High Energy High Protein Tube Feed Study

NCT03168243 | Completed

• 1 other identifier: NPPE001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 7

Brief 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. 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.

Conditions

Nutrition

Keywords

nutrition support, home enteral feeding

Outcome Measures

Primary Outcomes (1)

• 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.

  Measurements will be taken at Baseline (DAY 1) and End of Study (DAY 31).

Secondary Outcomes (6)

• Gastro-intestinal tolerance

  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

  Every day throughout study completion, 31 days in total.

• Acceptability

  End of study (DAY 31)

• Muscle Function (hand grip strength)

  Measurements will be taken at Baseline (DAY 1) and End of Study (DAY 31).

• EQ-5D Quality of life

  Measurements will be taken at Baseline (DAY 1) and End of Study (DAY 31).

Study Arms (1)

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.

Dietary Supplement: High Energy High Protein Tube Feed

Interventions

High Energy High Protein Tube Feed DIETARY_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).

High Energy High Protein Tube Feed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutricia UK Ltd: lead

Study Sites (7)

Lewisham Health Care NHS Trust

Lewisham, London, SE13 6LH, United Kingdom

Location

Somerset Partnership NHS Foundation Trust

Bridgwater, Somerset, TA6 4RN, United Kingdom

Location

Western Sussex Hospitals NHS Trust

Worthing, West Sussex, BN11 2DH, United Kingdom

Location

University Hospitals Bristol

Bristol, BS2 8HW, United Kingdom

Location

Aneurin Bevan University Health Board

Caerleon, NP16 3XQ, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

Location

Study Officials

• Rebecca Stratton, PhD

  Nutricia Ltd

  PRINCIPAL INVESTIGATOR

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

Model Details: This is a prospective, single arm, longitudinal, interventional, multi-centre study.

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 30, 2017
• Study Start: June 1, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (7)