Clinical trial · Interventional
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
NCT04607330CI-TRIAL-00065840completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Neurological Injury | — | UNRESOLVED | — |
| Respiratory Disease | — | UNRESOLVED | — |
| Stroke | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High protein liquid | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High protein liquid
- description
- A ready to use, low calorie, low volume, ready to use, high protein liquid modular (HPLM) feed for adults.
- interventionNames
- Other: High protein liquid
Primary outcomes (1)
- measure
- Change in Acceptability
- timeFrame
- 2 days (days 1 and 29)
- description
- 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.
Secondary outcomes (10)
- measure
- Compliance
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.