NCT04607330|Completed
Protein Top-up Acceptability Study for Patients With Increased Protein Needs
Acceptability of a Ready to Use, Low Calorie, Low Volume, High Protein Liquid for Patients With Increased Protein Needs
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Acceptability of a Ready to Use, Low Calorie, Low Volume, High Protein Liquid for Patients With Increased Protein Needs
Sponsor study identifier
interventional
18
1 country
2
Study Start
October 28, 2020
Actual (reported)Primary Completion
May 30, 2022
Actual (reported)Study Completion
June 28, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 28, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 21, 2020
Actual (reported)October 28, 2020
Actual (reported)October 29, 2020
Actual (reported)May 30, 2022
Actual (reported)June 28, 2022
Actual (reported)Change in Acceptability
Acceptability of the patients existing feeding regimen (including any protein module use) will be assessed on day 1, baseline period. Acceptability with the study product will be assessed at the end of the intervention period using a standardised questionnaire completed by the patient.
2 days (days 1 and 29)
Compliance
29 days
Change in Gastrointestinal tolerance
4 days (day 1, 8, 15 and 29)
Change in Nutrient Intake (24-hour dietary recall)
2 days (day 1 and 29)
Change in Physical Function (30-s Chair Stand Test)
2 days (day 1 and 29)
Change in MUST Screening
2 days (day 1 and 29)
A ready to use, low calorie, low volume, ready to use, high protein liquid modular (HPLM) feed for adults.
After a 1-day baseline period to establish patients' acceptability, gastrointestinal tolerance, compliance, dietary intake while also capturing information related to user experience, risk of malnutrition, physical function, dietary intake, anthropometry and safety with their currently prescribed nutritional regimen, each patient will receive the high protein liquid daily for 28 days where the same measures will be replicated. The amount of the high protein liquid prescribed will always be completed by the patients' managing dietitian.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Western Sussex Hospitals NHS Trust
Worthing, West Sussex, BN11 2DH, United Kingdom
University Hospitals Bristol
Bristol, BS2 8HW, United Kingdom
Rebecca Stratton, PhD
Nutricia Ltd
18 participants (actual enrollment reported by the registry).
First Submitted
September 21, 2020
First Posted
October 29, 2020
Study Start
October 28, 2020
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Contact the study team to confirm eligibility.
Primary Completion
May 30, 2022
Actual (reported)Study Completion
June 28, 2022
Actual (reported)Last Updated
April 20, 2023
Record last verified: 2023-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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