2kcal Tube Feed Study

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05411848
• Other study ID #: 2KCAL2022
• Status: Completed
• Phase: N/A
• Start date: May 17, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: February 2024
• Source: Nutricia UK Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Enteral Nutrition

Intervention

Dietary Supplement:
• 2kcal HP PlantBased
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.

Locations

Country	Name	City	State
United Kingdom	Nutricia Ltd.	Trowbridge	Wiltshire

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia UK Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 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).	Change from baseline (Day 1) to end of intervention (7-28 days)
Primary	Change in gastrointestinal tolerance	A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity	Change from baseline (Day 1) to end of follow-up (12 months)
Secondary	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.	Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Secondary	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.	Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Secondary	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).	Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Secondary	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).	Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Secondary	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.	Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Secondary	Safety (Adverse events)	Adverse events will be recorded throughout the study	Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Secondary	Calf circumference	Calf circumference (of the dominant leg) will be measured using standard measures to the nearest 0.1cm using a measuring tape	6-months to 12-months follow-up
Secondary	Handgrip strength	Dominant handgrip strength (kg) will be assessed using a handgrip dynamometer	6-months to 12-months follow-up
Secondary	30-s Chair Stand Test	Number of times patients can stand up and sit down from a chair as many times as possible within 30 seconds.	6-months to 12-months follow-up