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Recruiting NCT07422935

Plant-Protein Dominant Tube Feed Study

No phase Interventional Enteral Nutrition (Food for Special Medical Purposes) Enteral Feeds

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Plant-protein dominant enteral feed, Animal-protein dominant enteral feed.
Who it may be relevant to
Registry conditions: Enteral Nutrition (Food for Special Medical Purposes), Enteral Feeds. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Exploratory Randomised, Controlled Trial To Evaluate The Impact Of Four Nutritionally Complete, Plant-Protein Dominant, Enteral Tube Feeds On Long Term Outcomes In Community-Based Adults

Overview

This study aims to determine whether a reformulated plant-protein dominant protein blend in four existing enteral tube feeds is as effective as animal-protein dominant formulations in patients who are tube fed at home. This is an exploratory randomised, controlled, trial with a 3-day baseline period. Adult home tube feeding patients will be randomised to receive either a plant-protein dominant formulation or a control product (an animal-protein dominant formulation) for a 3-month intervention period followed by a 6-month and 12-month follow-up. The outcomes include gastrointestinal tolerance, compliance, acceptability, anthropometry, nutrient intake, and physical function

Interventions

  • Dietary supplement Plant-protein dominant enteral feed
    Patients randomised to the Intervention Group will continue their existing tube feed for 3 days (baseline period) after which they will then receive one (or a combination) of the 4 plant-protein dominant enteral feeds (1kcal/ml or 1.5kcal/ml, with or without fibre) for 3 months. Patients who chose to remain on the study feed following the duration of the trial will be invited to participate in the full 12-month follow up (an additional 9 months), where data will be collected at 6- and 12-months.
  • Dietary supplement Animal-protein dominant enteral feed
    Patients randomised to the Control Group will continue their existing tube feed for 3 days (baseline period) after which they will then receive one (or a combination) of the 4 animal-protein dominant control feeds (1kcal/ml or 1.5kcal/ml, with or without fibre) for 3 months. Patients who chose to remain on the study feed following the duration of the trial will be invited to participate in the full 12-month follow up (an additional 9 months), where data will be collected at 6- and 12-months. The

Primary outcome measures

  • Change in gastrointestinal tolerance [Time frame: Change from baseline (Day 1) to end of intervention (Day 93) and end of follow up (12 months)]
  • Acceptability [Time frame: Baseline (Day 1) to end of intervention (Day 93) and end of follow up (12 months)]
  • Compliance [Time frame: Baseline to end of intervention (93 days) and end of follow-up (12 months)]
  • Nutritional intake [Time frame: Baseline to end of intervention (Day 93) and end of follow-up (12 months)]
  • Body weight [Time frame: Baseline to end of intervention (Day 93) and end of follow-up (12 months)]
  • Height [Time frame: Baseline to end of intervention (Day 93) and end of follow-up (12 months)]
  • Calf circumference [Time frame: Baseline to end of intervention (Day 93) and end of follow-up (12 months)]
  • 30-s Chair Stand Test [Time frame: Baseline to end of intervention (Day93) and end of follow-up (12 months)]
  • Handgrip strength [Time frame: Baseline to end of intervention (Day93) and end of follow-up (12 months)]
  • Hand Grip Fatiguability [Time frame: Baseline to end of intervention (Day93) and end of follow-up (12 months)]

Eligibility criteria

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 500ml (≥500kcal) per day 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • Nutricia Ltd — Trowbridge

Identifiers

NCT: NCT07422935 · PPD2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