search
Back to results

Whey Protein-based Enteral Nutrition Support to Improve Protein Economy in Surgical Patients

Primary Purpose

Protein Metabolism, Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Oral Nutrition Support
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Protein Metabolism

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age older than 18 years
  • ASA class I to III
  • colorectal surgery for non-metastatic disease (including right, transverse, left, sigmoid, subtotal, total and hemicolectomy and low anterior resection)
  • body mass index >17 and <30 kg.m-2
  • stable weight over the preceding three months (<10 % body weight loss)
  • serum albumin >35 g/L

Exclusion Criteria:

  • severe cardiac, renal or hepatic failure
  • diabetes
  • hyper and hypothyroidism
  • active inflammatory bowel or diverticular disease
  • musculoskeletal or neuromuscular disease
  • anemia (hematocrit <30)
  • albumin < 25 g/l
  • pregnancy
  • use of steroids.

Sites / Locations

  • Montreal General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Glucose and whey protein

Glucose only

Arm Description

Patients who are randomly allocated to this group will receive a drink made of anhydrous beet dextrose and pressurized whey protein in water (200 g/L + 100g/L). Patients will sip the drink for 4 hours of the 6 hour study.

The patients who are randomly allocated to this arm will receive a drink composed of anhydrous beet dextrose in water (200g/L). They will sip the drink for 4 hours of the 6 hour study.

Outcomes

Primary Outcome Measures

Protein balance
Protein balance is assessed using the stable isotope tracer C-13 leucine. Protein breakdown, protein synthesis and amino acid oxidation are measured through blood and expired air samples.

Secondary Outcome Measures

Full Information

First Posted
January 12, 2011
Last Updated
January 12, 2011
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
McGill University
search

1. Study Identification

Unique Protocol Identification Number
NCT01276795
Brief Title
Whey Protein-based Enteral Nutrition Support to Improve Protein Economy in Surgical Patients
Official Title
Whey Protein-based Enteral Nutrition Support to Improve Protein Economy in Surgical Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
McGill University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A prospective, randomized and controlled study is proposed to establish whether an enteral nutrition support regimen based on pressurized whey protein and glucose improves the postoperative utilization of amino acid substrates compared to a drink based on glucose alone. The kinetics of protein metabolism (protein breakdown, protein synthesis and amino acid oxidation) will be investigated using stable isotope methodology before and after surgery in patients undergoing colon resection. Stable isotope infusions will be conducted one week before surgery and on the second postoperative day for two hours in the fasted state and for four hours while sipping the enteral nutrition support regimen. Patients will consume one of two enteral nutrition support regimens consisting of a drink containing either pressurized whey protein and glucose or glucose alone. It is hypothesized that an enteral nutrition support regimen based on pressurized whey protein and glucose promotes positive protein balance through increased protein synthesis or reduced protein breakdown compared to glucose alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Protein Metabolism, Colorectal Neoplasms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucose and whey protein
Arm Type
Experimental
Arm Description
Patients who are randomly allocated to this group will receive a drink made of anhydrous beet dextrose and pressurized whey protein in water (200 g/L + 100g/L). Patients will sip the drink for 4 hours of the 6 hour study.
Arm Title
Glucose only
Arm Type
Active Comparator
Arm Description
The patients who are randomly allocated to this arm will receive a drink composed of anhydrous beet dextrose in water (200g/L). They will sip the drink for 4 hours of the 6 hour study.
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral Nutrition Support
Intervention Description
The patients will sip the oral nutrition support (in the form of a drink) over the course of 4 hours within each 6 hour study. Each patient will be studied once before surgery and once after surgery.
Primary Outcome Measure Information:
Title
Protein balance
Description
Protein balance is assessed using the stable isotope tracer C-13 leucine. Protein breakdown, protein synthesis and amino acid oxidation are measured through blood and expired air samples.
Time Frame
Assessed for 6 hours one time before surgery and once again on the second post-op day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age older than 18 years ASA class I to III colorectal surgery for non-metastatic disease (including right, transverse, left, sigmoid, subtotal, total and hemicolectomy and low anterior resection) body mass index >17 and <30 kg.m-2 stable weight over the preceding three months (<10 % body weight loss) serum albumin >35 g/L Exclusion Criteria: severe cardiac, renal or hepatic failure diabetes hyper and hypothyroidism active inflammatory bowel or diverticular disease musculoskeletal or neuromuscular disease anemia (hematocrit <30) albumin < 25 g/l pregnancy use of steroids.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco Carli, MD PhD
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Whey Protein-based Enteral Nutrition Support to Improve Protein Economy in Surgical Patients

We'll reach out to this number within 24 hrs