NCT02213393

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 13, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

August 7, 2014

Last Update Submit

November 11, 2015

Conditions

Undernutrition

Keywords

undernutritionnutritional statuselderly patientsproteinenriched productsrecoveryphysical functionquality of lifeactivities of daily living

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Protein intake and Physical functioning at 6 months

    This study has 2 primary outcomes: protein intake and physical functioning. These will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.

    6 months

Secondary Outcomes (4)

  • Change in muscle strength from baseline to 6 months.

    6 months

  • Change in nutritional status from baseline to 6 months.

    6 months

  • Change in Quality of Life from baseline to 6 months.

    6 months.

  • Change in Activities of Daily Living from baseline to 6 months.

    6 months

Other Outcomes (4)

  • BMI

    6 months

  • Physical Activity

    6 months

  • Length of hospital stay

    12 weeks

  • +1 more other outcomes

Study Arms (2)

Protein enriched products

EXPERIMENTAL

The intervention group receives protein enriched products (CwC products) in the hospital and receives these also after discharge during 12 weeks.

Dietary Supplement: Protein enriched products

Usual menu

ACTIVE COMPARATOR

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.

Dietary Supplement: Usual menu

Interventions

Protein enriched productsDIETARY_SUPPLEMENT

The intervention group receives CwC protein enriched products. After discharge the intervention group receives CwC products delivered at home for 12 weeks.

Also known as: CwC products
Protein enriched products
Usual menuDIETARY_SUPPLEMENT

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.

Usual menu

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Gelderse Vallei

Ede, Gelderland, 6716 RP, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 28571713DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Nicole M de Roos, PhD

    Wageningen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2014

First Posted

August 11, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

November 13, 2015

Record last verified: 2015-11

Locations

NL(1)