NCT03140371

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 14, 2017

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

5.5 years

First QC Date

February 21, 2017

Last Update Submit

November 24, 2023

Conditions

MalnutritionMalabsorption

Keywords

Enteral feedingOral nutritional supplementsPeptide-based feedHydrolysed feedSemi-elemental feed

Outcome Measures

Primary Outcomes (1)

  • Gastro-intestinal tolerance (change is assessed at different timepoints)

    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 Outcomes (6)

  • Compliance with feed prescription

    28 days

  • Acceptability

    1 day (Day 28)

  • Weight (change will be assessed at different timepoints)

    To be completed at Baseline and Day 28 (2 days)

  • Height (change will be assessed at different timepoints)

    To be completed at Baseline and Day 28 (2 days)

  • Nutrient intake

    To be completed at Baseline and Day 28 (2 days)

  • +1 more secondary outcomes

Study Arms (1)

High energy high protein peptide feed

EXPERIMENTAL

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

Interventions

High energy high protein peptide feed studyDIETARY_SUPPLEMENT

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) .

High energy high protein peptide feed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Cumbria Partnership NHS Foundation Trust

Whitehaven, Cumbria, CA28 8JG, United Kingdom

Location

Derby Teaching Hospitals NHS Foundation Trust

Derby, Derbyshire, DE22 3NE, United Kingdom

Location

Gloucestershire Hospitals NHS Foundation Trust

Gloucester, Gloucestershire, GL1 3NN, United Kingdom

Location

Royal Surrey County Hospital NHS Foundation Trust

Guildford, Lonodn, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Location

Frimley Health NHS Foundation Trust

Frimley, United Kingdom

Location

Guys and St Thomas NHS Foundation Trust

London, United Kingdom

Location

Lewisham and Greenwich NHS Foundation Trust

London, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

Location

Great Western Hospitals NHS Foundation Trust

Swindon, United Kingdom

Location

MeSH Terms

Conditions

MalnutritionMalabsorption Syndromes

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2017

First Posted

May 4, 2017

Study Start

July 14, 2017

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

November 27, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(10)