Oral nutritional supplements and dietary advice versus dietary advice alone on clinical outcomes in malnourished community dwelling individuals

Not Applicable

Completed

• Conditions: Malnutrition in the elderly; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN26004104
• Lead Sponsor: Southampton University Hospitals NHS Trust (UK)

Brief Summary

1. 2017 results presented at ESPEN 2017: https://doi.org/10.1016/S0261-5614(17)30769-0 2. 2017 results presented at ESPEN 2017: https://doi.org/10.1016/S0261-5614(17)30635-0 3. 2018 results presented at ESPEN 2018: https://doi.org/10.1016/j.clnu.2018.06.1366 4. 2018 results presented at ESPEN 2018: https://doi.org/10.1016/j.clnu.2017.02.008

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-05
• Study Completion: 2016-09-01
• Last Update Posted: 18 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Male or female
2. Age > 50 years
3. Disease-related malnutrition using Malnutrition Universal Screening Tool (MUST)
4. Malnutrition caused by disease/clinical condition
5. Competent to provide written informed consent and able to answer questions
6. Able to eat and drink
7. Willingness to take part in the trial and to follow the trial protocol

Exclusion Criteria

1. Galactosemia or known lactose intolerance
2. Currently receiving (or likely to receive in next 12 weeks) nutritional support including dietary advice, oral nutritional supplements, tube or parenteral nutrition
3. Chronic renal disease requiring dialysis
4. Dysphagia
5. Poorly controlled diabetes
6. Liver failure
7. Cancer
8. Palliative / end of life care
9. Active malignancy / active cancer treatment / palliative care
10. Malnutrition as a result of social factors e.g. unable to purchase food
11. Currently residing in an institution to receive care e.g. care home
12. Participation in other clinical trials

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of Life (QOL) at baseline (BL), wk 4,8,12, 6 months and optional 12 months

Secondary Outcome Measures

Name	Time	Method
<br> 1. Acceptability and complicance at BL, weeks 4, 8, 12<br> 2. Clinical / Functional at BL, weeks 4, 8, 12, 6 months and optional 12 months<br> 3. Intake at BL, weeks 4,8,12, 6 months and optional 12 months<br> 4. Resource Use at BL, weeks 4, 8, 12, 6 months, optional 12 months<br> 5. Weight at BL, weeks 4, 8, 12, 6 months and optional 12 months<br>