Acceptability and Tolerance Study of a High Energy Tube Feed with Food Derived Ingredients

Nestlé

Status: Completed

Conditions: Tolerance

Treatments: Dietary Supplement: Compleat 1.5 HP

Study type: Interventional

Funder types: Industry

Identifiers

NCT06034951

Compleat002

Details and patient eligibility

About

Enterally fed adults and children who are assessed by the dietitian as requiring an adult high-energy, fibre-containing enteral formula will be recruited. Data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) for product registration.

Full description

To evaluate the acceptability (including gastrointestinal tolerance and compliance) of a high energy, adult enteral formula with food-derived ingredients.This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a 14-day period with the new tube feed.

Participants or their caregivers will be provided with 14-day supply of the new tube feed and will be asked to complete a daily diary and short questionnaire to record information allowing assessment of the following:

• Gastrointestinal tolerance
• Compliance with prescribed feed volume

Enrollment: 16 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients requiring an enteral tube feed (taking > 60% of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition

  • Children 15 years and over
  • Adults and children requiring an adult high-energy and fibre-containing formula, as assessed by the dietitian.
  • Patients well-established and stable on enteral feeding.
  • Willingly given, written, informed consent from patient or consultee
  • Willingly given, written assent (if appropriate).

Exclusion criteria

• Inability to comply with the study protocol, in the opinion of the investigator

  • Children under 15 years of age
  • Patients receiving mechanical ventilation, sedation or inotropic support
  • Patients on total parenteral nutrition
  • Known food allergies to any ingredients (see ingredients list) or galactosaemia
  • Patients with significant renal or hepatic impairment
  • Patients with planned changes to medication or treatments during the study period which may alter gastrointestinal function (e.g. chemotherapy). Changes in medications or nutritional products during the study intervention must be documented.
  • Participation in another interventional study within 2 weeks of this study.
  • Patients with a clinical indication for a low fibre or fibre free diet as advised by the healthcare team.
  • Patients with known or suspected ileus or mechanical bowel obstruction

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Patients well established on tube feeds will act as their own control

Other group

Description:

These patients will switch from current to new tube feed to assess acceptability and tolerance

Treatment:

Dietary Supplement: Compleat 1.5 HP