Feasibility of a novel nutritional supplement for surgical patients

Not Applicable

• Conditions: Sarcopenia in older abdominal surgical patients; Musculoskeletal Diseases

• Registration Number: ISRCTN83283595
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-17
• Last Update Posted: 20 November 2023
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Group 1
1.1. Patient has colorectal cancer and is due for elective surgery for cancer
1.2. Patient is over 60 years of age

Group 2
2.1. Patient has colorectal cancer and had had elective surgery for cancer
2.2. Patient is over 60 years of age

Group 3
3.1. Patient has been admitted as an emergency and has had emergency surgical intervention for abdominal conditions.Patient is over 60 years of age.

All groups
4. Patient has capacity to understand the study and give informed consent
5. Patient is capable of ingesting the oral supplement

Exclusion Criteria

1. Patient is incapable of understanding the study and giving informed consent
2. Patient is incapable of ingesting the oral supplement
3. Patients with the very rare potential complication of an allergy to nutritional supplement (sodium benzoate or sodium metabisulphites).
4. Preoperative patients (group 1) with pacemakers or similar electrical implants will be excluded as they will undergo bioelectrical impedance studies and this is a contraindication to using the analyser.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Part A:<br> 1. Nutritional intake measured using calorie count and macronutrient analysis at each breakfast<br> 2. Appetite assessment (Flint 2000) taken twice at each breakfast meal for the preoperative participants<br> 3. Palatability perceptions measured using visual analogue scales to test palatability of the supplement at single time point<br><br> Part B, measured using patient interview at a single time point<br> 1. Habitual nutritional intakes<br> 2. Compliance with the supplementation regime<br>

Secondary Outcome Measures

Name	Time	Method
<br> Part B, measured at a single time point:<br> 1. Body composition: Fat mass and muscle mass as measured by a Tanita bioelectrical impedance analyser<br> 2. Jagar dynamometer to measure grip strength<br> 3. Timed get and go test of 3 metres to assess baseline fitness<br>