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Community Oral Nutrition Support Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Southampton
ClinicalTrials.gov Identifier:
NCT00515125
First received: August 10, 2007
Last updated: September 10, 2015
Last verified: June 2015
  Purpose

The purpose of this study is to determine the best form of dietary intervention to undernourished elderly individuals in care homes.

The research aims to test the null hypothesis that there is no difference between oral nutritional supplements and dietary advice as the first line treatment for malnutrition.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Nutrition in the Community.

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 ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: August 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Dietary Advice
Dietary Advice
Behavioral: Dietary Advice
Dietary Advice sheet
Oral Nutritional Supplements
Oral Nutritional Supplements
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 12 week period.


Detailed Description:
A prospective, randomised, parallel, open-label trial, study in malnourished care home residents, without obvious dementia, to compare the effects of two common forms of nutritional support; dietary advice (DA) and oral nutritional supplements (ONS), on quality of life (QoL) and other outcomes including weight, nutritional intake and appetite. The residents were randomised to receive either DA provided by a dietitian or ONS for a period of 12 weeks. The primary outcome measure was QoL and the secondary outcome measure was dietary intake.
  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female
  • Age > 50 years
  • At risk of malnutrition
  • Competent to provide written informed consent and to answer questions
  • Able to eat and drink
  • Willingness to take part in the trial and to follow the trial protocol

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
  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 ClinicalTrials.gov identifier: NCT00515125

Locations
United Kingdom
Care Homes in Hampshire
Southampton, Hampshire, United Kingdom
Sponsors and Collaborators
University of Southampton
Investigators
Principal Investigator: Marinos Elia, Professor University of Southampton
  More Information

Responsible Party: University of Southampton
ClinicalTrials.gov Identifier: NCT00515125     History of Changes
Other Study ID Numbers: ELIA0001 
Study First Received: August 10, 2007
Last Updated: September 10, 2015
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Southampton:
Quality of life
Supplement
Care home
Elderly
Malnutrition

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on December 02, 2016