Hospital Discharge Oral Nutrition Support Trial

Not Applicable

Completed

• Conditions: Malnutrition
• Interventions: Dietary Supplement: Oral Nutritional Supplement 2; Dietary Supplement: Oral Nutritional Supplement 1; Dietary Supplement: Dietary Advice

• Registration Number: NCT02051777
• Lead Sponsor: Nutricia UK Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2014-01-17
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-01-31
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-06
• Last Update Posted: 2015-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ONS 1 and DA	Dietary Advice	Oral Nutritional Supplement 1 and Dietary Advice
ONS 2 and DA	Oral Nutritional Supplement 2	Oral Nutritional Supplement 2 and Dietary Advice
ONS 1 and DA	Oral Nutritional Supplement 1	Oral Nutritional Supplement 1 and Dietary Advice
DA Alone	Dietary Advice	Dietary Advice Alone
ONS 2 and DA	Dietary Advice	Oral Nutritional Supplement 2 and Dietary Advice

Primary Outcome Measures

Name	Time	Method
Nutrient Intake	12 weeks (8 week intervention followed by 4 week follow up)	Measured by 3 day diet diaries and 24 hour recall

Trial Locations

Locations (1)

Nutricia Ltd; 🇬🇧 Bath, United Kingdom