Evaluation of a Nutritionally Complete, Plant-based, High Energy, High Protein, Enteral Tube Feed in Adults
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Enteral Nutrition
- Sponsor
- Nutricia UK Ltd
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Change in gastrointestinal tolerance
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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 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.
Outcomes
Primary Outcomes
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
- Acceptability(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))
- Safety (Adverse events)(Baseline to end of intervention (7-28 days) and end of follow-up (12 months))
- Handgrip strength(6-months to 12-months follow-up)
- Compliance(Baseline to end of intervention (7-28 days) and end of follow-up (12 months))
- Calf circumference(6-months to 12-months follow-up)
- 30-s Chair Stand Test(6-months to 12-months follow-up)
- Dietary intake(Baseline to end of intervention (7-28 days) and end of follow-up (12 months))