Increase Protein Intake in Elderly

NCT ID: NCT01907152

Last Updated: 2014-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-01-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Markedly Reduced Food Intake

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Protein enriched yoghurt drink and bread

Yoghurt drink enriched with Whey Protein Concentrate Whole wheat bread enriched with cereal protein and soy

Group Type EXPERIMENTAL

Protein enriched yoghurt drink and bread

Intervention Type OTHER

Regular yoghurt drink and bread

Commercially available yoghurt drink and whole wheat bread

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Protein enriched yoghurt drink and bread

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fonterra (Europe) Cooperatie U.A.

UNKNOWN

Sponsor Role collaborator

Carezzo B.V.

OTHER

Sponsor Role collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role collaborator

Hogeschool van Arnhem en Nijmegen (HAN)

UNKNOWN

Sponsor Role collaborator

Wageningen University and Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Esther Boelsma, PhD

Role: PRINCIPAL_INVESTIGATOR

Wageningen UR Food and Biobased Research

Locations

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VU university medical center

Amsterdam, , Netherlands

Site Status

Rehabilitation home "Herstelhotel Dekkerswald"

Groesbeek, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 25179468 (View on PubMed)

Other Identifiers

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TKI-AF 12065

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NL43997.081.13

Identifier Type: -

Identifier Source: org_study_id

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