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

This study has been completed.
Sponsor:
Collaborator:
McGill University
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01276795
First received: January 12, 2011
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Protein Metabolism
Colorectal Neoplasms
Dietary Supplement: Oral Nutrition Support

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Whey Protein-based Enteral Nutrition Support to Improve Protein Economy in Surgical Patients

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Protein balance [ Time Frame: Assessed for 6 hours one time before surgery and once again on the second post-op day ] [ Designated as safety issue: No ]
    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.


Enrollment: 13
Study Start Date: January 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276795

Locations
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
McGill University Health Center
McGill University
Investigators
Principal Investigator: Franco Carli, MD PhD McGill University
  More Information

No publications provided

Responsible Party: Dr. Francesco Carli, McGill University
ClinicalTrials.gov Identifier: NCT01276795     History of Changes
Other Study ID Numbers: 09-053-SDR
Study First Received: January 12, 2011
Last Updated: January 12, 2011
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 22, 2014