body weight/day and in improving functional status after hospital stay in elderly patients.

Detailed description: Rationale: About 25% of hospitalized elderly patients are at risk of undernutrition at admission. Many hospitals provide an energy and protein enriched diet, extra snacks, and oral nutritional supplements if needed. Still, a considerable part of these patients are unable to meet protein requirements and are still at risk of undernutrition at hospital discharge. This may impair recovery of illness, partly due to loss of muscle mass and physical performance. To improve protein intake, Cater with Care products have been developed: a selection of foods and drinks that are consumed often by elderly persons, but now enriched with protein up to 10 grams per portion. We hypothesize that these products help to reach protein requirements in elderly patients during and after hospital stay and thereby improve their health outcomes.

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.

Eligibility criteria: Inclusion Criteria:

* Hospital phase:
* 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:

* Hospital phase:
* 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

Primary outcomes:
measure: Change from Baseline Protein intake and Physical functioning at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change in muscle strength from baseline to 6 months.
timeFrame: 6 months
measure: Change in nutritional status from baseline to 6 months.
timeFrame: 6 months
measure: Change in Quality of Life from baseline to 6 months.
timeFrame: 6 months.
measure: Change in Activities of Daily Living from baseline to 6 months.
timeFrame: 6 months
Other outcomes:
measure: BMI
timeFrame: 6 months
measure: Physical Activity
timeFrame: 6 months
measure: Length of hospital stay
timeFrame: 12 weeks
measure: Costs of hospital stay
timeFrame: 12 weeks
Locations:
city: Ede
country: Netherlands
facility: Hospital Gelderse Vallei
state: Gelderland
Study officials:
affiliation: Wageningen University
name: Nicole M de Roos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.