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High Energy High Protein Peptide Feed Study

Primary Purpose

Malnutrition, Malabsorption

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High energy high protein peptide feed study
Sponsored by
Nutricia UK Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malnutrition focused on measuring Enteral feeding, Oral nutritional supplements, Peptide-based feed, Hydrolysed feed, Semi-elemental feed

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cumbria Partnership NHS Foundation TrustRecruiting
  • Derby Teaching Hospitals NHS Foundation TrustRecruiting
  • Gloucestershire Hospitals NHS Foundation TrustRecruiting
  • Royal Surrey County Hospital NHS Foundation TrustRecruiting
  • University Hospitals Birmingham NHS Foundation TrustRecruiting
  • Frimley Health NHS Foundation TrustRecruiting
  • Guys and St Thomas NHS Foundation TrustRecruiting
  • Lewisham and Greenwich NHS Foundation TrustRecruiting
  • Sheffield Teaching Hospitals NHS Foundation TrustRecruiting
  • Great Western Hospitals NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High energy high protein peptide feed

Arm Description

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) .

Outcomes

Primary Outcome Measures

Gastro-intestinal tolerance (change is assessed at different timepoints)
Questionaire detailing any GI symptoms, severity and change from usual

Secondary Outcome Measures

Compliance with feed prescription
Brief questionnaire on amounts offered and amounts actually consumed, compared to recommended amount.
Acceptability
Brief tick-box questionnaire on overall liking and acceptability of product
Weight (change will be assessed at different timepoints)
Measurements of weight (kg) at baseline and end of study
Height (change will be assessed at different timepoints)
Measurements of height (cm) at baseline and end of study
Nutrient intake
24hr dietary recall at baseline and end of study, subsequently analysed in dietary software.
Patient history
A detailed patient history will be recorded at baseline

Full Information

First Posted
February 21, 2017
Last Updated
April 12, 2022
Sponsor
Nutricia UK Ltd
Collaborators
National Health Service, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT03140371
Brief Title
High Energy High Protein Peptide Feed Study
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nutricia UK Ltd
Collaborators
National Health Service, United Kingdom

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Malabsorption
Keywords
Enteral feeding, Oral nutritional supplements, Peptide-based feed, Hydrolysed feed, Semi-elemental feed

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High energy high protein peptide feed
Arm Type
Experimental
Arm Description
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) .
Intervention Type
Dietary Supplement
Intervention Name(s)
High energy high protein peptide feed study
Intervention Description
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) .
Primary Outcome Measure Information:
Title
Gastro-intestinal tolerance (change is assessed at different timepoints)
Description
Questionaire detailing any GI symptoms, severity and change from usual
Time Frame
To be completed on Days 1, 2, 3, 7, 14, 21, 26, 17 and 28
Secondary Outcome Measure Information:
Title
Compliance with feed prescription
Description
Brief questionnaire on amounts offered and amounts actually consumed, compared to recommended amount.
Time Frame
28 days
Title
Acceptability
Description
Brief tick-box questionnaire on overall liking and acceptability of product
Time Frame
1 day (Day 28)
Title
Weight (change will be assessed at different timepoints)
Description
Measurements of weight (kg) at baseline and end of study
Time Frame
To be completed at Baseline and Day 28 (2 days)
Title
Height (change will be assessed at different timepoints)
Description
Measurements of height (cm) at baseline and end of study
Time Frame
To be completed at Baseline and Day 28 (2 days)
Title
Nutrient intake
Description
24hr dietary recall at baseline and end of study, subsequently analysed in dietary software.
Time Frame
To be completed at Baseline and Day 28 (2 days)
Title
Patient history
Description
A detailed patient history will be recorded at baseline
Time Frame
To be completed at Baseline (Day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ben Green, PhD
Phone
07920587679
Email
ben.green@nutricia.com
Facility Information:
Facility Name
Cumbria Partnership NHS Foundation Trust
City
Whitehaven
State/Province
Cumbria
ZIP/Postal Code
CA28 8JG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen Fraser-Mayall
Facility Name
Derby Teaching Hospitals NHS Foundation Trust
City
Derby
State/Province
Derbyshire
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolyn Day
Facility Name
Gloucestershire Hospitals NHS Foundation Trust
City
Gloucester
State/Province
Gloucestershire
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siobhan Oldham
Facility Name
Royal Surrey County Hospital NHS Foundation Trust
City
Guildford
State/Province
Lonodn
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Phillips
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Price
Facility Name
Frimley Health NHS Foundation Trust
City
Frimley
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Palmer
Facility Name
Guys and St Thomas NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orla Hynes
Facility Name
Lewisham and Greenwich NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Robison
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean White
Facility Name
Great Western Hospitals NHS Foundation Trust
City
Swindon
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Best

12. IPD Sharing Statement

Plan to Share IPD
No

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High Energy High Protein Peptide Feed Study

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