Condition category
Nutritional, Metabolic, Endocrine
Date applied
07/07/2005
Date assigned
21/10/2005
Last edited
04/03/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marion McMurdo

ORCID ID

Contact details

Ageing and Health
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CZH/4/283

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Undernourished older people admitted with an acute illness

Intervention

Complete liquid protein and energy supplement (400 ml/day) or matching liquid placebo with minimal protein and energy content over a 12 week period.

Intervention type

Supplement

Phase

Not Specified

Drug names

Nutritional supplementation

Primary outcome measures

1. Changes in muscle strength (handgrip dynamometry)
2. Changes in disability (Barthel index)

Secondary outcome measures

1. Changes in lower limb muscle strength
2. Changes in weight
3. Changes in dietary intake (24 hour dietary recall)
4. Changes in daily physical activity levels (accelerometry)
5. Changes in health related quality of life (Euroquol)
6. Unplanned hospital readmissions

Overall trial start date

01/02/2006

Overall trial end date

30/07/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 70 years and over
2. Community dwelling
3. Admitted to hospital with an acute illness
4. Body mass index ≤24 kg/m^2
5. Mid-arm muscle circumference below the 10th centile and/or weight loss of 5% or more during hospital stay

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

320

Participant exclusion criteria

1. Chronic liver diease or renal failure
2. Nursing home residents
3. Cognitive impairment precluding informed consent
4. Dysphagia
5. Metastatic carcinoma or other terminal illness
6. Pathology such as inflammatory arthritis or stroke affecting non-dominant handgrip
7. Major surgery within one month

Recruitment start date

01/02/2006

Recruitment end date

30/07/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ageing and Health
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee (UK)

Sponsor details

Research & Innovation Services
University of Dundee
Dundee
DD1 9SY
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Chief Scientist Office, Scottish Executive (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19925613

Publication citations

  1. Results

    McMurdo ME, Price RJ, Shields M, Potter J, Stott DJ, Should oral nutritional supplementation be given to undernourished older people upon hospital discharge? A controlled trial., J Am Geriatr Soc, 2009, 57, 12, 2239-2245, doi: 10.1111/j.1532-5415.2009.02568.x.

Additional files

Editorial Notes