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

NCT ID: NCT02141256

Last Updated: 2014-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-06-30

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.

Conditions

Undernutrition

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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?

Group Type: EXPERIMENTAL

Protein enriched products

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Protein enriched products

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wageningen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

N M de Roos, PhD

Role: PRINCIPAL_INVESTIGATOR

Wageningen University

Locations

Nudehof

Wageningen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

NL45883.081.13

Identifier Type: -

Identifier Source: org_study_id