Pilot study to investigate dietary supplementation of elderly COPD patients with an oral nutritional supplement enriched with n-3 polyunsaturated fatty acids and its effect on respiratory function, appetite and weight

ISRCTN	ISRCTN16343749
DOI	https://doi.org/10.1186/ISRCTN16343749
Protocol serial number	N0016148139
Sponsor	Department of Health
Funders	Hammersmith Hospital NHS Trust (UK), Hammersmith Hospital Trustees Research Committee (HHTRC) (UK)

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 10/05/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Gary Frost
Scientific

Nutrition & Dietetics Department
2nd Floor, C Block
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Phone	+44 (0)20 8383 3048(bleep 9027)
Email	g.frost@imperial.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Pilot study to investigate dietary supplementation of elderly COPD patients with an oral nutritional supplement enriched with n-3 polyunsaturated fatty acids and its effect on respiratory function, appetite and weight
Study objectives	Does the addition of fish oil to a complete nutritional supplement make supplementation more effective? i.e. do patients gain more weight, improve their lung function and exercise tolerance and report improved appetite when compared to patients using supplements without fish oils?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Chronic obstructive pulmonary disease (COPD)
Intervention	Randomised controlled trial
Intervention type	Other
Primary outcome measure(s)	1. Improved lung function 2. Decreased sytokine responses. Fish oils have been used with promising results in other wasting conditions such as HIV, cancer and sepsis. There are no published trials investigating the possible benefits of fish oil supplementation in COPD patients and this proposal aims to do this.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/07/2003

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Not Specified
Key inclusion criteria	Out patients from COPD clinic at the Hammersmith Hospitals NHS Trust
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/07/2002
Date of final enrolment	01/07/2003

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Nutrition & Dietetics Department

London
W12 0HS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

10/05/2018: No publications found, verifying study status with principal investigator.
01/03/2016: No publications found, verifying study status with principal investigator.