Clinical trial NCT04607330: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Neurological Injury
Respiratory Disease
Stroke
Lead sponsor: Nutricia UK Ltd
Sponsor class: INDUSTRY
First posted: 2020-10-29
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm intervention study to evaluate the acceptability (compliance, gastrointestinal tolerance and palatability) of the high protein liquid feed in patients with elevated protein needs.
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older.
* Patients under the care of a Dietitian requiring oral or enteral nutritional support, with -increased protein needs.
* To receive a minimum of 1 x 40ml HPLM daily (orally or via enteral tube) while on the study.
* Informed consent obtained from the patient

Exclusion Criteria:

* Total parenteral nutrition (100% of requirements).
* Patients with major hepatic dysfunction (i.e. decompensated liver disease).
* Patients with major renal dysfunction (i.e. requiring filtration or Stage 4/5 chronic kidney disease (CKD)).
* Participation in other studies within 1 month prior to entry of this study.
* Patient with severe lactose intolerance.
* Pregnant or lactating.
* Patient lacks capacity to consent for themselves.

Primary outcomes:
measure: Change in Acceptability
timeFrame: 2 days (days 1 and 29)
Secondary outcomes:
measure: Compliance
timeFrame: 29 days
measure: Change in Gastrointestinal tolerance
timeFrame: 4 days (day 1, 8, 15 and 29)
measure: Change in Nutrient Intake (24-hour dietary recall)
timeFrame: 2 days (day 1 and 29)
measure: Change in Physical Function (30-s Chair Stand Test)
timeFrame: 2 days (day 1 and 29)
measure: Change in MUST Screening
timeFrame: 2 days (day 1 and 29)
measure: Change in Height
timeFrame: 2 days (day 1 and 29)
measure: Change in Weight
timeFrame: 2 days (day 1 and 29)
measure: Dietetic Goal
timeFrame: 1 day (day 29)
measure: Adverse events
timeFrame: 29 days (assessed daily)
measure: Patient history
timeFrame: 1 day (day 1)
Other outcomes:
Locations:
city: Worthing
country: United Kingdom
facility: Western Sussex Hospitals NHS Trust
state: West Sussex
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol
Study officials:
affiliation: Nutricia Ltd
name: Rebecca Stratton, PhD
role: STUDY_CHAIR
References: