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Chronic Obstructive Pulmonary Disease (COPD) Nutrition Support Trial

This study has been completed.
University Hospital Southampton NHS Foundation Trust
Information provided by (Responsible Party):
University of Southampton Identifier:
First received: September 4, 2007
Last updated: December 5, 2014
Last verified: December 2014

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.

Condition Intervention
Malnutrition Dietary Supplement: Oral Nutritional Supplements (Fortisip) Other: Dietary Advice

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Outcomes in Patients With COPD

Resource links provided by NLM:

Further study details as provided by University of Southampton:

Primary Outcome Measures:
  • The primary outcome measure is Quality of Life [ Time Frame: 6 months ]

Enrollment: 85
Study Start Date: January 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Dietary Advice
Other: Dietary Advice
Standard dietary advice
Dietary Supplement: Oral 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.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00538200

United Kingdom
Southampton University Hospitals NHS Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
Sponsors and Collaborators
University of Southampton
University Hospital Southampton NHS Foundation Trust
Principal Investigator: Marinos Elia, Professor University of Southampton
  More Information

Responsible Party: University of Southampton Identifier: NCT00538200     History of Changes
Other Study ID Numbers: ELIA002
Study First Received: September 4, 2007
Last Updated: December 5, 2014

Keywords provided by University of Southampton:

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Nutrition Disorders processed this record on September 25, 2017