Enteral NutritionNCT05411848
2kcal Tube Feed Study
A study testing 2kcal HP PlantBased in people with Enteral Nutrition and Cancer, run by Nutricia UK Ltd at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Enteral Nutrition, Cancer
- What is being tested?
- 2kcal HP PlantBased
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 May 2022to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Nutritionally Complete, Plant-based, High Energy, High Protein, Enteral Tube Feed in Adults
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.
- Conditions
- Enteral Nutrition, Cancer
- Being tested
- 2kcal HP PlantBased
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2kcal HP PlantBasedDietary supplement
Patients will receive a minimum of 1 bottle per day of either (or both of) 2kcal HP PlantBased and/or 2kcal HP PlantBased MultiFibre Tube Feeds for a minimum of 7 days and a maximum of 28 days. During the 12-month follow-up, patients will have access to the same trial prescription as per the 28-day intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients will receive a minimum of 1 bottle per day of either (or both of) 2kcal HP PlantBased and/or 2kcal HP PlantBased MultiFibre Tube Feeds for a minimum of 7 days and a maximum of 28 days. During the 12-month follow-up, patients will have access to the same trial prescription as per the 28-day intervention period. Receives: Dietary Supplement: 2kcal HP PlantBased |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gastrointestinal tolerance
A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity (none, mild, moderate or severe) of common gastrointestinal symptoms (diarrhoea, constipation, bloating, abdominal discomfort, vomiting and nausea).
Measured: Change from baseline (Day 1) to end of intervention (7-28 days)
Change in gastrointestinal tolerance
A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity
Measured: Change from baseline (Day 1) to end of follow-up (12 months)
Secondary outcomes (9)
Acceptability
Acceptability (e.g., liking, ease of use, preference) will be assessed by a questionnaire. Questions will be rated on a 7-point Likert scale.
Measured: Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Compliance
Compliance with the study product prescription (%) will be assessed daily by recording how much of the study product was prescribed compared to the amount administered.
Measured: Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Dietary intake
A 24-h dietary recall will be conducted to record all food, drink and nutritional feeds taken in the 24 hours prior for analysis of of nutritional intake (i.e., total energy and macro- and micronutrients).
Measured: Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Anthropometry
Body weight (kg) will be measured using standard methods to the nearest 0.1kg using a weighing scale without heavy clothing. Height will be measured at baseline only using standard measures to the nearest 0.1cm, without shoes or socks. . Height and weight measures will be used to calculate body mass index (BMI).
Measured: Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Dietetic goal
A dietetic goal (e.g., weight increase/maintenance, improved/maintained GI tolerance, improved/maintained compliance) will be set by the investigating dietitian at baseline (Day 1) for each patient. At the end of the intervention period, the investigating dietitian will assess and note if the dietetic goal was met.
Measured: Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Safety (Adverse events)
Adverse events will be recorded throughout the study
Measured: Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Calf circumference
Calf circumference (of the dominant leg) will be measured using standard measures to the nearest 0.1cm using a measuring tape
Measured: 6-months to 12-months follow-up
Handgrip strength
Dominant handgrip strength (kg) will be assessed using a handgrip dynamometer
Measured: 6-months to 12-months follow-up
30-s Chair Stand Test
Number of times patients can stand up and sit down from a chair as many times as possible within 30 seconds.
Measured: 6-months to 12-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start17 May 2022
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411848
- Sponsor's protocol ID
- 2KCAL2022
- Status last verified
- Feb 2025
- First submitted
- 18 May 2022
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Nutritionally Complete, Plant-based, High Energy, High Protein, Enteral Tube Feed in Adults
- ClinicalTrials.gov ID
- NCT05411848
- Acronym / sponsor ID
- 2KCAL2022
- Conditions
- Enteral Nutrition, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Nutricia UK LtdIndustry (pharma, biotech, devices)
- Study start
- 17 May 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: 2kcal HP PlantBasedPatients will receive a minimum of 1 bottle per day of either (or both of) 2kcal HP PlantBased and/or 2kcal HP PlantBased MultiFibre Tube Feeds for a minimum of 7 days and a maximum of 28 days. During the 12-month follow-up, patients will have access to the same trial prescription as per the 28-day intervention period. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2kcal HP PlantBasedPatients will receive a minimum of 1 bottle per day of either (or both of) 2kcal HP PlantBased and/or 2kcal HP PlantBased MultiFibre Tube Feeds for a minimum of 7 days and a maximum of 28 days. During the 12-month follow-up, patients will have access to the same trial prescription as per the 28-day intervention period. | Dietary supplement | Intervention |
Primary outcome
Change in gastrointestinal tolerance
Time frame: Change from baseline (Day 1) to end of intervention (7-28 days)
A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity (none, mild, moderate or severe) of common gastrointestinal symptoms (diarrhoea, constipation, bloating, abdominal discomfort, vomiting and nausea).
Change in gastrointestinal tolerance
Time frame: Change from baseline (Day 1) to end of follow-up (12 months)
A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity
9 secondary outcomes
Acceptability
Time frame: Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Compliance
Time frame: Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Dietary intake
Time frame: Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Anthropometry
Time frame: Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Dietetic goal
Time frame: Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Safety (Adverse events)
Time frame: Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Calf circumference
Time frame: 6-months to 12-months follow-up
Handgrip strength
Time frame: 6-months to 12-months follow-up
30-s Chair Stand Test
Time frame: 6-months to 12-months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Enteral Nutrition
Enrolling by invitation
Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
Crohn's Disease, Active
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
Enrolling by invitation
No DIET Trial: Dogmatic Interruption of Enteral nuTrition
Gastrostomy, Tracheostomy
Recruiting
Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
Enteral Feeding Intolerance
Not yet recruitingObservational study
Enteral Feeding in Mechanically Ventilated Children
Critical Illness, Mechanical Ventilation Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2kcal HP PlantBased in people with Enteral Nutrition and Cancer, run by Nutricia UK Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gastrointestinal tolerance (time frame: Change from baseline (Day 1) to end of intervention (7-28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.