Malnutrition, ChildNCT05269992
Childrens Real Food Tolerance Study
A study testing Real food products in people with Malnutrition, Child, run by Nutricia UK Ltd at 1 site in United Kingdom.
Trial summary
A prospective, longitudinal, 28-day intervention study evaluating the tolerance, compliance, acceptability and safety to two new enteral tube feed and one new oral nutritional supplement based on real food ingredients (1kcal/ml and 1.5kcal/ml enteral tube feeds and a 1.5kcal/ml oral nutritional supplement). Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Malnutrition, Child
- What is being tested?
- Real food products
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2022to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children from 1 year to 16 years of age.
- Requiring oral or enteral nutritional support from a whole protein 1kcal/ml or a 1.5kcal/ml enteral tube feed (via an existing enteral feeding tube) or oral nutritional supplement for at least 28 days.
- Expected to receive a minimum of 300kcal/day from the study product(s).
- Informed consent obtained from the patient/carer.
Who cannot join
- Total parenteral nutrition (100% of requirements).
- Allergy to any of the study product ingredients.
- Severe galactose (galactosaemia) or lactose intolerance.
- Severe hepatic, metabolic or renal dysfunction.
- Requirement for a fibre free feed.
- Requirement for a hydrolysed, elemental or any other specialised feed.
- On high intensity chemotherapy or radiation therapy, pancreatitis, chylothorax, or Inflammatory Bowel Disease.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Bristol Royal Hospital for Children
Bristol, BS2 8BJ
About this study
Official title: Tolerance, Compliance and Acceptability to a New Nutritional Feed Comprising Real Food Ingredients
A prospective, longitudinal, 28-day intervention study evaluating the tolerance, compliance, acceptability and safety to two new enteral tube feed and one new oral nutritional supplement based on real food ingredients (1kcal/ml and 1.5kcal/ml enteral tube feeds and a 1.5kcal/ml oral nutritional supplement).
Read the detailed description
Nutritional feeds in the form of either enteral tube feeds or oral nutritional supplements are commonly used to meet the entire or partial nutritional requirements of children who demonstrate faltering growth or other medical conditions where they cannot meet their nutritional requirements sufficiently either orally or with food alone. Prescribable commercially available enteral tube feeds and oral nutritional supplements are recommended for all patient groups by the National Institute for Clinical Excellence (NICE) and other professional bodies and are based on food ingredients such as milk powder, vegetable oils and vitamin/mineral mixes however, they are processed to some degree to ensure stability, sterility and standardised nutritional content.
In recent years some patient groups have begun to administer homemade blended foods via their feeding tubes, instead of using prescribable commercially available feeds, which is especially prevalent among paediatric patients. Although recognition of this practice from professional bodies is low, anecdotal evidence does show some benefits. Nonetheless, there are concerns with this practice including compromised nutritional consistency, microbiological safety and enteral pump and tube integrity. This presents a problem for some parents who wish to provide their child with a source of nutritional support based on real food without posing any additional risks. Nutricia has recognised the changing needs of these paediatric patients and has therefore extended its existing range of paediatric feeds to include new formulations which include real food ingredients whilst still maintaining sterility and a stabilised nutritional content. These new formulations are designed for children with faltering growth/disease related malnutrition from 1 year old, are suitable as a sole source of nutrition and provide a sterile, standardised consistency and nutritional content.
A clinical trial is therefore required to evaluate the tolerance, compliance, acceptability and safety of three new enteral tube feed and oral nutritional supplement formulations, based on real food ingredients (1kcal/ml and 1.5kcal/ml enteral tube feeds and a 1.5kcal/ml oral nutritional supplement). Additional outcomes include nutritional intake, anthropometrics, and gastrointestinal health-related quality of life. This is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period. During the intervention period, patients will receive the intervention feed(s) as a sole source of nutrition or alongside any additional routine nutritional management as required.
- Conditions
- Malnutrition, Child
- Being tested
- Real food products
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real food productsOther
As per arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Real food products | Experimental | The study products are 1) a 1kcal/ml enteral tube feed provided as a 500ml ready to use enteral tube feed; 2) a 1.5kcal/ml enteral tube feed provided as a 500ml ready to use enteral tube feed, and 3) a 1.5kcal/ml oral nutritional supplement provided in a 200ml ready to drink format. This study is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period aiming to recruit 60 in paediatric patients. During the intervention period, patients will receive one of the three study products (or more if deemed appropriate) for 28 days as a sole source of nutrition or alongside any additional routine nutritional management as required. As such, randomisation was not deemed suitable for this study. The appropriate study product and volume prescribed will be recommended by the investigating dietitian/nurse and agreed with the patient/parent/carer based on their clinical and nutritional requirements. Receives: Other: Real food products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal tolerance assessing abdominal discomfort, pain, nausea, reflux, regurgitation, gagging, retching, vomiting, constipation, diarrhoea, bloating and flatulence
Gastrointestinal tolerance will be assessed at baseline (day 1) in relation to patients' usual enteral tube feed, oral nutritional supplement or other nutritional regimen, and again at day 8, 15, 22 and 29 during the intervention using standardised questionnaires.Parents/carers will be asked to complete a gastrointestinal symptom score form on behalf of their child which will assess the incidence and severity of the following symptoms: abdominal discomfort, pain, nausea, reflux, regurgitation, gagging, retching, vomiting, constipation, diarrhoea, bloating and flatulence on a four-point scale (Absent, Mild, Moderate, Severe).
