Hospital Discharge Oral Nutrition Support Trial

Malnutrition Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02051777
• Other study ID #: NCC801
• Status: Completed
• Phase: N/A
• First received: January 17, 2014
• Last updated: October 6, 2015
• Start date: July 2012
• Est. completion date: March 2015

Study information

• Verified date: October 2015
• Source: Nutricia UK Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• Oral Nutritional Supplement 1
Containing macro and micronutrients
• Oral Nutritional Supplement 2
Containing macro and micronutrients
• Dietary Advice

Locations

Country	Name	City	State
United Kingdom	Nutricia Ltd	Bath

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia UK Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutrient Intake	Measured by 3 day diet diaries and 24 hour recall	12 weeks (8 week intervention followed by 4 week follow up)	No