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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms; Protein Metabolism
• Intervention / Treatment: Dietary supplement: Oral Nutrition Support

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glucose and whey protein; 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.	Dietary supplement: Oral Nutrition Support; 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.
Active Comparator: Glucose only; 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.	Dietary supplement: Oral Nutrition Support; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Assessed for 6 hours one time before surgery and once again on the second post-op day

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: McGill University
• Investigators: Principal Investigator: Franco Carli, MD PhD, McGill University

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: January 12, 2011
• First Submitted That Met QC Criteria: January 12, 2011
• First Posted (Estimate): January 13, 2011

Study Record Updates

• Last Update Posted (Estimate): January 13, 2011
• Last Update Submitted That Met QC Criteria: January 12, 2011
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 09-053-SDR