NutritionNCT03168243
High Energy High Protein Tube Feed Study
A study testing High Energy High Protein Tube Feed in people with Nutrition, run by Nutricia UK Ltd at 7 sites in United Kingdom.
Trial summary
Enteral tube feeds are commonly used to meet the entire or partial nutritional requirements of patients with disease-related malnutrition and other conditions who need nutrition support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutrition
- What is being tested?
- High Energy High Protein Tube Feed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 1 Jun 2017to 31 May 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Age 18 years and over
- Requiring tube feeding in the community to meet nutritional requirements
- Expected to receive at least 500kcal from tube feeding
- Capacity to consent
Who cannot join
- Patients 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 in intensive care
- Patients with galactosaemia or severe lactose intolerance
- Participation in other clinical studies within 2 weeks prior to entry of this study
- Inability to provide informed consent
- Investigator concern around willingness/ability of patient to comply with protocol requirements
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Somerset Partnership NHS Foundation Trust
Bridgwater, Somerset, TA6 4RN
University Hospitals Bristol
Bristol, BS2 8HW
Aneurin Bevan University Health Board
Caerleon, NP16 3XQ
Lewisham Health Care NHS Trust
Lewisham, London, SE13 6LH
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
Royal Wolverhampton NHS Trust
Wolverhampton, WV10 0QP
Western Sussex Hospitals NHS Trust
Worthing, West Sussex, BN11 2DH
About this study
Official title: Evaluating the Tolerance, Compliance and Acceptability of a Nutritionally Complete, High Energy, High Protein, Enteral Feed in Adults - a Pilot Study
Enteral tube feeds are commonly used to meet the entire or partial nutritional requirements of patients with disease-related malnutrition and other conditions who need nutrition support. A large proportion of tube fed patients have increased protein and/or energy requirements due to a higher body mass or increased metabolic stress as a result of disease, surgery or trauma. A high energy, high protein feed has been developed to help meet the needs of such patients. The aim of this study is to investigate the tolerance, compliance and acceptability of this high energy high protein tube feed in adult patients who require nutritional support via tube feeding. 50 eligible patients requiring tube feeding will receive the high energy, high protein feed, according to nutritional requirements for 4 weeks. The primary outcome is nutritional intake, and secondary outcomes include gastrointestinal (GI) tolerance, compliance, acceptability and functional measures. Additional exploratory outcomes of quality of life and micronutrient levels will also be investigated.
Read the detailed description
Introduction
The present study will investigate the effect of a high energy, high protein tube feed in patients requiring enteral feeding in the community. The primary objective is to evaluate the effect of daily intake of the high energy, high protein tube feed, in addition to appropriate nutritional management, on total nutrient intakes for 4 weeks. The secondary objectives are to evaluate the effect of daily intake of the feed on gastrointestinal tolerance, compliance, acceptability and functional measures. Additional exploratory measures will be quality of life and micronutrient levels. Enteral tube feeding patients will be recruited by the dietitians responsible for their care, from a variety of dietetic services across the United Kingdom. Potential participants that require a high energy, high protein tube feed will already be known to the Investigating Dietitian or dietetic team at the investigating sites or will be referred to the dietetic service during the duration of the study.
Intervention
Following a 3 day baseline period, each patient will receive the high energy, high protein tube feed for a period of 4 weeks (28 days). The appropriate feed and prescription will be determined on an individual basis by the Dietitian responsible for the patient's nutritional management, based on the patient's clinical requirement and preference and the Dietitian's clinical judgement.
The study feed is classed as a 'Dietary Food for Special Medical Purposes' (EC Directive 1999/21/EC, 1999).
Outcome measures
- Nutrient intake (energy, protein, fluid and micronutrients)
- Gastro-intestinal tolerance Gastro-intestinal tolerance will be measured using a standardised gastro-intestinal tolerance questionnaire.
- Compliance with feed prescription Compliance with feed prescription will be assessed daily throughout the study
- Acceptability Feed acceptability, such as preference and ease of use will be assessed at the end of study.
- Anthropometry Weight and height will be measured where possible using standard measures.
- Patient history Previous nutritional support provided to the patient, previous enteral feeding products prescribed, history of intolerance, the need for a high energy, high protein feed, weight history and other relevant dietetic history.