Measured: 29 days
Secondary outcomes (8)
Compliance
Compliance with the recommended intake of patients' currently prescribed enteral tube feed or oral nutritional supplement (if an existing user) will be assessed at baseline (day 1). Similarly, parents/carers will be asked to record how much study feed (ml) their child takes daily throughout the study period (days 2-29), which will be compared to the amount prescribed by the Dietitian
Measured: 29 days
Functionality, perception and satisfaction with the study product
The acceptability of any enteral tube feeds and oral nutritional supplements used prior to study enrolment will be recorded at baseline (day 1) and consequently study products (including perceptions around enteral tube feeding and oral nutritional supplements) will be recorded at the end of week 1 and at the end of the study period (day 29) by parents/carers using standardised questionnaires. This will assess how much users agree or disagree with various statements about the feeds such as functionality (i.e. ease of use or complications), perception and satisfaction, as well as assessing changes in opinions around enteral tube feeding or oral nutritional supplements (in relation to the product taken).
Measured: 29 days
Energy and protein intake
Energy and protein intake will be collected at baseline (day 1) and at the end of week 1 (day 8) and at the end of the study period (day 29) based on 24-hour dietary recall recorded by the Dietitian. Nutritional analysis software https://www.nutritics.com/p/home will be used to perform dietary analysis to determine energy and protein intakes.
Measured: 29 days
Gastrointestinal health-related quality of life
Gastrointestinal health-related quality of life outcomes will be collected by parents/carers at baseline (day 1), at the end of week 1 (day 8) and end of the study period (day 29). This form will record how much users feel their enteral tube feed impacts on factors such as sleep, pain, anxiety and social functioning. Participants aged 5 years and above will also be given the opportunity (where appropriate) to give self-reported answers on a simplified version.
Measured: 29 days
Height
Anthropometric data will be collected at baseline (day 1) and at the end of the study period (day 29), using standardised methods to assess growth. This will include weight (in kg) which will be recorded to the nearest 0.1kg. In those participants who are unable to stand on conventional weighing scales, sitting or hoist scales will be used where possible. Mid upper-arm circumference (in cm) will also be measured on a bare, relaxed arm (left) from the midpoint between the tip of the shoulder and the elbow and recorded to the nearest 0.1cm.
Measured: 29 days
Weight
Anthropometric data will be collected at baseline (day 1) and at the end of the study period (day 29), using standardised methods to assess growth. Height (in cm) will be recorded to the nearest 0.1cm in those able to stand. Descriptive information from growth charts will also be collected to understand growth history, and growth goals will be recorded by the Dietitian.
Measured: 29 days
Dietetic Goal
The dietetic goal of each patient will be recorded at baseline by the Dietitian and achievement of this goal (via yes/no responses) in the view of the Dietitian will be assessed at the end of the intervention (day 29).
Measured: 29 days
Adverse events
All adverse events will be recorded throughout the study on occurrence.
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 May 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition, ChildStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutricia UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269992
- Sponsor's protocol ID
- NN001
- Status last verified
- Apr 2026
- First submitted
- 16 Feb 2022
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD planned. Following completion of this trial, the results may be published in conference proceedings or as a full manuscript where all data will be mean +/- SD and not individual.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance, Compliance and Acceptability to a New Nutritional Feed Comprising Real Food Ingredients
- ClinicalTrials.gov ID
- NCT05269992
- Acronym / sponsor ID
- NN001
- Conditions
- Malnutrition, Child
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nutricia UK LtdIndustry (pharma, biotech, devices)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Mar 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.
A prospective, longitudinal, 28-day intervention study evaluating the tolerance, compliance, acceptability and safety to two new enteral tube feed and one new oral nutritional supplement based on real food ingredients (1kcal/ml and 1.5kcal/ml enteral tube feeds and a 1.5kcal/ml oral nutritional supplement).
Detailed description
Nutritional feeds in the form of either enteral tube feeds or oral nutritional supplements are commonly used to meet the entire or partial nutritional requirements of children who demonstrate faltering growth or other medical conditions where they cannot meet their nutritional requirements sufficiently either orally or with food alone. Prescribable commercially available enteral tube feeds and oral nutritional supplements are recommended for all patient groups by the National Institute for Clinical Excellence (NICE) and other professional bodies and are based on food ingredients such as milk powder, vegetable oils and vitamin/mineral mixes however, they are processed to some degree to ensure stability, sterility and standardised nutritional content.
