Malnutrition
Conditions
Keywords
Nutrition, COPD
Brief summary
The purpose of this study is to determine the best form of dietary intervention to undernourished individuals with COPD. The research aims to test the null hypothesis that there is no difference between oral nutritional supplements and dietary advice.
Interventions
DIETARY_SUPPLEMENTOral Nutritional Supplements (Fortisip)
These products are classified as non-medicinal, borderline substances, foods for special medical purposes. A range of commercially available liquid oral nutritional supplements (Fortisip) will be offered daily for a 3 month period.
OTHERDietary Advice
Standard dietary advice
Sponsors
University Hospital Southampton NHS Foundation Trust
University of Southampton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female * Age \>18 years * At risk of malnutrition * Competent to provide written informed consent and able to answer questions * Able to eat and drink * Willingness to take part in the trial and to follow the trial protocol * FEV1 \<80% predicted and FEV1/FVC \<0.7
Exclusion criteria
* Requirement for tube or parenteral nutrition * Galactosemia * Receiving current oral nutritional supplementation * Palliative care * Chronic renal disease requiring dialysis * Liver failure * Malignancy * Participation in other studies * Bronchiectasis * Those already under the care of a dietitian
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is Quality of Life | 6 months |
Countries
United Kingdom
Outcome results
None listed