2kcal Tube Feed Study (NCT05411848) | Clinical Trial Compass
CompletedNot Applicable
2kcal Tube Feed Study
United Kingdom42 participantsStarted 2022-05-17
Plain-language summary
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.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Receiving parenteral nutrition
* 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))
* Patients receiving inpatient care
* Known pregnancy or lactation
* Participation in other clinical intervention studies within 1 month of this study
* Allergy to any study product ingredients
* Investigator concern regarding ability or willingness of patient to comply with the study requirements.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in gastrointestinal tolerance
Timeframe: Change from baseline (Day 1) to end of intervention (7-28 days)
2
Change in gastrointestinal tolerance
Timeframe: Change from baseline (Day 1) to end of follow-up (12 months)