- Muscle Function (Hand Grip Strength)
- Quality of life
- Micronutrients levels
Statistical aspects
As this is a pilot study no power calculation was undertaken. The sample size of this trial is similar to other published trials of tube feeds in patient populations. In addition to helping to inform clinical practice, the data collected will also be used to support an application to the Advisory Committee of Borderline Substances (ACBS). Recruiting a sample of 50 patients should enable sufficient data to be collected to meet ACBS requirements for the study, while allowing for drop outs during the study period.
Data will be analysed using repeated measures analysis of variance (ANOVA) or t-test where appropriate. Categorical data will be analysed using appropriate methods (e.g. chi-squared). Interim analysis may be undertaken after 30 patients have been recruited. Statistical analysis will be undertaken using IBM SPSS version 23.0 Armonk, New York, USA.
Ethical Considerations
This study will be undertaken in adults with capacity to consent only. In line with the guidance of the Medical Research Council, written informed consent will be obtained for each participant taking part in the study. The investigator will ensure that the study will be conducted in full conformance with the principles of the 'Declaration of Helsinki' (64th WMA General Assembly, Fortaleza, Brazil, October 2013) and with the laws and regulations of the country in which the research is conducted, whichever affords the greater protection to the individual.
Study Monitoring
Monitoring will be organised by the sponsor to evaluate the progress of the study, verify the accuracy and completeness of the Case Report Forms (CRFs) and to ensure adherence to the protocol. Monitoring visits will be scheduled periodically in consultation with the investigator. During monitoring, the study monitor will need access to all patient's study records and raw data used for and generated during the study needed to verify the data in the CRF. If necessary, the investigator must provide the monitor any required background data.
Confidentiality
On recruitment to the study, all participants will be allocated a unique study number, which will be the only identifier on all participant data that will leave the institution involved. For patients consenting to provide blood samples, names will be required to be stored with blood sample results. These results will be accessible by the Investigating Dietitian responsible for the patient's care. For the purposes of data analysis and any publication and dissemination of the data, all results will be analysed and identified using the patient's unique study number only. No identifiable personal data will be published.
- Conditions
- Nutrition
- Being tested
- High Energy High Protein Tube Feed
- Keywords
- nutrition support, home enteral feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Energy High Protein Tube FeedDietary supplement
Following a 3 day baseline period all patients will receive the high energy, high protein tube feed for a period of 4 weeks (28 days).
| Study group | Role | What they receive |
|---|---|---|
| High Energy High Protein Tube Feed | Experimental | As study is a single arm design, all patients will be in the intervention group. The will act as their own control by means of a 3 day baseline period. All patients in the study will receive the same intervention, the high energy high protein tube feed, in quantities specified by their dietitian based on their nutritional requirements. Receives: Dietary Supplement: High Energy High Protein Tube Feed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nutrient intakes (energy, protein, fluid and micronutrients)
Nutrient intakes, including the intake of all nutrition provided (including the study feed, other enteral tube feeding, foods, drinks and oral nutritional supplements) will be recorded using 24hr diet recalls. Nutritics® (https://www.nutritics.com/p/references), a dietary analysis program, will be used to calculate energy, protein, micronutrient and fluid intakes.
Measured: Measurements will be taken at Baseline (DAY 1) and End of Study (DAY 31).
Secondary outcomes (6)
Gastro-intestinal tolerance
Tolerance will be recorded using a standardised gastro-intestinal tolerance questionnaire, measuring incidence and severity of gastro-intestinal symptoms and Bristol Stool Chart© type and frequency of bowel movements, to be completed by the patient.
Measured: Gastro-intestinal tolerance will be recorded at baseline (DAY 1, 2 and 3) and on days 4, 5, and 6 of the study (the first 3 days the patient is taking the study feed) and once at the end of each week the patient is taking the feed.
Compliance with feed prescription measured via daily feed intake recoding
Compliance will be assessed daily throughout the Baseline period and Intervention period by recording how much study feed was received, to be recorded by the patient or carer. The amount prescribed by the Dietitian will be recorded at the start of the study, and any changes to this prescription also noted. Compliance will be calculated as feed taken as a percentage of feed prescribed.
Measured: Every day throughout study completion, 31 days in total.
Acceptability
Feed acceptability (preference, ease of use) will be assessed at the end of study by a questionnaire completed by the patient or carer.
Measured: End of study (DAY 31)
Muscle Function (hand grip strength)
Hand grip strength will be measured, where possible, in all patients in the dominant arm using a handgrip dynamometer. Three measurements will be taken and the mean used for analysis.
