Increase Protein Intake in Elderly

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).

Study Overview

• Status: Completed
• Conditions: Markedly Reduced Food Intake
• Intervention / Treatment: Other: Protein enriched yoghurt drink and bread

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • VU University Medical Center
  • Groesbeek, Netherlands
    • Rehabilitation home "Herstelhotel Dekkerswald"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Protein enriched yoghurt drink and bread; Yoghurt drink enriched with Whey Protein Concentrate Whole wheat bread enriched with cereal protein and soy	Other: Protein enriched yoghurt drink and bread
No Intervention: Regular yoghurt drink and bread; Commercially available yoghurt drink and whole wheat bread

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Protein intake measured on an individual level over 24h	3 days (hospital), 3 weeks (rehabilitation home)

Secondary Outcome Measures

Outcome Measure	Time Frame
Intake of macronutrients (besides protein), total energy, calcium and fibre measured on an individual level over 24h.	3 days (hospital), 3 weeks (rehabilitation home)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Product evaluation	Questionnaire on appreciation and acceptance of protein enriched food products	3 days (hospital), 3 weeks (rehabilitation home)

Collaborators and Investigators

• Sponsor: Wageningen University and Research
• Collaborators: Amsterdam UMC, location VUmc; Fonterra (Europe) Cooperatie U.A.; Carezzo B.V.; Hogeschool van Arnhem en Nijmegen (HAN)
• Investigators: Principal Investigator: Esther Boelsma, PhD, Wageningen UR Food and Biobased Research

Publications and helpful links

General Publications

• Stelten S, Dekker IM, Ronday EM, Thijs A, Boelsma E, Peppelenbos HW, de van der Schueren MA. Protein-enriched 'regular products' and their effect on protein intake in acute hospitalized older adults; a randomized controlled trial. Clin Nutr. 2015 Jun;34(3):409-14. doi: 10.1016/j.clnu.2014.08.007. Epub 2014 Aug 15.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: July 22, 2013
• First Submitted That Met QC Criteria: July 22, 2013
• First Posted (Estimate): July 24, 2013

Study Record Updates

• Last Update Posted (Estimate): May 16, 2014
• Last Update Submitted That Met QC Criteria: May 15, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: malnutrition; undernourishment; loss of muscle mass
• Other Study ID Numbers: NL43997.081.13; TKI-AF 12065 (Other Grant/Funding Number: Stichting Topconsortium voor Kennis en Innovatie Agri & Food)