Меню
Идёт набор NCT07422935

Plant-Protein Dominant Tube Feed Study

Без фазы С лечением Enteral Nutrition (Food for Special Medical Purposes) Enteral Feeds

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Plant-protein dominant enteral feed, Animal-protein dominant enteral feed.
Кому может быть актуально
Состояния в реестре: Enteral Nutrition (Food for Special Medical Purposes), Enteral Feeds. Базовые параметры: от 16 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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

Вмешательства

  • Пищевая добавка 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.
  • Пищевая добавка 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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Великобритания · 1 центр
  • Nutricia Ltd — Trowbridge

Идентификаторы

NCT: NCT07422935 · PPD2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