Measured: Measurements will be taken at Baseline (DAY 1) and End of Study (DAY 31).
EQ-5D Quality of life
Quality of life will be measured using the EQ-5D questionnaire.
Measured: Measurements will be taken at Baseline (DAY 1) and End of Study (DAY 31).
Micronutrient status
In a subset of patients blood samples will be taken and analysed to assess micronutrient status.
Measured: Measurements will be taken at Baseline (DAY 1) and End of Study (DAY 31).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 Jun 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single arm, longitudinal, interventional, multi-centre study.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Stratton, PhD, Principal investigator, Nutricia Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168243
- Sponsor's protocol ID
- NPPE001
- Status last verified
- Sep 2019
- First submitted
- 22 May 2017
- Last updated
- 1 Oct 2019
- 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 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Tolerance, Compliance and Acceptability of a Nutritionally Complete, High Energy, High Protein, Enteral Feed in Adults - a Pilot Study
- ClinicalTrials.gov ID
- NCT03168243
- Acronym / sponsor ID
- NPPE001
- Conditions
- Nutrition
- Keywords
- nutrition support, home enteral feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Nutricia UK LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 30 May 2017 (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.
Enteral tube feeds are commonly used to meet the entire or partial nutritional requirements of patients with disease-related malnutrition and other conditions who need nutrition support. A large proportion of tube fed patients have increased protein and/or energy requirements due to a higher body mass or increased metabolic stress as a result of disease, surgery or trauma. A high energy, high protein feed has been developed to help meet the needs of such patients. The aim of this study is to investigate the tolerance, compliance and acceptability of this high energy high protein tube feed in adult patients who require nutritional support via tube feeding. 50 eligible patients requiring tube feeding will receive the high energy, high protein feed, according to nutritional requirements for 4 weeks. The primary outcome is nutritional intake, and secondary outcomes include gastrointestinal (GI) tolerance, compliance, acceptability and functional measures. Additional exploratory outcomes of quality of life and micronutrient levels will also be investigated.
Detailed description
Introduction
The present study will investigate the effect of a high energy, high protein tube feed in patients requiring enteral feeding in the community. The primary objective is to evaluate the effect of daily intake of the high energy, high protein tube feed, in addition to appropriate nutritional management, on total nutrient intakes for 4 weeks. The secondary objectives are to evaluate the effect of daily intake of the feed on gastrointestinal tolerance, compliance, acceptability and functional measures. Additional exploratory measures will be quality of life and micronutrient levels. Enteral tube feeding patients will be recruited by the dietitians responsible for their care, from a variety of dietetic services across the United Kingdom. Potential participants that require a high energy, high protein tube feed will already be known to the Investigating Dietitian or dietetic team at the investigating sites or will be referred to the dietetic service during the duration of the study.
Intervention
Following a 3 day baseline period, each patient will receive the high energy, high protein tube feed for a period of 4 weeks (28 days). The appropriate feed and prescription will be determined on an individual basis by the Dietitian responsible for the patient's nutritional management, based on the patient's clinical requirement and preference and the Dietitian's clinical judgement.
The study feed is classed as a 'Dietary Food for Special Medical Purposes' (EC Directive 1999/21/EC, 1999).
Outcome measures
- Nutrient intake (energy, protein, fluid and micronutrients)
- Gastro-intestinal tolerance Gastro-intestinal tolerance will be measured using a standardised gastro-intestinal tolerance questionnaire.
- Compliance with feed prescription Compliance with feed prescription will be assessed daily throughout the study
- Acceptability Feed acceptability, such as preference and ease of use will be assessed at the end of study.
- Anthropometry Weight and height will be measured where possible using standard measures.
- Patient history Previous nutritional support provided to the patient, previous enteral feeding products prescribed, history of intolerance, the need for a high energy, high protein feed, weight history and other relevant dietetic history.
- Muscle Function (Hand Grip Strength)
- Quality of life
- Micronutrients levels
Statistical aspects
As this is a pilot study no power calculation was undertaken. The sample size of this trial is similar to other published trials of tube feeds in patient populations. In addition to helping to inform clinical practice, the data collected will also be used to support an application to the Advisory Committee of Borderline Substances (ACBS). Recruiting a sample of 50 patients should enable sufficient data to be collected to meet ACBS requirements for the study, while allowing for drop outs during the study period.
Data will be analysed using repeated measures analysis of variance (ANOVA) or t-test where appropriate. Categorical data will be analysed using appropriate methods (e.g. chi-squared). Interim analysis may be undertaken after 30 patients have been recruited. Statistical analysis will be undertaken using IBM SPSS version 23.0 Armonk, New York, USA.
Ethical Considerations
This study will be undertaken in adults with capacity to consent only. In line with the guidance of the Medical Research Council, written informed consent will be obtained for each participant taking part in the study. The investigator will ensure that the study will be conducted in full conformance with the principles of the 'Declaration of Helsinki' (64th WMA General Assembly, Fortaleza, Brazil, October 2013) and with the laws and regulations of the country in which the research is conducted, whichever affords the greater protection to the individual.
Study Monitoring
Monitoring will be organised by the sponsor to evaluate the progress of the study, verify the accuracy and completeness of the Case Report Forms (CRFs) and to ensure adherence to the protocol. Monitoring visits will be scheduled periodically in consultation with the investigator. During monitoring, the study monitor will need access to all patient's study records and raw data used for and generated during the study needed to verify the data in the CRF. If necessary, the investigator must provide the monitor any required background data.
Confidentiality
On recruitment to the study, all participants will be allocated a unique study number, which will be the only identifier on all participant data that will leave the institution involved. For patients consenting to provide blood samples, names will be required to be stored with blood sample results. These results will be accessible by the Investigating Dietitian responsible for the patient's care. For the purposes of data analysis and any publication and dissemination of the data, all results will be analysed and identified using the patient's unique study number only. No identifiable personal data will be published.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single arm, longitudinal, interventional, multi-centre study.
| Arm | Type | Receives |
|---|---|---|
| High Energy High Protein Tube Feed | Experimental | Dietary Supplement: High Energy High Protein Tube FeedAs study is a single arm design, all patients will be in the intervention group. The will act as their own control by means of a 3 day baseline period. All patients in the study will receive the same intervention, the high energy high protein tube feed, in quantities specified by their dietitian based on their nutritional requirements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female
- Age 18 years and over
- Requiring tube feeding in the community to meet nutritional requirements
- Expected to receive at least 500kcal from tube feeding
- Capacity to consent
Key exclusion criteria (8 listed)
- Patients 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 in intensive care
- Patients with galactosaemia or severe lactose intolerance
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 |
|---|---|---|
| High Energy High Protein Tube FeedFollowing a 3 day baseline period all patients will receive the high energy, high protein tube feed for a period of 4 weeks (28 days). | Dietary supplement | High Energy High Protein Tube Feed |
Primary outcome
Change in nutrient intakes (energy, protein, fluid and micronutrients)
Time frame: Measurements will be taken at Baseline (DAY 1) and End of Study (DAY 31).
Nutrient intakes, including the intake of all nutrition provided (including the study feed, other enteral tube feeding, foods, drinks and oral nutritional supplements) will be recorded using 24hr diet recalls. Nutritics® (https://www.nutritics.com/p/references), a dietary analysis program, will be used to calculate energy, protein, micronutrient and fluid intakes.
6 secondary outcomes
Gastro-intestinal tolerance
Time frame: Gastro-intestinal tolerance will be recorded at baseline (DAY 1, 2 and 3) and on days 4, 5, and 6 of the study (the first 3 days the patient is taking the study feed) and once at the end of each week the patient is taking the feed.
Compliance with feed prescription measured via daily feed intake recoding
Time frame: Every day throughout study completion, 31 days in total.
Acceptability
Time frame: End of study (DAY 31)
Muscle Function (hand grip strength)
Time frame: Measurements will be taken at Baseline (DAY 1) and End of Study (DAY 31).
EQ-5D Quality of life
Time frame: Measurements will be taken at Baseline (DAY 1) and End of Study (DAY 31).
Micronutrient status
Time frame: Measurements will be taken at Baseline (DAY 1) and End of Study (DAY 31).
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 1 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Rebecca Stratton, PhD principal investigator
Nutricia Ltd
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Energy High Protein Tube Feed in people with Nutrition, run by Nutricia UK Ltd at 7 sites 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 5 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 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 nutrient intakes (energy, protein, fluid and micronutrients) (time frame: Measurements will be taken at Baseline (DAY 1) and End of Study (DAY 31).). 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 1 Oct 2019; AzTrials last refreshed its copy on 26 Oct 2026.