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

January 12, 2011
January 12, 2011
January 2010
August 2010   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
Not Provided
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Whey Protein-based Enteral Nutrition Support to Improve Protein Economy in Surgical Patients
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
  • Protein Metabolism
  • Colorectal Neoplasms
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.
  • 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.
    Intervention: Dietary Supplement: Oral Nutrition Support
  • 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.
    Intervention: Dietary Supplement: Oral Nutrition Support
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
August 2010
August 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01276795
09-053-SDR
Yes
Dr. Francesco Carli, McGill University
McGill University Health Center
McGill University
Principal Investigator: Franco Carli, MD PhD McGill University
McGill University Health Center
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP