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Can Protein Intake be Increased by Offering Protein-enriched Foods and Drinks? (EET-studie)

Primary Purpose

Undernutrition

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Protein enriched products
Sponsored by
Wageningen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Undernutrition focused on measuring elderly, protein enrichment, undernutrition

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Nudehof

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Protein enriched products

Arm Description

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?

Outcomes

Primary Outcome Measures

Change in protein intake

Secondary Outcome Measures

Satisfaction with newly developed products
Qualitative measurement

Full Information

First Posted
October 29, 2013
Last Updated
June 4, 2014
Sponsor
Wageningen University
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1. Study Identification

Unique Protocol Identification Number
NCT02141256
Brief Title
Can Protein Intake be Increased by Offering Protein-enriched Foods and Drinks?
Acronym
EET-studie
Official Title
Can Protein Intake be Increased by Offering Protein-enriched Foods and Drinks? Evaluation of a Pilot in a Local Residential Care Home.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wageningen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Rationale: Due to inactivity, elderly are prone to lose muscle mass. With an increased protein intake, muscle mass might be maintained. The current recommendation for protein intake for elderly is the same as for younger adults, but researchers and geriatricians appeal for a higher recommended protein intake to maintain health and function. One way to reach a higher intake is by providing protein-enriched foods. Because of concerns that these foods are more satiating, careful monitoring of protein intake after introducing these foods is warranted. Objective: 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. Study design: Dietary intake will be monitored before and after introducing a protein-enriched daily menu. The menu will be provided for 10 days to all residents of the care home. For residents who give consent, intake will be recorded by trained research assistants and nurses on 2 consecutive days before the pilot and on days 9 and 10 of the pilot. After the pilot residents will return to their regular menus. Study population: The study population consists of elderly men and women (aged 65 or older) living in a care home in Wageningen, the Netherlands. Intervention: A protein-enriched daily menu for 10 days. Main study parameters/endpoints: Protein intake and resident satisfaction with the menu.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Undernutrition
Keywords
elderly, protein enrichment, undernutrition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protein enriched products
Arm Type
Experimental
Arm Description
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?
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein enriched products
Intervention Description
Newly developed products with extra protein. Specially developed for elderly.
Primary Outcome Measure Information:
Title
Change in protein intake
Time Frame
baseline, day 9 and 10 of intervention
Secondary Outcome Measure Information:
Title
Satisfaction with newly developed products
Description
Qualitative measurement
Time Frame
all days of intervention participants will be followed, an average of 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 65 or older living in care home Nudehof able to give consent without dietary protein restrictions Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
N M de Roos, PhD
Organizational Affiliation
Wageningen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nudehof
City
Wageningen
State/Province
Gelderland
ZIP/Postal Code
6702 BR
Country
Netherlands

12. IPD Sharing Statement

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Can Protein Intake be Increased by Offering Protein-enriched Foods and Drinks?

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