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Spots Global Cancer Trial Database for Protein Top-up Acceptability Study for Patients With Increased Protein Needs

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Trial Identification

Brief Title: Protein Top-up Acceptability Study for Patients With Increased Protein Needs

Official Title: Acceptability of a Ready to Use, Low Calorie, Low Volume, High Protein Liquid for Patients With Increased Protein Needs

Study ID: NCT04607330

Interventions

High protein liquid

Study Description

Brief Summary: The aim of this prospective, single-arm intervention study is to evaluate the acceptability (compliance, gastrointestinal tolerance, and palatability) to a low calorie, low volume, ready to use, high protein liquid in patients with elevated protein needs.

Detailed Description: Increased protein needs are frequently observed in disease and can be difficult for patients to achieve where oral food intake is compromised.Where a standard ONS or enteral tube feed cannot meet the needs of patients, a modular feed can be added to the regimen, a low calorie, low volume, ready to use, high protein liquid may help meet protein needs while preventing caloric overfeeding. 40 patients will be recruited in an attempt to evaluate the acceptability (compliance, gastrointestinal tolerance, and palatability) to a low calorie, low volume, ready to use, high protein liquid in patients with elevated protein needs. After a 1-day baseline period to establish patients' acceptability, gastrointestinal tolerance, compliance and dietary intake with their currently prescribed nutritional regimen, each patient will receive the high protein liquid feed daily for 28 days.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Western Sussex Hospitals NHS Trust, Worthing, West Sussex, United Kingdom

University Hospitals Bristol, Bristol, , United Kingdom

Contact Details

Name: Rebecca Stratton, PhD

Affiliation: Nutricia Ltd

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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