Increase Protein Intake in Elderly

Markedly Reduced Food Intake Clinical Trial

Official title:

Increase Protein Intake in Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01907152
• Other study ID #: NL43997.081.13
• Secondary ID: TKI-AF 12065
• Status: Completed
• Phase: N/A
• First received: July 22, 2013
• Last updated: May 15, 2014
• Start date: September 2013
• Est. completion date: January 2014

Study information

• Verified date: May 2014
• Source: Wageningen University and Research Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to investigate the acceptance, intake, and compliance of protein enriched bread and protein enriched yoghurt drinks in elderly patients in two real life settings (short term; hospital, and longer term; rehabilitation home).

Description:

Prevalence rates of protein-energy malnutrition in elderly are high. In order to prevent loss of muscle mass and remain physically independent, it is utmost important for elderly to maintain their body protein mass. A sufficient protein supply according to their needs is therefore highly important. Especially for frail elderly, it is not easy to realize an increased protein intake by simply eating more. It is hypothesized that protein enriched food products that fit in a habitual diet (dairy and bread), result in a higher protein intake compared to regular products.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• admitted to the department of internal medicine of VU university medical center or to the rehabilitation department of "Herstelhotel Dekkerswald"

• signed informed consent

• age of 55 or more

• rehabilitating from a hospital stay with the aim to return back home (rehabilitation home only)

• likely to remain admitted at least 3 weeks (rehabilitation home only).

Exclusion Criteria:

• not speaking Dutch language

• allergy for milk, soy or gluten

• a medical condition that is considered by the treating physician as a contra indication for receiving protein enriched food products

• a diet that does not allow the use of normal bread or dairy products (e.g. fluid diet, strong sodium restricted diet)

• not able to eat or feed themselves

• receiving tube feeding or parenteral nutrition

• suffering from a terminal illness

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Markedly Reduced Food Intake

Intervention

Other:
• Protein enriched yoghurt drink and bread

Locations

Country	Name	City	State
Netherlands	VU university medical center	Amsterdam
Netherlands	Rehabilitation home "Herstelhotel Dekkerswald"	Groesbeek

Sponsors (5)

Lead Sponsor	Collaborator
Wageningen University and Research Centre	Carezzo B.V., Fonterra (Europe) Cooperatie U.A., Hogeschool van Arnhem en Nijmegen (HAN), VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Product evaluation	Questionnaire on appreciation and acceptance of protein enriched food products	3 days (hospital), 3 weeks (rehabilitation home)	No
Primary	Protein intake measured on an individual level over 24h		3 days (hospital), 3 weeks (rehabilitation home)	No
Secondary	Intake of macronutrients (besides protein), total energy, calcium and fibre measured on an individual level over 24h.		3 days (hospital), 3 weeks (rehabilitation home)	No