Community Oral Nutrition Support Trial | Completed
Community Oral Nutrition Support Tr... | Completed
Community Oral Nutrition Support Trial

Trial Source

Location not identified by Google services

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Medical Conditions
  • Malnutrition
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT00515125
Primary Trial ID Number

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
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.
Research Details
  • 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.
Phase
N/A
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Behavioral : Dietary Advice, Dietary Supplement : Oral Nutritional Supplements (Fortisip)

Study Arm Groups : Dietary Advice, Oral Nutritional Supplements

Intervention Type
See Interventions above
Primary Outcome Measures
    The primary outcome measure is Quality of Life; 6 months
Secondary Outcome Measures
    Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
50 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Brook Lane Surgery
Southampton
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Nutrition in the Community.
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
ELIA0001
Sponsor(s)
University of Southampton
Key Dates

Recruitment Start Date

Aug 2007

Recruitment End Date

Mar 2010

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

10 Aug 2007

Date updated in source

10 Sep 2015