2kcal Tube Feed Study

NCT05411848 | Completed

• 1 other identifier: 2KCAL2022
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to investigate the effects of a plant-based, high energy, high protein tube feed with and without inclusion of fibre on gastrointestinal tolerance in adult patients who require nutritional support via enteral tube feeding over a 28-day period, followed by a 12-month follow-up. Secondary aims are to determine the effects on compliance, acceptability, anthropometry, nutrient intake, and physical function. This is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period and a 1-year follow-up.

Conditions

Enteral Nutrition; Cancer

Outcome Measures

Primary Outcomes (2)

• Change in gastrointestinal tolerance

  A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity (none, mild, moderate or severe) of common gastrointestinal symptoms (diarrhoea, constipation, bloating, abdominal discomfort, vomiting and nausea).

  Change from baseline (Day 1) to end of intervention (7-28 days)

• Change in gastrointestinal tolerance

  A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity

  Change from baseline (Day 1) to end of follow-up (12 months)

Secondary Outcomes (9)

• Acceptability

  Baseline to end of intervention (7-28 days) and end of follow-up (12 months)

• Compliance

  Baseline to end of intervention (7-28 days) and end of follow-up (12 months)

• Dietary intake

  Baseline to end of intervention (7-28 days) and end of follow-up (12 months)

• Anthropometry

  Baseline to end of intervention (7-28 days) and end of follow-up (12 months)

• Dietetic goal

  Baseline to end of intervention (7-28 days) and end of follow-up (12 months)

Study Arms (1)

Intervention

EXPERIMENTAL

Patients will receive a minimum of 1 bottle per day of either (or both of) 2kcal HP PlantBased and/or 2kcal HP PlantBased MultiFibre Tube Feeds for a minimum of 7 days and a maximum of 28 days. During the 12-month follow-up, patients will have access to the same trial prescription as per the 28-day intervention period.

Dietary Supplement: 2kcal HP PlantBased

Interventions

2kcal HP PlantBased DIETARY_SUPPLEMENT

Patients will receive a minimum of 1 bottle per day of either (or both of) 2kcal HP PlantBased and/or 2kcal HP PlantBased MultiFibre Tube Feeds for a minimum of 7 days and a maximum of 28 days. During the 12-month follow-up, patients will have access to the same trial prescription as per the 28-day intervention period.

Intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• ≥16 years of age
• Using or requiring an enteral tube feed in the community as part of nutritional management plan
• Expected to receive at least 1000kcal/day (one bottle) from one of the study products

You may not qualify if:

• 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 receiving inpatient care
• Known pregnancy or lactation
• Participation in other clinical intervention studies within 1 month of this study
• Allergy to any study product ingredients
• Investigator concern regarding ability or willingness of patient to comply with the study requirements.

Sponsors & Collaborators

• Nutricia UK Ltd: lead

Study Sites (1)

Nutricia Ltd.

Trowbridge, Wiltshire, BA14 0XQ, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Design

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

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: June 9, 2022
• Study Start: May 17, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)