2kcal Tube Feed Study

Nutricia

Status: Completed

Conditions: Enteral Nutrition; Cancer

Treatments: Dietary Supplement: 2kcal HP PlantBased

Study type: Interventional

Funder types: Industry

Identifiers

NCT05411848

2KCAL2022

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Intervention

Experimental group

Description:

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.

Treatment:

Dietary Supplement: 2kcal HP PlantBased