Hospital Discharge Oral Nutrition Support Trial

October 6, 2015 updated by: Nutricia UK Ltd
To investigate the effect of different strategies for managing malnutrition in the community

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or Female
  • Age 50 years and over
  • Able to eat and drink without the need for altered texture fluids
  • Identified at risk of disease related malnutrition
  • Competent to provide written informed consent
  • Willingness to take part in the study and to follow the study protocol

Exclusion Criteria:

  • Individuals unable to eat or drink
  • Chronic renal disease requiring dialysis
  • Galactosaemia
  • Dysphagia
  • Normally or going to be residing in an institution e.g. care home upon discharge from hospital
  • Palliative care
  • Cancer (active treatment)
  • Liver failure
  • Poorly controlled diabetes
  • Diagnosed lactose intolerance
  • Participation in other clinical trials currently or in the previous 4 weeks
  • Due to be discharged to an area out of the hospital region
  • Requiring tube or parenteral nutrition
  • Due to be discharged from hospital on oral nutrition support recommended by a Dietitian

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ONS 1 and DA
Oral Nutritional Supplement 1 and Dietary Advice
Dietary supplement: Oral Nutritional Supplement 1
Containing macro and micronutrients
Dietary supplement: Dietary Advice
Other: ONS 2 and DA
Oral Nutritional Supplement 2 and Dietary Advice
Dietary supplement: Dietary Advice
Dietary supplement: Oral Nutritional Supplement 2
Containing macro and micronutrients
Other: DA Alone
Dietary Advice Alone
Dietary supplement: Dietary Advice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutrient Intake
Time Frame: 12 weeks (8 week intervention followed by 4 week follow up)
Measured by 3 day diet diaries and 24 hour recall
12 weeks (8 week intervention followed by 4 week follow up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nutricia UK Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

January 17, 2014

First Submitted That Met QC Criteria

January 30, 2014

First Posted (Estimate)

January 31, 2014

Study Record Updates

Last Update Posted (Estimate)

October 7, 2015

Last Update Submitted That Met QC Criteria

October 6, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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