2kcal Tube Feed Study

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

2kcal HP PlantBased

About this trial

This is an interventional treatment trial for Enteral Nutrition

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Nutricia Ltd.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm 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

Outcomes

Primary Outcome Measures

Gastrointestinal tolerance

A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity (none, mild, moderate or severe) of common gastrointestinal symptoms (diarrhoea, constipation, bloating, abdominal discomfort, vomiting and nausea).

Secondary Outcome Measures

Acceptability

Acceptability (e.g., liking, ease of use, preference) will be assessed by a questionnaire. Questions will be rated on a 7-point Likert scale.

Compliance

Compliance with the study product prescription (%) will be assessed daily by recording how much of the study product was prescribed compared to the amount administered.

Dietary intake

A 24-h dietary recall will be conducted to record all food, drink and nutritional feeds taken in the 24 hours prior for analysis of of nutritional intake (i.e., total energy and macro- and micronutrients).

Anthropometry

Body weight (kg) will be measured using standard methods to the nearest 0.1kg using a weighing scale without heavy clothing. Height will be measured at baseline only using standard measures to the nearest 0.1cm, without shoes or socks. . Height and weight measures will be used to calculate body mass index (BMI).

Dietetic goal

A dietetic goal (e.g., weight increase/maintenance, improved/maintained GI tolerance, improved/maintained compliance) will be set by the investigating dietitian at baseline (Day 1) for each patient. At the end of the intervention period, the investigating dietitian will assess and note if the dietetic goal was met.

Safety (Adverse events)

Adverse events will be recorded throughout the study

Full Information

NCT ID

NCT05411848

First Posted

May 18, 2022

Last Updated

June 6, 2022

Sponsor

Nutricia UK Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05411848

Brief Title

2kcal Tube Feed Study

Official Title

Evaluation of a Nutritionally Complete, Plant-based, High Energy, High Protein, Enteral Tube Feed in Adults

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 17, 2022 (Actual)

Primary Completion Date

December 30, 2022 (Anticipated)

Study Completion Date

December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nutricia UK Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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. Secondary aims are to determine the effects on compliance, acceptability, anthropometry, nutrient intake, and safety. This is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Enteral Nutrition, Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm 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

Intervention Type

Dietary Supplement

Intervention Name(s)

2kcal HP PlantBased

Intervention 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

Primary Outcome Measure Information:

Title

Gastrointestinal tolerance

Description

A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity (none, mild, moderate or severe) of common gastrointestinal symptoms (diarrhoea, constipation, bloating, abdominal discomfort, vomiting and nausea).

Time Frame

Baseline to end of intervention

Secondary Outcome Measure Information:

Title

Acceptability

Description

Acceptability (e.g., liking, ease of use, preference) will be assessed by a questionnaire. Questions will be rated on a 7-point Likert scale.

Time Frame

Baseline to end of intervention (7-28 days)

Title

Compliance

Description

Compliance with the study product prescription (%) will be assessed daily by recording how much of the study product was prescribed compared to the amount administered.

Time Frame

Baseline to end of intervention (7-28 days)

Title

Dietary intake

Description

A 24-h dietary recall will be conducted to record all food, drink and nutritional feeds taken in the 24 hours prior for analysis of of nutritional intake (i.e., total energy and macro- and micronutrients).

Time Frame

Baseline to end of intervention (7-28 days)

Title

Anthropometry

Description

Body weight (kg) will be measured using standard methods to the nearest 0.1kg using a weighing scale without heavy clothing. Height will be measured at baseline only using standard measures to the nearest 0.1cm, without shoes or socks. . Height and weight measures will be used to calculate body mass index (BMI).

Time Frame

Baseline to end of intervention (7-28 days)

Title

Dietetic goal

Description

A dietetic goal (e.g., weight increase/maintenance, improved/maintained GI tolerance, improved/maintained compliance) will be set by the investigating dietitian at baseline (Day 1) for each patient. At the end of the intervention period, the investigating dietitian will assess and note if the dietetic goal was met.

Time Frame

Baseline to end of intervention (7-28 days)

Title

Safety (Adverse events)

Description

Adverse events will be recorded throughout the study

Time Frame

Baseline to end of intervention (7-28 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

No

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Corbin Griffen, PhD

Phone

07733361509

Email

corbin.griffen@nutricia.com

First Name & Middle Initial & Last Name or Official Title & Degree

Gary Hubbard, PhD

Phone

07738024720

Email

gary.hubbard@nutricia.com

Facility Information:

Facility Name

Nutricia Ltd.

City

Trowbridge

State/Province

Wiltshire

ZIP/Postal Code

BA14 0XQ

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact: