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Completed

NCT Number: NCT05411848

2kcal Tube Feed Study

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.

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Key information

Conditions

Enteral Nutrition Cancer Neoplasms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutricia Ltd.

Trowbridge, Wiltshire, BA14 0XQ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Change in gastrointestinal tolerance

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

    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).

  2. Change in gastrointestinal tolerance

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

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

Secondary outcomes

  1. Acceptability

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

    Acceptability (e.g., liking, ease of use, preference) will be assessed by a questionnaire. Questions will be rated on a 7-point Likert scale.

  2. Compliance

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

    Compliance with the study product prescription (%) will be assessed daily by recording how much of the study product was prescribed compared to the amount administered.

  3. Dietary intake

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

    A 24-h dietary recall will be conducted to record all food, drink and nutritional feeds taken in the 24 hours prior for analysis of of nutritional intake (i.e., total energy and macro- and micronutrients).

  4. Anthropometry

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

    Body weight (kg) will be measured using standard methods to the nearest 0.1kg using a weighing scale without heavy clothing. Height will be measured at baseline only using standard measures to the nearest 0.1cm, without shoes or socks. . Height and weight measures will be used to calculate body mass index (BMI).

  5. Dietetic goal

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

    A dietetic goal (e.g., weight increase/maintenance, improved/maintained GI tolerance, improved/maintained compliance) will be set by the investigating dietitian at baseline (Day 1) for each patient. At the end of the intervention period, the investigating dietitian will assess and note if the dietetic goal was met.

  6. Safety (Adverse events)

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

    Adverse events will be recorded throughout the study

  7. Calf circumference

    Time frame: 6-months to 12-months follow-up

    Calf circumference (of the dominant leg) will be measured using standard measures to the nearest 0.1cm using a measuring tape

  8. Handgrip strength

    Time frame: 6-months to 12-months follow-up

    Dominant handgrip strength (kg) will be assessed using a handgrip dynamometer

  9. 30-s Chair Stand Test

    Time frame: 6-months to 12-months follow-up

    Number of times patients can stand up and sit down from a chair as many times as possible within 30 seconds.

Sponsors and collaborators

Lead sponsor

Nutricia UK Ltd

Industry

Registry information

Official study title

Evaluation of a Nutritionally Complete, Plant-based, High Energy, High Protein, Enteral Tube Feed in Adults

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2022
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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