NCT05411848Completed
2kcal Tube Feed Study
Evaluation of a Nutritionally Complete, Plant-based, High Energy, High Protein, Enteral Tube Feed in Adults
Source: ClinicalTrials.gov · Last updated 26 Feb 2025
Brief summary (registry, in English)
The primary aim of this study is to investigate the effects of a plant-based, high energy, high protein tube feed with and without inclusion of fibre on gastrointestinal tolerance in adult patients who require nutritional support via enteral tube feeding over a 28-day period, followed by a 12-month follow-up. Secondary aims are to determine the effects on compliance, acceptability, anthropometry, nutrient intake, and physical function. This is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period and a 1-year follow-up.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 18 May 2022
- Start date
- 17 May 2022
- Primary completion date
- 15 Dec 2023
- Lead sponsor
- Nutricia UK Ltd
- Diseases
- Childhood cancers
- NCT number
- NCT05411848
What you commit to
- Study type: Interventional
- Participants enrolled: 42
- From 17 May 2022 to the primary completion date, 15 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving parenteral nutrition
- Patients receiving inpatient care
Other illness
- 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))
- Allergy to any study product ingredients
Other
- Known pregnancy or lactation
- Participation in other clinical intervention studies within 1 month of this study
- Investigator concern regarding ability or willingness of patient to comply with the study requirements.
Who the study is looking for
- Male or female
- ≥16 years of age
- Using or requiring an enteral tube feed in the community as part of nutritional management plan
- Expected to receive at least 1000kcal/day (one bottle) from one of the study products
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nutricia Ltd. Coordinator of this site? Confirm its status | Trowbridge | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.