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

June 4, 2014 updated by: Wageningen University

Can Protein Intake be Increased by Offering Protein-enriched Foods and Drinks? Evaluation of a Pilot in a Local Residential Care Home.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Wageningen, Gelderland, Netherlands, 6702 BR
        • Nudehof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Protein enriched products
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
Newly developed products with extra protein. Specially developed for elderly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in protein intake
Time Frame: baseline, day 9 and 10 of intervention
baseline, day 9 and 10 of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with newly developed products
Time Frame: all days of intervention participants will be followed, an average of 10 days
Qualitative measurement
all days of intervention participants will be followed, an average of 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wageningen University

Investigators

  • Principal Investigator: N M de Roos, PhD, Wageningen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 29, 2013

First Submitted That Met QC Criteria

May 16, 2014

First Posted (Estimate)

May 19, 2014

Study Record Updates

Last Update Posted (Estimate)

June 5, 2014

Last Update Submitted That Met QC Criteria

June 4, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL45883.081.13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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