Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/09/2012
Date assigned
03/10/2012
Last edited
09/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of this study is to find out whether energy-dense small-volume oral nutritional supplements (ONS) are more effective than fortified food at helping hospitalized elderly people reach their recommended energy and protein intakes.

Who can participate?
Geriatric inpatients who are undernourished or at risk of undernutrition.

What does the study involve?
Participants are randomly allocated to either receive energy-dense small-volume oral nutritional supplements or fortified foods.

What are the possible benefits and risks of participating?
Possible benefits are increased nutritional intake resulting in improved nutritional, functional and clinical outcomes.

Where is the study run from?
Department of Geriatric Medicine, Medical centre Leeuwarden (Netherlands)

When is study starting and how long is it expected to run for?
November 2009 to May 2010

Who is funding the study?
Nutricia Netherlands BV and Danone Research, Centre for Specialised Nutrition (Netherlands)

Who is the main contact?
Dr DZB van Asselt

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dieneke van Asselt

ORCID ID

Contact details

Department of Geriatric Medicine
Medical Centre Leeuwarden
Postbus 888
Leeuwarden
8901 BR
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effects of oral nutritional supplements compared to fortified foods on energy and protein intake in undernourished geriatric inpatients: a randomised controlled trial

Acronym

Study hypothesis

In between meals, energy dense, small volume oral nutritional supplements (ONS) are more effective than fortified food to reach recommended energy and protein intakes in hospitalized elderly.

Ethics approval

Regional Assessment Patient Research (Regionale Toetsingscommissie Patiengebonden Onderzoek) (RTPO), 12/10/2009, ref: TPO 648

Study design

Parallel two arms randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Malnutrition

Intervention

Intervention group: Energy dense, small volume oral nutritional supplements
Control group: fortified foods

Duration of intervention: during hospitalisation until discharge.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Number of patients achieving an extra intake of 450 kcal per day

Secondary outcome measures

1. Recommended energy and protein intakes
2. Length of hospital stay
3. Antibiotic usage

Overall trial start date

01/11/2009

Overall trial end date

15/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Risk of malnutrition (MNA-sf score 8-11) or malnutrition (MNA-sf score <7)

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

108

Participant exclusion criteria

1. Terminal illness
2. Expected death during hospitalization / palliation
3. Hospital stay shorter than 14 days
4. Incomplete patient files
5. Need for tube feeding
6. A nothing per mouth order

Recruitment start date

01/11/2009

Recruitment end date

15/05/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Medical Centre Leeuwarden
Leeuwarden
8901 BR
Netherlands

Sponsor information

Organisation

Medical Centre Leeuwarden (Netherlands)

Sponsor details

c/o Dieneke van Asselt
Department of Geriatric Medicine
Postbus 888
Leeuwarden
8901 BR
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Nutricia Research Foundation

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Netherlands

Funder name

Danone Research Centre for Specialised Nutrition

Alternative name(s)

Danone Research, Center for Specialised Nutrition, Center for Specialized Nutrition, Centre for Specialised Nutrition of Danone Research

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes