High Energy High Protein Peptide Feed Study

November 24, 2023 updated by: Nutricia UK Ltd

An Evaluation of the Tolerance, Compliance and Acceptability of a Ready to Use, Liquid, High Energy, High Protein, Peptide-based Feed for Adults in Need of Nutrition Support - a Pilot Study

Oral nutritional supplements and enteral tube feeds are commonly used to meet the nutritional requirements of patients with disease-related malnutrition, or who require medical nutrition support for other reasons. Some patients may not tolerate standard formulations containing whole proteins (typically due to maldigestion/malabsorption) leading to gastrointestinal symptoms (i.e. vomiting and diarrhoea). Without appropriate management, this may lead to reduced nutritional intake, increased nutritional losses and risk of malnutrition in patients who may already have elevated nutritional requirements due to their clinical conditions.

Poor tolerance to standard feed formulations can be managed with extensively hydrolysed (peptide-based) enteral feeds, where the protein source is provided in smaller proteins. Patients with elevated nutritional requirements, poor tolerance, maldigestion and/or malabsorption often require a higher energy, higher protein feed to meet their nutritional requirements in a smaller volume of feed.

The study feed is a high energy (1.5kcal/ml), high protein (7.5g protein/100ml) peptide-based feed, available as a 500ml enteral tube feed, and a 200ml Vanilla-flavour oral nutritional supplement. The study will investigate the gastrointestinal tolerance, compliance and acceptability of the high energy, high protein peptide-based feed in 60 adult patients requiring a peptide-based feed, in several NHS sites across England. Patients will be asked to take the study feed for 28 days. Data will be recorded using questionnaires with no invasive measures.

The primary outcome is gastrointestinal tolerance with secondary outcomes of compliance, acceptability, nutrient intake and anthropometry.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Malnutrition or "undernutrition" in adults (≥18 years of age) is the deficiency of nutrients (energy, protein and micronutrients) which causes adverse effects on bodily composition, clinical and functional outcomes. Malnutrition can occur as a result of a number of factors including inadequate calorie intake, impaired nutrient absorption (malabsorption/maldigestion) or increased energy requirements usually associated with disease/illness e.g. cancer, inflammatory bowel disease and pancreatitis, and its management, e.g. chemotherapy and surgery. Patients who have or are at risk of malnutrition can be managed with a range of nutrition support strategies, including the use of oral nutritional supplements and enteral feeds (administered by feeding tubes such as nasogastric tubes, gastrostomies or jejunostomies). These feeds may provide either a sole source of nutrition or in combination with the diet.

A small group of patients requiring nutritional support experience severe malabsorption and maldigestion of nutrients (particularly protein and fat), resulting in them having an inadequate energy and nutrient supply. This may be due to inadequate functioning of the gastro-intestinal tract due to inflammation, reduced concentration of digestive enzymes and/or reduced surface area for nutrient absorption associated with some diseases and treatments. These may include patients with pancreatic enzyme deficiency (pancreatitis, pancreatic cancer, cystic fibrosis), inflammatory bowel disease, radiation enteritis and chemotherapy, short bowel syndrome, HIV-related gastrointestinal disorders, enteric fistulae or intolerance/allergy of unknown cause. Some of these patients will not be able to tolerate a standard feed containing whole protein and fat. In these cases oral nutritional supplements and enteral tube feeds known as 'extensively hydrolysed', 'semi-elemental' or 'peptide-based' with extensively digested protein (containing peptides and small proteins) and containing more easily absorbed types of fat (medium chain triglycerides (MCTs)), can help improve digestion and absorption.

Peptide-based feeds have been used effectively in the dietary management of patients with Crohn's disease, pancreatitis, pancreatectomy, radiation enteritis and chemotherapy, HIV-related GI disorders and short bowel syndrome. The use of MCTs in patients with fat (long chain triglyceride (LCT)) malabsorption has been shown to decrease steatorrhoea, decrease dyspepsia and improve nutritional status. Feed formulations with a mixture of MCTs and LCTs are also thought to provide beneficial effects.

Such specialised, ready to use feeds have been commonly used in clinical practice for many years. However, the energy density (1kcal/ml) and the protein content (4g/100ml) of some such feeds have meant that patients are often unable to tolerate the required volumes of feed either orally or via tube to meet their nutritional requirements, which are often elevated by their disease. Therefore, in order to meet the nutritional requirements of patients with poor feed tolerance, a more energy dense (1.5kcal/ml), higher protein (7.5g protein/100ml), nutritionally complete peptide-based feed for oral and tube feeding may be required.

The study feed is a high energy (1.5kcal/ml), high protein (7.5g protein/100ml) peptide-based feed, available as a 500ml enteral tube feed, and a 200ml Vanilla-flavour oral nutritional supplement. However, the tolerance, compliance and acceptability of this feed is unknown in this patient group who have complex clinical conditions. Therefore this study is required to assess gastrointestinal tolerance, compliance and acceptability of this high energy density (1.5kcal/ml), high protein (7.5g/100ml), peptide-based feed in community patients requiring nutrition support in clinical practice.

60 adult patients requiring a peptide-based feed will be recruited from several NHS sites across England. Patients will be asked to take the study feed for 4 weeks (28 days), in a quantity advised by their Dietitian. Data will be recorded at baseline, Week 4 and throughout the study using questionnaires with no invasive measures.

The primary outcome is gastrointestinal tolerance with secondary outcomes of compliance to prescribed study feed volumes, acceptability of the study feed, nutrient intake and anthropometry.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom
        • University Hospitals Birmingham NHS Foundation Trust
      • Frimley, United Kingdom
        • Frimley Health NHS Foundation Trust
      • London, United Kingdom
        • Lewisham and Greenwich NHS Foundation Trust
      • London, United Kingdom
        • Guys and St Thomas NHS Foundation Trust
      • Sheffield, United Kingdom
        • Sheffield Teaching Hospitals NHS Foundation Trust
      • Swindon, United Kingdom
        • Great Western Hospitals NHS Foundation Trust
    • Cumbria
      • Whitehaven, Cumbria, United Kingdom, CA28 8JG
        • Cumbria Partnership NHS Foundation Trust
    • Derbyshire
      • Derby, Derbyshire, United Kingdom, DE22 3NE
        • Derby Teaching Hospitals NHS Foundation Trust
    • Gloucestershire
      • Gloucester, Gloucestershire, United Kingdom, GL1 3NN
        • Gloucestershire Hospitals NHS Foundation Trust
    • Lonodn
      • Guildford, Lonodn, United Kingdom
        • Royal Surrey County Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female
  • Age 18 years and over
  • Requiring a peptide-based feed to meet nutritional requirements
  • Expected to receive at least 300kcal if taken orally or at least 500kcal if taken by tube

Exclusion Criteria:

  • Patients receiving total 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
  • Investigator concern around willingness/ability of patient to comply with protocol requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High energy high protein peptide feed

This is a one-arm study. Each patient recruited onto the study will receive the high energy, high protein peptide-based feed for a period of up to 4 weeks (28 days). The feed will be available as an enteral tube feed in a 500ml bottle, and as a Vanilla flavoured oral nutritional supplement in a 200ml plastic bottle. The appropriate feed presentation (tube feed or oral nutritional supplement) 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) .
Dietary supplement: High energy high protein peptide feed study

Each patient will receive the high energy, high protein peptide-based feed for a period of up to 4 weeks (28 days). The feed will be available as an enteral tube feed in a 500ml bottle, and as a Vanilla flavoured oral nutritional supplement in a 200ml plastic bottle. The appropriate feed presentation (tube feed or oral nutritional supplement) 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) .

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gastro-intestinal tolerance (change is assessed at different timepoints)
Time Frame: To be completed on Days 1, 2, 3, 7, 14, 21, 26, 17 and 28
Questionaire detailing any GI symptoms, severity and change from usual
To be completed on Days 1, 2, 3, 7, 14, 21, 26, 17 and 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Compliance with feed prescription
Time Frame: 28 days
Brief questionnaire on amounts offered and amounts actually consumed, compared to recommended amount.
28 days
Acceptability
Time Frame: 1 day (Day 28)
Brief tick-box questionnaire on overall liking and acceptability of product
1 day (Day 28)
Weight (change will be assessed at different timepoints)
Time Frame: To be completed at Baseline and Day 28 (2 days)
Measurements of weight (kg) at baseline and end of study
To be completed at Baseline and Day 28 (2 days)
Height (change will be assessed at different timepoints)
Time Frame: To be completed at Baseline and Day 28 (2 days)
Measurements of height (cm) at baseline and end of study
To be completed at Baseline and Day 28 (2 days)
Nutrient intake
Time Frame: To be completed at Baseline and Day 28 (2 days)
24hr dietary recall at baseline and end of study, subsequently analysed in dietary software.
To be completed at Baseline and Day 28 (2 days)
Patient history
Time Frame: To be completed at Baseline (Day 1)
A detailed patient history will be recorded at baseline
To be completed at Baseline (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nutricia UK Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Health Service, United Kingdom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HEHP16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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