NCT02141256

Brief Summary

The objective of this study is to investigate whether a protein-enriched daily menu is acceptable and effective in increasing protein intake in elderly in a residential care home up to an intake of 1,2 gram/ kg body weight per day. The investigators hypothesise that when elderly eat 2 slices of bread, 1 portion of juice and 1 portion of soup each day, the protein intake can be increased by at least 20 grams/day. On average this can lead to an intake of 1,2 gram/ kg body weight per day.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2013

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 19, 2014

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 5, 2014

Status Verified

June 1, 2014

Enrollment Period

8 months

First QC Date

October 29, 2013

Last Update Submit

June 4, 2014

Conditions

Undernutrition

Keywords

elderlyprotein enrichmentundernutrition

Outcome Measures

Primary Outcomes (1)

  • Change in protein intake

    baseline, day 9 and 10 of intervention

Secondary Outcomes (1)

  • Satisfaction with newly developed products

    all days of intervention participants will be followed, an average of 10 days

Study Arms (1)

Protein enriched products

EXPERIMENTAL

Protein enriched products will be given to elderly residents of a care home for 10 days. Does this lead to an increased protein intake or do elderly compensate for the extra amount of protein?

Dietary Supplement: Protein enriched products

Interventions

Protein enriched productsDIETARY_SUPPLEMENT

Newly developed products with extra protein. Specially developed for elderly.

Protein enriched products

Eligibility Criteria

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

You may qualify if:

  • Aged 65 or older
  • living in care home Nudehof
  • able to give consent
  • without dietary protein restrictions

You may not qualify if:

  • cognitive impaired
  • having dementia
  • having dysphagia
  • receiving only tube feeding
  • known kidney disease
  • having food allergies that exclude them from having the protein-enriched products
  • following a low protein diet or a diet low in sodium
  • receiving palliative care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nudehof

Wageningen, Gelderland, 6702 BR, Netherlands

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • N M de Roos, PhD

    Wageningen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2013

First Posted

May 19, 2014

Study Start

October 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 5, 2014

Record last verified: 2014-06

Locations

NL(1)