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OpenTrials
Completed

NCT Number: NCT01907152

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).

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Key information

Conditions

Markedly Reduced Food Intake Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VU university medical center, Amsterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protein enriched yoghurt drink and bread

Other

Primary outcomes

  1. Protein intake measured on an individual level over 24h

    Time frame: 3 days (hospital), 3 weeks (rehabilitation home)

Secondary outcomes

  1. Intake of macronutrients (besides protein), total energy, calcium and fibre measured on an individual level over 24h.

    Time frame: 3 days (hospital), 3 weeks (rehabilitation home)

Other outcomes

  1. Product evaluation

    Time frame: 3 days (hospital), 3 weeks (rehabilitation home)

    Questionnaire on appreciation and acceptance of protein enriched food products

Sponsors and collaborators

Lead sponsor

Wageningen University and Research

Other

Collaborators

  • Amsterdam UMC, location VUmc
  • Carezzo B.V.
  • Fonterra (Europe) Cooperatie U.A.
  • Hogeschool van Arnhem en Nijmegen (HAN)

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jul 24, 2013
Registry last updated
May 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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