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

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01276795
• Other study ID #: 09-053-SDR
• Status: Completed
• Phase: N/A
• First received: January 12, 2011
• Last updated: January 12, 2011
• Start date: January 2010
• Est. completion date: August 2010

Study information

• Verified date: July 2010
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Protein Metabolism

Intervention

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.

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Center	McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No