NCT01907152

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

May 16, 2014

Status Verified

May 1, 2014

Enrollment Period

3 months

First QC Date

July 22, 2013

Last Update Submit

May 15, 2014

Conditions

Markedly Reduced Food Intake

Keywords

malnutritionundernourishmentloss of muscle mass

Outcome Measures

Primary Outcomes (1)

  • Protein intake measured on an individual level over 24h

    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.

    3 days (hospital), 3 weeks (rehabilitation home)

Other Outcomes (1)

  • Product evaluation

    3 days (hospital), 3 weeks (rehabilitation home)

Study Arms (2)

Protein enriched yoghurt drink and bread

EXPERIMENTAL

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

Other: Protein enriched yoghurt drink and bread

Regular yoghurt drink and bread

NO INTERVENTION

Commercially available yoghurt drink and whole wheat bread

Interventions

Protein enriched yoghurt drink and breadOTHER
Protein enriched yoghurt drink and bread

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VU university medical center

Amsterdam, Netherlands

Location

Rehabilitation home "Herstelhotel Dekkerswald"

Groesbeek, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 25179468DERIVED

MeSH Terms

Conditions

Malnutrition

Interventions

Bread

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Esther Boelsma, PhD

    Wageningen UR Food and Biobased Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2013

First Posted

July 24, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

May 16, 2014

Record last verified: 2014-05

Locations

NL(2)