Hospital Discharge Oral Nutrition Support Trial

NCT ID: NCT02051777

Last Updated: 2015-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-03-31

Brief Summary

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To investigate the effect of different strategies for managing malnutrition in the community

Detailed Description

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Conditions

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Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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ONS 1 and DA

Oral Nutritional Supplement 1 and Dietary Advice

Group Type OTHER

Oral Nutritional Supplement 1

Intervention Type DIETARY_SUPPLEMENT

Containing macro and micronutrients

Dietary Advice

Intervention Type DIETARY_SUPPLEMENT

ONS 2 and DA

Oral Nutritional Supplement 2 and Dietary Advice

Group Type OTHER

Oral Nutritional Supplement 2

Intervention Type DIETARY_SUPPLEMENT

Containing macro and micronutrients

Dietary Advice

Intervention Type DIETARY_SUPPLEMENT

DA Alone

Dietary Advice Alone

Group Type OTHER

Dietary Advice

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Oral Nutritional Supplement 1

Containing macro and micronutrients

Intervention Type DIETARY_SUPPLEMENT

Oral Nutritional Supplement 2

Containing macro and micronutrients

Intervention Type DIETARY_SUPPLEMENT

Dietary Advice

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nutricia UK Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nutricia Ltd

Bath, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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NCC801

Identifier Type: -

Identifier Source: org_study_id

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