RecruitingNot ApplicableNCT05257980

Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial

Evaluation of Four New Ready to Drink Oral Nutritional Supplements for the Management of Disease-related Malnutrition in Adults.

Sponsor

Nutricia UK Ltd

Enrollment

100 participants

Start Date

Sep 27, 2021

Study Type

INTERVENTIONAL

Conditions

Malnutrition

Summary

The aim of this study is to evaluate compliance, acceptability, gastrointestinal tolerance, nutrient intake, appetite, nutritional status, and safety of four new ready to drink ONS. This is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period. During the intervention period, patients will receive one of the four ONS for 28 days alongside their routine diet.

Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study is testing four new ready-to-drink nutritional supplement drinks to make sure they are acceptable to patients who are malnourished or at risk of malnutrition. Researchers want to know if these drinks are well-tolerated and help people get the nutrition they need. **You may be eligible if...** - You are 16 years or older - You have been identified as malnourished or at risk of malnutrition by a healthcare provider - You are expected to drink at least one supplement bottle per day - You are able to give informed consent **You may NOT be eligible if...** - You are receiving all or most of your nutrition through a feeding tube or intravenous (IV) nutrition - You have severe liver disease - You have severe kidney disease (stage 4 or 5, or on dialysis) - You have certain types of cancer (check with the study team for specifics) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTDietary supplement (ONS)

At baseline, the investigating dietitian/nurse will record several measures, including clinical history and symptoms over the previous 24 hours. In addition, patients who are already receiving an ONS will continue their prescribed ONS for 1 day in which their gastrointestinal tolerance, ONS compliance and acceptability will be recorded. All patients will then receive standardised dietary advice in addition to one of the four trial ONS products daily for 28 days. The type of ONS will be agreed with the patient and the investigating dietitian/nurse, and the ONS prescription will be determined on an individual basis by the investigating dietitian/nurse responsible for the patient's nutritional management (1-3 ONS per day; aligned with guidelines set out within the Malnutrition Pathway). The type of ONS prescribed will be the same throughout the 28 days and will be taken orally.

Locations(19)

Ashford and St Peter's Hospitals NHS Foundation Trust

Ashford, United Kingdom

West Walk Surgery

Bristol, United Kingdom

Rowden Surgery

Chippenham, United Kingdom

Sirona Care & Health

Clevedon, United Kingdom

Mountainhall Treatment Centre

Dumfries, United Kingdom

Royal Surrey NHS Foundation Trust

Guildford, United Kingdom

Preston Hill Surgery

Harrow, United Kingdom

Honiton Surgery

Honiton, United Kingdom

James Alexander Family Practice

Hull, United Kingdom

NHS Highland

Inverness, United Kingdom

Airedale NHS Foundation Trust

Keighley, United Kingdom

Kings Cross Hospital

London, United Kingdom

Northumbria Healthcare NHS Foundation Trust

Newcastle, United Kingdom

Norfolk Community Health and Care NHS Trust

Norwich, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Glan Clwyd Hospital

Rhyl, United Kingdom

Trowbridge Health Centre

Trowbridge, United Kingdom

Cowplain Family Practice

Waterlooville, United Kingdom

Yeovil District Hospital

Yeovil, United Kingdom

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