In recent years some patient groups have begun to administer homemade blended foods via their feeding tubes, instead of using prescribable commercially available feeds, which is especially prevalent among paediatric patients. Although recognition of this practice from professional bodies is low, anecdotal evidence does show some benefits. Nonetheless, there are concerns with this practice including compromised nutritional consistency, microbiological safety and enteral pump and tube integrity. This presents a problem for some parents who wish to provide their child with a source of nutritional support based on real food without posing any additional risks. Nutricia has recognised the changing needs of these paediatric patients and has therefore extended its existing range of paediatric feeds to include new formulations which include real food ingredients whilst still maintaining sterility and a stabilised nutritional content. These new formulations are designed for children with faltering growth/disease related malnutrition from 1 year old, are suitable as a sole source of nutrition and provide a sterile, standardised consistency and nutritional content.
A clinical trial is therefore required to evaluate the tolerance, compliance, acceptability and safety of three new enteral tube feed and oral nutritional supplement formulations, based on real food ingredients (1kcal/ml and 1.5kcal/ml enteral tube feeds and a 1.5kcal/ml oral nutritional supplement). Additional outcomes include nutritional intake, anthropometrics, and gastrointestinal health-related quality of life. This is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period. During the intervention period, patients will receive the intervention feed(s) as a sole source of nutrition or alongside any additional routine nutritional management as required.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Real food products | Experimental | Other: Real food productsThe study products are 1) a 1kcal/ml enteral tube feed provided as a 500ml ready to use enteral tube feed; 2) a 1.5kcal/ml enteral tube feed provided as a 500ml ready to use enteral tube feed, and 3) a 1.5kcal/ml oral nutritional supplement provided in a 200ml ready to drink format. This study is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period aiming to recruit 60 in paediatric patients. During the intervention period, patients will receive one of the three study products (or more if deemed appropriate) for 28 days as a sole source of nutrition or alongside any additional routine nutritional management as required. As such, randomisation was not deemed suitable for this study. The appropriate study product and volume prescribed will be recommended by the investigating dietitian/nurse and agreed with the patient/parent/carer based on their clinical and nutritional requirements. |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children from 1 year to 16 years of age.
- Requiring oral or enteral nutritional support from a whole protein 1kcal/ml or a 1.5kcal/ml enteral tube feed (via an existing enteral feeding tube) or oral nutritional supplement for at least 28 days.
- Expected to receive a minimum of 300kcal/day from the study product(s).
- Informed consent obtained from the patient/carer.
Key exclusion criteria (7 listed)
- Total parenteral nutrition (100% of requirements).
- Allergy to any of the study product ingredients.
- Severe galactose (galactosaemia) or lactose intolerance.
- Severe hepatic, metabolic or renal dysfunction.
- Requirement for a fibre free feed.
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 |
|---|---|---|
| Real food productsAs per arm/group descriptions. | Other | Real food products |
Primary outcome
Gastrointestinal tolerance assessing abdominal discomfort, pain, nausea, reflux, regurgitation, gagging, retching, vomiting, constipation, diarrhoea, bloating and flatulence
Time frame: 29 days
Gastrointestinal tolerance will be assessed at baseline (day 1) in relation to patients' usual enteral tube feed, oral nutritional supplement or other nutritional regimen, and again at day 8, 15, 22 and 29 during the intervention using standardised questionnaires.Parents/carers will be asked to complete a gastrointestinal symptom score form on behalf of their child which will assess the incidence and severity of the following symptoms: abdominal discomfort, pain, nausea, reflux, regurgitation, gagging, retching, vomiting, constipation, diarrhoea, bloating and flatulence on a four-point scale (Absent, Mild, Moderate, Severe).
8 secondary outcomes
Compliance
Time frame: 29 days
Functionality, perception and satisfaction with the study product
Time frame: 29 days
Energy and protein intake
Time frame: 29 days
Gastrointestinal health-related quality of life
Time frame: 29 days
Height
Time frame: 29 days
Weight
Time frame: 29 days
Dietetic Goal
Time frame: 29 days
Adverse events
Time frame: 29 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No. No IPD planned. Following completion of this trial, the results may be published in conference proceedings or as a full manuscript where all data will be mean +/- SD and not individual.
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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 Real food products in people with Malnutrition, Child, 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 7 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: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Gastrointestinal tolerance assessing abdominal discomfort, pain, nausea, reflux, regurgitation, gagging, retching, vomiting, constipation, diarrhoea, bloating and flatulence (time frame: 29 days). 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 14 Apr 2026.